IEC 60601-2-52 CDV 2007-07-19 - PCB Assembly, PCB …€¦ · · 2010-06-0960601-2-52 © IEC:200Y...

60601-2-52 © IEC:200Y – 1 – 62D/NNN/CDV

CONTENTS

201.1 Scope, object and related standards ........................................................................... 8 201.1. 1 Scope......................................................................................... 8 201.1. 2 Object ........................................................................................ 8 201.1. 3 Collateral standards .................................................................... 8 201.1. 4 Particular standards .................................................................... 8

201.2 Normative references ................................................................................................. 9 201.3 Terms and definitions ................................................................................................. 9 201.4 General requirements ................................................................................................13 201.5 General requirements for testing of ME EQUIPMENT......................................................13

201.5.9.2.1.101 * Entrapment test TOOL..............................................14 201.5.9.2.1.102 Loading pad..............................................................14

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ..........................................................14 201.6.2 * Protection against electrical shock .........................................................15

201.7 ME EQUIPMENT identification, marking and documents..................................................15 201.7.2.2 Identification ..............................................................................15 201.7.2.2.101 * Marking of SAFE WORKING LOAD and maximum PATIENT

weight 15 201.7.2.2.102 – Marking for machine washable MEDICAL BEDS by a automatic

washing system .......................................................................................15 201.7.2.4 ACCESSORIES .............................................................................15 201.7.2.101 * Marking for MEDICAL BEDS intended for jet stream washing ........16 201.7.2.102 Width of carriage of BED-LIFT ......................................................16 201.7.2.4 * ACCESSORIES ...........................................................................16 201.7.4.2 Control devices ..........................................................................16 201.7.6.3 Symbols for controls and performance........................................16 201.7.9.2 Instructions for use ....................................................................18 201.7.9.2.1 General .....................................................................................18 201.7.9.2.2 * Warning and safety notices ......................................................18 201.7.9.2.5 ME EQUIPMENT description ..........................................................18 201.7.9.2.5.101 Selection of mattress ................................................18 201.7.9.2.5.102 * Angles and height of MEDICAL BED............................18 201.7.9.2.5.103 * Maximum mass of MEDICAL BED ...............................19

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ............................................19 201.8.1 19 201.8.11.3.2.1 Types ........................................................................................19

201.9 Protection against MECHANICAL hazards of ME EQUIPMENT and ME SYSTEMS ...................19 201.9.1 * MECHANICAL HAZARDS of ME EQUIPMENT ...................................................19 201.9.1.101 * Protection against PATIENT entrapment in non moving

parts 19 201.9.1.102 *Protection against inadvertent PATIENT falls ...............................23 201.9.2.2 TRAPPING ZONE ...........................................................................25 201.9.2.2.1 General .....................................................................................25 201.9.2.2.2 Gaps .........................................................................................25 201.9.2.2.3 Safe distances ...........................................................................27 201.9.2.2.5 Continuous activation.................................................................27 201.9.2.3.1 *Unintended movement ..............................................................27

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IEC 62D/JWG4, Circular no. 026-2007

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201.9.4.2.2.1 *Instability excluding transport....................................................28 201.9.4.2.3 Instability from horizontal and vertical forces ..............................30 201.9.4.2.4.3 Movement over a threshold ........................................................30 201.9.4.3.1 *Instability in transport ...............................................................31 201.9.4.3.2 Instability excluding transport .....................................................31 201.9.4.4 Grips and other handling devices ...............................................31 201.9.8 Hazards associated with support systems .................................................32 201.9.8.1 General .....................................................................................32 201.9.8.2 * TENSILE SAFETY FACTOR ............................................................32 201.9.8.3 Strength of PATIENT or OPERATOR support or suspension

systems 32 201.9.8.3.1 General .....................................................................................32 201.9.8.3.2 *Static forces due to loading from persons..................................34 201.9.8.3.3 * Dynamic forces due to loading from persons ............................35 201.9.8.3.3.101 * Dynamic testing of the height adjustment

mechanism 36 201.9.8.3.3.102 * SIDE RAIL strength and latch reliability .....................36 201.9.8.3 Systems with MECHANICAL PROTECTIVE DEVICES............................37 201.9.8.4.1 General .....................................................................................37

201.9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES .....................................37 201.10 Protection against unwanted and excessive radiation HAZARDS .............................38 201.11 Protection against excessive temperatures and other HAZARDS .............................38

201.11.1.1 Maximum temperature during NORMAL USE ..................................38 201.11.6.5.101 Ingress of water ........................................................38 201.11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEM .........39 201.11.6.6.101 Machine washable MEDICAL BED .................................39 201.11.8 * Interruption of the power supply/SUPPLY MAINS to

ME EQUIPMENT ..........................................................................................40 201.12 Accuracy of controls and instruments and protection against hazardous

outputs.......................................................................................................................40 201.12.2 Usability ....................................................................................40

201.13 HAZARDOUS SITUATIONS and fault conditions ..........................................................40 201.13.1.4 * Specific MECHANICAL HAZARDS ..................................................40 201.13.2.2 * Electrical SINGLE FAULT CONDITION ............................................41 201.13.2.2.101 Transport-power driven MEDICAL BED..........................41

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).............................................41 201.15 Construction of ME EQUIPMENT ..............................................................................41

201.15.3.4.1 HAND-HELD ME EQUIPMENT ...........................................................41 201.15.3.5 Rough handling test ...................................................................41 201.15.4 ME EQUIPMENT components and general assembly ......................42 201.15.4.7.3 Entry of liquids...........................................................................42 201.15.4.101 HEAD/FOOT board assembly ........................................................42 201.15.4.102 Mattress retention ......................................................................42 201.15.4.4 Indicators ..................................................................................42 201.15.4.6.2 *Limitation of movement.............................................................42 201.15.4.7.1 Mechanical strength ...................................................................44

201.16 ME SYSTEMS.........................................................................................................44 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ...........................44

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202 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests...............44

203 Medical electrical equipment – Part 1: General requirements for safety – Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment ............................................................................................................44

206 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability ......................................................................................44

208 Medical electrical equipment – Part 1-8: General requirements for safety – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ...................................44

209 Medical electrical equipment – Part 1-9: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the reduction of environmental impacts ............................45

210 Medical electrical equipment – Part 1-10: Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Process requirements for the development of therapeutic closed-loop controllers ..................................................................................................................45

Annex AA (informative) Particular guidance and rationale ...................................................46 Annex BB (informative) Design recommondations for MEDICAL BEDS ....................................60

Figures Figure 101 – APPLIED PART...................................................................................................10 Figure 102 – MEDICAL BED, general arrangement (example, schematic presentation

only) ..........................................................................................................................12 Figure 103 – Entrapment test TOOL ......................................................................................14 Figure 104 – Loading pad ...................................................................................................14 Figure 105 – Graphic symbol for maximum PATIENT weight (a) and SAFE WORKING LOAD

(b) .............................................................................................................................15 Figure 106 – MEDICAL BED function controls and/or actuators: guidelines for creating

graphic symbols .........................................................................................................17 Figure 107 – Example of MEDICAL BED with segmented or split SIDE RAIL ...............................20 Figure 108 – Example of MEDICAL BED with single piece SIDE RAIL .........................................21 Figure 109 – Descriptions of areas with SIDE RAIL height taking into account the

MATTRESS SUPPORT PLATFORM length ...........................................................................24 Figure 110 – Allowable spacings for fingers in areas of normal reach ...................................25 Figure 111 – Example using barriers for clearance measurement around the perimeter

of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment ...................26 Figure 112 a) – Foot clearance area....................................................................................26 Figure 112 b) – Toe clearance area.....................................................................................27 Figure 113 – Lateral stability test along the side of the MEDICAL BED .....................................29 Figure 114 – Longitudinal stability test with removable HEAD/FOOT BOARD .............................29 Figure 115 – Longitudinal stability test with fixed HEAD/FOOT BOARDS ....................................30 Figure 116 – Distribution of SAFE WORKING LOAD for tests .....................................................33 Figure 117 – Position of loading pad (see figure 104) ..........................................................35 Figure 118 – Application of forces for test of SIDE RAIL .........................................................37 Figure 119 a) – Angle γ between the back and the straight leg section of the MATTRESS

SUPPORT PLATFORM .....................................................................................................43 Figure 119 b) – Angle γ between the back and the angled leg section of the MATTRESS

SUPPORT PLATFORM .....................................................................................................43

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Figure 119 c) – Angle γ between the angled back and the angled leg section of the MATTRESS SUPPORT PLATFORM......................................................................................43

Figure 119 d) – Angle γ between the angled back and the straight leg section of the MATTRESS SUPPORT PLATFORM......................................................................................43

Figure AA.101 – Example Machine Wash Symbol ................................................................47 Figure AA.102 – Safety sign to select recommended mattresses specified by the

MANUFACTURER ...........................................................................................................48 Figure AA.103 – Resultant forces without mattress ..............................................................51 Figure AA.104 – Resultant forces with mattress ...................................................................51 Figure AA.105 – Example of 60 mm gap measurement of B .................................................51 Figure AA.106 – Angle measurement example of B..............................................................51 Figure AA.107 – Placement of measurement TOOL for measurement of D .............................52 Figure AA.108 – Example of area D measurement that passes ............................................52 Figure AA.109 – Example of area D measurement that fails .................................................52 Figure AA.110 – Example of area D measurement that fails .................................................53 Figure AA.111 – Example of potential PATIENT Entrapment in area A ....................................53 Figure AA.112 – Example of potential PATIENT entrapment in area A ....................................53 Figure AA.113 – Example of potential PATIENT entrapment in area B ....................................54 Figure AA.114 – Example of potential PATIENT entrapment in area C ....................................54 Figure AA.115 – Example of potential PATIENT entrapment in area C ....................................54 Figure AA.116 – Example of potential PATIENT entrapment in area D ....................................54 Figure AA.117 – Other areas of possible impact testing .......................................................57 Figure BB.101 – Impactor ...................................................................................................61 Figure BB.102 – Schematic presentation of under MEDICAL BED clearance ............................64 Figure BB.103 – Recommended angles for different sections of the MATTRESS SUPPORT

PLATFORM ...................................................................................................................65

Tables

*Table 101 – Protection against PATIENT entrapment ............................................................22 Table 102 – Protection against inadvertent PATIENT falls ......................................................24 Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BEDS

APPLIED PARTS ............................................................................................................38

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INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-52: Particular requirements for basic safety and essential

performance of medical beds

FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-52 has been prepared by IEC/ISO JWG 4 “Medical beds” of IEC technical committee 62 “Electrical equipment in medical practice”, subcommittee 62D “Electromedical equipment” and of ISO technical committee 173 “Assistive products for persons with disability”.

This first edition cancels and replaces first edition of IEC 60601-2-38 and IEC 60601-2-38/A1 and the European Standard EN 1970. This edition constitutes a technical revision.

The text of this particular standard is based on the following documents:

FDIS Report on voting

XX/XX/FDIS XX/XX/RVD

Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table.

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This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used: – Requirements and definitions: roman type. – Test specifications: italic type. – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.

In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:

− “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;

− “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;

− “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.

The committee has decided that the contents of this collateral standard will remain unchanged until the maintenance result date1) indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be – reconfirmed; – withdrawn; – replaced by a revised edition, or – amended

————————— 1) The National Committees are requested to note that for this publication the maintenance result date is 20YY.

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INTRODUCTION 1

In 1996, the IEC published the first edition of the particular standard for electrically operated 2 hospital beds, IEC 60601-2-38. The publication was in response to demand in the field for 3 universal standard addressing hazards specific to the safety of the hospital bed. Used in 4 conjunction with a MANUFACTURER’S RISK ASSESSMENT, the standard was felt to be the current 5 thinking on establishing a basic safety benchmark for industry. 6

An amendment of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a 7 RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the 8 MANUFACTURER’S RISK ASSESSMENT. Although this improved the particular standard, it still was 9 centered upon electrically operated hospital beds, and failed to take into account other 10 products in other medical environments. 11

In 2000, the EN 1970 standard (Adjustable beds for disabled persons – Requirements and 12 test methods) was published which addressed beds used to alleviate and compensate for a 13 disability of DISABLED PERSONS. This standard offered a broadened scope in conjunction with 14 IEC 60601-2-38, but after the edition of amendment 1 to IEC 60601-2-38, the opportunity 15 presented itself to combine the two standards to a common, international standard. 16

As work began on the integration, the IEC adjusted its stance on BASIC SAFETY and ESSENTIAL 17 PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became 18 necessary to align the new standard with the third edition. The particular standard was given 19 a new number, IEC 60601-2-52, and work began on alignment to third edition. 20

This particular standard, therefore, is the realization of much work in alignment, and scope 21 adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It 22 represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL 23 BED as used to alleviate illness of PATIENTS and disability of DISABLED PERSONS. This is the 24 effort of a joint working group of the IEC and the ISO. 25

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MEDICAL ELECTRICAL EQUIPMENT – 26 27

Part 2-52: Particular requirements for basic safety and essential 28 performance of medical beds 29

201.1 Scope, object and related standards 30

Clause 1 of the general standard applies, except as follows: 31

201.1.1 Scope 32

Subclause 1.1 of the general standard is replaced by: 33

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 34 MEDICAL BEDS, hereafter referred to as MEDICAL BED for adults as defined in 201.3.213. 35

If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to 36 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the 37 case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. 38

HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within 39 the scope of this standard are not covered by specific requirements in this standard except in 40 7.2.13 and 8.4.1 of the general standard. 41

NOTE See also 4.2 of the General Standard. 42

This standard can also be applied to MEDICAL BED used for compensation or alleviation of 43 disease, injury or disability. 44

201.1.2 Object 45


The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL 47 PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.213. 48

201.1.3 Collateral standards 49

Subclause 1.3 of the general standard applies with the following addition: 50

This particular standard refers to those applicable collateral standards that are listed in 51 Clause 2 of the general standard and Clause 201.2 of this particular standard. 52

IEC 60601-1-8; Medical electrical equipment – Part 1-8: General requirements for safety – 53 Collateral Standard: General requirements, tests and guidance for alarm systems in medical 54 electrical equipment and in medical electrical systems does not apply. 55

201.1.4 Particular standards 56


In the IEC 60601 series, particular standards may modify, replace or delete requirements 58 contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, 59 and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. 60

A requirement of a particular standard takes priority over the general standard. 61

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For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. 62 Collateral standards are referred to by their document number. 63

The numbering of sections, clauses and subclauses of this particular standard corresponds to 64 that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the 65 content of Clause 1 of the general standard) or applicable collateral standard with the prefix 66 “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in 67 this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral 68 standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 69 collateral standard, etc.). The changes to the text of the general standard are specified by the 70 use of the following words: 71

"Replacement" means that the clause or subclause of the general standard or applicable 72 collateral standard is replaced completely by the text of this particular standard. 73

"Addition" means that the text of this particular standard is additional to the requirements of 74 the general standard or applicable collateral standard. 75

"Amendment" means that the clause or subclause of the general standard or applicable 76 collateral standard is amended as indicated by the text of this particular standard. 77

Subclauses or figures which are additional to those of the general standard are numbered 78 starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), 79 bb), etc. 80

Subclauses or figures which are additional to those of a collateral standard are numbered 81 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-82 1-2, 203 for IEC 6060-1-3, etc. 83

The term "this standard" is used to make reference to the general standard, any applicable 84 collateral standards and this particular standard taken together. 85

Where there is no corresponding section, clause or subclause in this particular standard, the 86 section, clause or subclause of the general standard or applicable collateral standard, 87 although possibly not relevant, applies without modification; where it is intended that any part 88 of the general standard or applicable collateral standard, although possibly relevant, is not to 89 be applied, a statement to that effect is given in this particular standard. 90

201.2 Normative references 91

NOTE Informative references are listed in the bibliography beginning on page 46. 92

Clause 2 of the general standard applies. 93

201.3 Terms and definitions 94

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 95 apply, except as follows: 96

NOTE An index of defined terms is found beginning on page 67. 97

Terms of the general standard apply except as follows: 98

3.8 99 APPLIED PART 100 Addition: 101

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parts of the APPLIED PART (see figure 101) 102

103

Key: 104 1 Region of APPLIED PART 105

Figure 101 – APPLIED PART 106

3.76 107 PATIENT 108 Replacement: 109

person undergoing a medical, procedure, or DISABLED PERSON 110

3.131 111 * TRAPPING ZONE 112 Addition: 113

locations where the body of a MEDICAL BED occupant can become entrapped, entangled, 114 wedged, or stuck in or between parts of the MEDICAL BED, such as the SIDE RAILS, HEAD/FOOT 115 BOARD, MATTRESS SUPPORT PLATFORM or mattress. 116

Addition: 117

201.3.201 118 * APPLICATION ENVIRONMENT 1 119 intensive/critical care provided in a hospital where 24 h medical supervision and constant 120 monitoring is required and provision of life support system/equipment used in medical 121 procedures is essential to maintain or improve the vital functions of the PATIENT 122

201.3.202 123 * APPLICATION ENVIRONMENT 2 124 acute care provided in a hospital or other medical facility where medical supervision and 125 monitoring is required and ME EQUIPMENT used in medical procedures is often provided to help 126 maintain or improve the condition of the PATIENT 127

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201.3.203 128 * APPLICATION ENVIRONMENT 3 129 long term care in a medical area where medical supervision is required and monitoring is 130 provided if necessary and ME EQUIPMENT used in medical procedures may be provided to help 131 maintain or improve the condition of the PATIENT 132

NOTE This includes use in nursing homes, rehabilitation and geriatric facilities. 133

201.3.204 134 * APPLICATION ENVIRONMENT 4 135 care provided in a domestic area and ME EQUIPMENT is used to alleviate or compensate for an 136 injury, disability or disease 137

NOTE This excludes use in all other APPLICATION ENVIRONMENTs (e.g. nursing homes, rehabilitation and geriatric 138 facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4. 139

201.3.205 140 * APPLICATION ENVIRONMENT 5 141 outpatient (ambulatory) care, which is provided in a hospital or other medical facility, under 142 medical supervision and ME EQUIPMENT, is provided for the need of persons with illness, 143 injury or disability for treatment, diagnosis or monitoring 144

201.3.206 145 BED-LIFT 146 height adjustable UNDERCARRIAGE on which a MATTRESS SUPPORT PLATFORM can be mounted 147

NOTE This is serving as a height adjustable MEDICAL BED. 148

201.3.207 149 DISABLED PERSON 150 person with one or more impairments, one or more activity limitations, one or more 151 participation restrictions or a combination of these 152

[ISO/DIS 9999:2005] 153

201.3.208 154 HEAD/FOOT BOARD 155 assembly/assemblies mounted to MEDICAL BED, which identifies for the PATIENT the edge of the 156 head or foot end of the MEDICAL BED and/or MATTRESS SUPPORT PLATFORM 157

NOTE It may be used as handles to push the MEDICAL BED. 158

201.3.209 159 HOLD-TO-RUN-CONTROL 160 action, which initiates and maintains motion only as long as the device is held, the device 161 returns to the stop position when released thereby stopping the motion 162

201.3.210 163 LIFTING POLE 164 ACCESSORY attached to a MEDICAL BED and intended to assist support of a PATIENT when 165 changing position by providing a gripping support above the PATIENT 166

201.3.211 167 MATTRESS OVERLAY 168 supplementary mattress (surface), which is intended to be placed on a mattress (surface), and 169 generally used for prophylactic or therapeutic effect 170

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201.3.212 171 MATTRESS SUPPORT PLATFORM 172 structure, which supports a PATIENT surface (for example mattress) 173

NOTE It can articulate or change positions to facilitate various therapeutic, diagnostic and convenience positions 174 (See figures 102 and 119 a) to 119 d)) 175

176

Key 177 1 HEAD BOARD 178 2 Back section 179 3 Seat section 180 4 Upper leg section 181 5 Lower leg section 182 6 FOOT BOARD 183

Figure 102 – MEDICAL BED, general arrangement 184 (example, schematic presentation only) 185

201.3.213 186 * MEDICAL BED 187 device for which the INTENDED USE is sleeping/resting that contains a MATTRESS SUPPORT 188 PLATFORM and the device shall assist in diagnosis, monitoring, prevention, treatment, 189 alleviation of disease or compensation for an injury or handicap. 190

NOTE 1 A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible non-191 MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED. 192 NOTE 2 Excluded are devices for which the INTENDED USE is mainly for examination or transportation under 193 medical supervision (e.g. stretcher, examination table). 194

201.3.214 195 MOTION LOCKOUT CONTROL 196 auxiliary subsystem that deactivates motion controls 197

201.3.215 198 PENDANT CONTROL 199 handheld device, which has a FUNCTIONAL CONNECTION to the MEDICAL BED, controlling at least 200 MEDICAL BED articulations and/or movements 201

NOTE PENDANT CONTROLS may be wired, or wireless, and may integrate other functions, (e.g. communications, 202 radio/tv, etc.). 203

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201.3.216 204 SELF-RUN 205 condition associated with fault conditions characterized by a movement, which starts without 206 human intervention and continues in one direction until a mechanical limit is reached 207

201.3.217 208 SIDE RAIL 209 part, which may be a detachable ACCESSORY or integral to the overall construction of a 210 MEDICAL BED and is mounted to the side(s) of the MEDICAL BED 211

NOTE When a SIDE RAIL is located in the “up” position, it identifies the edge of the MATTRESS SUPPORT PLATFORM 212 and provides a physical barrier, which reduces the RISK of the PATIENT accidentally slipping or rolling off the 213 mattress. 214

201.3.218 215 SPECIALTY MATTRESS 216 mattress intended for prophylactic or therapeutic effect 217

201.3.219 218 TEST BED BOARD 219 flat, rigid loading board of dimensions as specified by the MANUFACTURER representing the 220 dimensions of the MEDICAL BED 221

201.3.220 222 UNDERCARRIAGE 223 all components of the MEDICAL BED or BED-LIFT below the MATTRESS SUPPORT PLATFORM 224

201.4 General requirements 225


201.5 General requirements for testing of ME EQUIPMENT 227


Additional subclauses: 229

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201.5.9.2.1.101 * Entrapment test TOOL 230

231

Key 232 Dimensions in mm 233

Figure 103 – Entrapment test TOOL 234

NOTE Further information for the design of the entrapment TOOL will be found in rationale to subclause 235 201.9.1.101 236

201.5.9.2.1.102 Loading pad 237

238

Figure 104 – Loading pad 239

201.6 Classification of ME EQUIPMENT and ME SYSTEMS 240


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201.6.2 * Protection against electrical shock 242

Addition: 243

For APPLICATION ENVIRONMENT 4 the MEDICAL BED shall be CLASS II. 244

201.7 ME EQUIPMENT identification, marking and documents 245


201.7.2.2 Identification 247

Replacement of 1st sentence: 248

The MEDICAL BED shall be marked with the name or trademark, address of the MANUFACTURER, 249 MODEL OR TYPE REFERENCE and means to allow traceability. 250

The detachable components shall be marked with the name or trademark, address of the 251 MANUFACTURER, MODEL OR TYPE REFERENCE and means to allow traceability unless mis-252 identification does not present an unacceptable RISK. 253


201.7.2.2.101 * Marking of SAFE WORKING LOAD and maximum PATIENT weight 255

The MEDICAL BED shall be marked with the corresponding maximum PATIENT weight (see 256 201.9.8.2.1) and SAFE WORKING LOAD (for symbol see Figure 105 a) and Figure 105 b)). 257

258

Figure 105 a) Figure 105 b) 259

Figure 105 – Graphic symbol for maximum PATIENT weight (a) and SAFE WORKING LOAD (b) 260

201.7.2.2.102 – Marking for machine washable MEDICAL BEDS by a automatic washing 261 system 262

MEDICAL BEDS intended for use with "jet stream" washing machines, high pressure/ steam 263 cleaning, etc. shall be marked to distinguish them from MEDICAL BEDS which cannot tolerate 264 such cleaning methods. Figures AA.101 may be used. 265

201.7.2.4 ACCESSORIES 266

Addition: 267

Where an overload on an ACCESSORY that are intended to support loads can create an 268 unacceptable RISK the corresponding SAFE WORKING LOAD shall be marked on the ACCESSORY. 269

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201.7.2.101 * Marking for MEDICAL BEDS intended for jet stream washing 271

MEDICAL BEDS intended for use with "jet stream" washing machines, high pressure/ steam 272 cleaning, etc. shall be marked (see figure AA.101 in Annex AA) 273

201.7.2.102 Width of carriage of BED-LIFT 274

If a BED-LIFT has an adjustable width carriage, the range shall be marked, e.g. by linear 275 measurement indicator fixed to the adjustable parts. 276

201.7.2.4 * ACCESSORIES 277

Addition: 278

MEDICAL BEDS designed to have replacement mattresses shall be marked with the following 279 sentence as a warning: “Incompatible mattresses can create HAZARDS. Read instructions for 280 use” or a symbol as appropriate (see example in AA.201.7.5.2). 281

MEDICAL BEDS designed to have detachable SIDE RAILS shall be marked with the following 282 sentence as a warning: “Incompatible side rails can create hazards. Read instructions for 283 use”. 284

201.7.4.2 Control devices 285

Addition: 286

Where reliance is placed on a MOTION LOCKOUT CONTROL which requires activation by the 287 OPERATOR, this shall be disclosed by markings on the outside of the MEDICAL BED and which 288 are visible from a position of NORMAL USE. 289

NOTE Example: “Engage the MOTION LOCKOUT CONTROL if a PATIENT could be injured due to inadvertent motion 290 of the MATTRESS SUPPORT PLATFORM.” 291

Compliance is checked by inspection of the MEDICAL BED. 292

201.7.6.3 Symbols for controls and performance 293

Addition: 294

Controls and/or indicators, when possible, shall be marked using symbols that convey the 295 intended function of those controls or indicators without the need for additional text. 296

NOTE Figure 106 is intended as a guideline when designing these symbols. In all cases where standard 297 international symbols exist, they should be used. 298

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299

300

301

302

Key 303 1 Back section down function 304 2 Back section up function 305 3 Leg down function 306 4 Leg up function 307 5 MATTRESS SUPPORT PLATFORM down 308 6 MATTRESS SUPPORT PLATFORM up 309 7 Trendelenburg 310 8 Anti-Trendelenburg/reverse Trendelenburg 311 9 Padlock-symbol (unlocked) 312 10 Padlock-symbol (locked) 313

Figure 106 – MEDICAL BED function controls and/or actuators: 314 guidelines for creating graphic symbols 315

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201.7.9.2 Instructions for use 316

201.7.9.2.1 General 317

Addition: 318

Instructions for use shall be provided which contribute to the safe operation of the MEDICAL 319 BED or BED-LIFT. When text is used for warning notices, they shall be in the official language(s) 320 of the country where the MEDICAL BED or BED-LIFT is placed on the market. 321

a) The instructions for use shall include a description according to 201.3. of the intended 322 APPLICATION ENVIRONMENT(S) 323

b) The instructions for use shall include the maximum PATIENT weight and SAFE WORKING 324 LOAD. The SAFE WORKING LOAD is the sum of: 325 – the PATIENT; 326 – the mattress; 327 – the ACCESSORIES of the MEDICAL BED (only if they are supported by the support system 328

of the MEDICAL BED); and 329 – the load supported by those ACCESSORIES (excluding PATIENT weight). 330

c) The instructions for use shall explain how to deactivate any MEDICAL BED function, which 331 might cause injury to the PATIENT, if movement of the MEDICAL BED occurs. 332

201.7.9.2.2 * Warning and safety notices 333

Addition: 334

a) The instruction for use shall provide a warning that the MEDICAL BED should be left in its 335 lowest position when the PATIENT is unattended in order to reduce RISK of injury due to 336 falls. 337

b) The instruction for use shall provide a warning on HAZARDS caused by inappropriate 338 handling of the POWER SUPPLY CORD, e. g. by kinking, shearing or other mechanical 339 damages. 340

c) The instructions for use shall provide a warning, stating when routing cables from other 341 equipment in the MEDICAL BED, precautions shall be taken to avoid squeezing those 342 between parts of the MEDICAL BED. 343

d) The instructions for use shall provide a warning if a MEDICAL BED shall only be used with 344 certain hoists, because of the limited space underneath the MEDICAL BED. 345

201.7.9.2.5 ME EQUIPMENT description 346


201.7.9.2.5.101 Selection of mattress 348

The instructions for use shall contain information on the selection of mattress(es), including 349 mattress dimensions and mattress characteristics (e.g. to reduce the RISK of entrapment and 350 falls (see also 201.7.5.2)). 351

201.7.9.2.5.102 * Angles and height of MEDICAL BED 352

The instructions for use shall identify the maximum angles, which can be achieved in NORMAL 353 USE by each part of the MATTRESS SUPPORT PLATFORM with reference to horizontal. They shall 354 also identify the maximum and minimum heights from the floor, which can be achieved by the 355 MATTRESS SUPPORT PLATFORM in NORMAL USE. They shall also identify any emergency 356 position(s) and the controls by which such position(s) are obtained. 357

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201.7.9.2.5.103 * Maximum mass of MEDICAL BED 358

The instructions for use shall identify the maximum mass of the MEDICAL BED. If the MEDICAL 359 BED is intended to be disassembled into parts, the maximum mass of any parts shall be stated 360 in the instructions for use. 361

201.8 Protection against electrical HAZARDS from ME EQUIPMENT 362


201.8.1 364

Addition: 365

c) Relay contacts stuck in open and closed position 366

201.8.11.3.2.1 Types 367

Replacement: 368

POWER SUPPLY CORDS shall be a minimum 2.5 m measured from the plug to the outside 369 perimeter of the MEDICAL BED. 370

POWER SUPPLY CORDS and other external flexible mains cables and cords on MEDICAL BEDS 371 shall have a sufficient quality for mechanical robustness (a national reference is given in [1]). 372

POWER SUPPLY CORD sets shall have a moulded-on plug or other means to withstand the 373 ingress of water during the cleaning PROCESS for which the MEDICAL BED is intended. 374

The MEDICAL BED shall be equipped with a means to keep the POWER SUPPLY CORD clear of any 375 moving MEDICAL BED part or mechanism, when the MEDICAL BED is in use, transport or not in 376 use to avoid a damage of the POWER SUPPLY CORD. 377

POWER SUPPLY CORDS shall be adequately protected against damages from contact with 378 moving part(s) or from friction at sharp corners and edges within the MEDICAL BED. 379

Compliance is checked by inspection 380

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 381


201.9.1 * MECHANICAL HAZARDS of ME EQUIPMENT 383


201.9.1.101 * Protection against PATIENT entrapment in non moving parts 385

Openings or areas (A1, A2, A3, A4, A5, A6, B, C, and D) within the MEDICAL BED system shall 386 meet the dimensional and constructional requirements of Figures 107, 108 and Table 101. 387 Where a RISK of PATIENT entrapment exists and is addressed in another way this shall be 388 justified by the MANUFACTURER in the RISK MANAGEMENT FILE. 389

Compliance is checked before and after application of the SIDE RAIL strength and latch 390 reliability tests (see 201.9.8.3.3.102). 391

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Compliance is checked with the MATTRESS SUPPORT PLATFORM in the flat position unless 392 otherwise noted as indicated in Table 101. The test shall be performed with the SIDE RAIL in all 393 raised and locked positions. 394

All the tests are performed without the mattress except the test for Dimension D. 395 Requirements involving the mattress are checked with the mattress(es) as specified by the 396 MANUFACTURER. Requirements of Figures 107, 108 and Table 101 involving the mattress are 397 excluded for SPECIALTY MATTRESSES. 398

A RISK ASSESSMENT shall be performed to evaluate: 399

– specialty mattresses; 400 – MATTRESS OVERLAYS; 401 – ACCESSORIES; 402 – articulated MATTRESS SUPPORT PLATFORM positions. 403

Compliance is checked by the following tests and inspection of the RISK MANAGEMENT FILE. 404

405

* Only applies when the Area C above is <60 mm. 406

Key 407 1 Area of TOOL representing neck diameter (60 mm). 408 2 Area of TOOL representing chest breadth (318 mm). 409 3 Area of TOOL representing head breadth (120 mm). 410 4 MATTRESS SUPPORT PLATFORM 411 5 HEAD BOARD 412 6 FOOT BOARD 413 7 Mattress 414

Figure 107 – Example of MEDICAL BED with segmented or split SIDE RAIL 415

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416

* Only applies when the Area C is <60 mm. 417

Key 418 1 Area of TOOL representing neck diameter (60 mm). 419 2 Area of TOOL representing chest breadth (318 mm). 420 3 Area of TOOL representing head breadth (120 mm). 421 4 MATTRESS SUPPORT PLATFORM 422 5 HEAD BOARD 423 6 FOOT BOARD 424 7 Mattress 425

Figure 108 – Example of MEDICAL BED with single piece SIDE RAIL 426

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*Table 101 – Protection against PATIENT entrapment 427

Area Description Requirement/Compliance method

A1 Fully enclosed openings within a SIDE RAIL, HEAD or FOOT BOARD

A2 Fully enclosed opening defined by the SIDE RAIL, its supports, and the MATTRESS SUPPORT PLATFORM

A3 Partially enclosed opening defined by the HEAD BOARD, MATTRESS SUPPORT PLATFORM, and SIDE RAIL

A4

Partially enclosed opening defined by the FOOT BOARD, MATTRESS SUPPORT PLATFORM, and SIDE RAIL (except where the gap between the SIDE RAIL and the FOOT BOARD >318 mm)

A5

Partially enclosed opening between segmented or split SIDE RAILS and the MATTRESS SUPPORT PLATFORM (except where the gap between the SIDE RAILS is >318 mm)

A6

Partially enclosed opening defined by the lowest point of a SIDE RAIL, the adjacent SIDE RAIL support, and MATTRESS SUPPORT PLATFORM, to the outside of the SIDE RAIL supports.

Other opening(s) defined by ACCESSORIES (e.g., IV poles, fracture frames) and SIDE RAILS, HEAD/FOOT BOARDS, and/or MATTRESS SUPPORT PLATFORM.

Nominal gap is specified to be less than 120 mm as defined by the following test.

Compliance is checked by the following test:

Insert 60 mm cylindrical end of test TOOL with cone and cylinder attached (See figures 107 and 108) through opening from inside of the MEDICAL BED system. Bring cone end of TOOL to bear on opening of interest. Exert 50 N force applied to end of cylinder in most disadvantageous direction.

– MEDICAL BEDS with a full length single piece SIDE RAIL: Articulate the MEDICAL BED and find the largest opening and perform test.

Pass/fail criterion: Opening shall not allow 120 mm diameter cone part of TOOL to pass through.

B

Distance between the MATTRESS SUPPORT PLATFORM and the lowest point of the SIDE RAIL outside of the SIDE RAIL support.

AND

The angle between SIDE RAIL and the MATTRESS SUPPORT PLATFORM at the range of the mattress height defined by the MANUFACTURER ±2 cm. NOTE ±2 cm takes into account mattress compression and height of the neck above the mattress.

Gap <60 mm.

AND

Angle between MATTRESS SUPPORT PLATFORM and the SIDE RAIL interface >60 degrees over the entire range of mattress heights from the minimum recommended mattress height, minus 2 cm. to the maximum recommended mattress height, plus 2 cm. NOTE The RISK MANAGEMENT has to address the possibility of the use of a mattress not specified by the MANUFACTURER.

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C

Nominal gap between the HEAD BOARD and adjacent SIDE RAIL.

Gap between segmented or split SIDE RAILS with both SIDE RAILS raised

Gap between SIDE RAIL and FOOTBOARD.

Other openings(s) defined by ACCESSORIES (e.g. IV poles, fractures frames,…..) and SIDE RAILS, HEAD BOARD, FOOT BOARD, and / or MATTRESS SUPPPORT PLATFORM.

Nominal gap between the HEAD BOARD and adjacent SIDE RAIL is required to be <60 mm.

Gap between segmented or split SIDE RAILS with both SIDE RAILS raised is required to be <60 mm

OR >318 mm.

Gap between SIDE RAIL and FOOTBOARD is required to be <60 mm OR >318 mm.

Compliance for a gap <60 mm is checked by the following test:

The test TOOL (cone and cylinder attached) shall be oriented parallel to floor, in the most disadvantageous angle in the horizontal plane above the gap. The 60 mm cylinder portion of TOOL shall rest with the full weight of the TOOL on gap where the cylinder and cone parts of TOOL intersect. Extra vertical force shall not be used. The TOOL shall not be used to pry apart parts of the MEDICAL BED.

For MEDICAL BED with split SIDE RAILS articulate the MATTRESS SUPPORT PLATFORM to identify the worst case opening between the SIDE RAILS and perform the test.

Pass/fail criterion:

The 60 mm cylinder part of the TOOL shall not slide through the opening.

OR

For a gap >318 mm:

The gap shall be >318 mm for the entire vertical distance.

*D

Region defined between the SIDE RAIL and the mattress.

Compliance is checked by the following test:

Push the mattress away from the SIDE RAIL being measured until the mattress retention system, or the opposing SIDE RAIL stops the mattress. Pull outward to remove any lateral play and during application of the force the cone is placed with its longitudinal axis parallel to the SIDE RAIL, resting on the mattress in the horizontal gap between the SIDE RAIL and mattress. Turn the cone until the line on the face of the 120 mm diameter end is horizontal. Let the cone sink into the space by its own weight.

If a mattress retention system, SIDE RAIL support or other structure keeps the cone from sinking in the gap, the cone shall be placed at a different location along the rail where there is no interference.

Pass/fail criterion:

The large end of the TOOL shall not sink below the mattress surface by more than 50 % of its 120 mm diameter.

201.9.1.102 *Protection against inadvertent PATIENT falls 428

SIDE RAILS shall be designed with minimum height requirements as indicated by G in Figure 429 109 and Table 102. 430

Where a SPECIALTY MATTRESS or MATTRESS OVERLAY is used and does not meet G as indicated 431 in Table 102 a RISK ASSESSMENT shall be performed to assure equivalent safety. 432

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Compliance is checked by measurement of G and inspection of the RISK MANAGEMENT FILE. 433

434

Key 435 1 MATTRESS SUPPORT PLATFORM 436 2 FOOT BOARD 437 3 HEAD BOARD 438 4 Mattress 439 G Height of the top edge of the SIDE RAIL above the mattress 440

Figure 109 – Descriptions of areas with SIDE RAIL height taking into account the 441 MATTRESS SUPPORT PLATFORM length 442

Table 102 – Protection against inadvertent PATIENT falls 443

Designator Description Requirement

G

Height of the top edge of the SIDE RAIL above the mattress without compression in at least 50 % of the length of the MATTRESS SUPPORT PLATFORM. Other raised and locked positions not meeting the height of ≥220 mm for SIDE RAILS and specified for purposes other than SIDE RAIL application (e.g. grab handles) shall be covered in the MANUFACTURERS RISK MANAGEMENT FILE. When SIDE RAILS cover less than the full length of the MATTRESS SUPPORT PLATFORM, those parts that are above 220 mm shall be placed strategically to help prevent accidental falls from the MEDICAL BED. Dimension C of Table 101 shall be respected.

NOTE Placement of the 220 mm portions of the rail may need to be placed next to those parts of the body that are highest (e.g. shoulder and hips for a PATIENT lying on their side) in order to prevent accidental rollout. See fig A.19, IEC 60601-1 3rd edition for guidance on distribution of body mass.

≥220 mm

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201.9.2.2 TRAPPING ZONE 444

201.9.2.2.1 General 445

Addition: 446

The entire region in the UNDERCARRIAGE shall be considered in the RISK ANALYSIS with regard 447 to trapping HAZARDS due to high/low motion. 448

Compliance is checked by inspection of the RISK MANAGEMENT FILE. 449

201.9.2.2.2 Gaps 450

Addition: 451

A TRAPPING ZONE is considered not to present a MECHANICAL HAZARD to fingers if the gaps of 452 the TRAPPING ZONE comply with the dimensions of Figures 110 and 111. 453

A TRAPPING ZONE is considered not to present a MECHANICAL HAZARD to the foot if the gaps of 454 the TRAPPING ZONE comply with the dimensions of Figures 112 a) and 112 b). 455

Distances between moving parts shall always be either less than 8 mm or more than 25 mm 456

457

Key 458 1 Foot-end 459 2 FOOT BOARD 460 3 HEAD BOARD 461 4 Head end 462

Figure 110 – Allowable spacings for fingers in areas of normal reach 463

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464

Key 465 1 Pinch point 466 2 MATTRESS SUPPORT PLATFORM 467

Figure 111 – Example using barriers for clearance measurement around the perimeter 468 of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment 469

470

Key 471 For area where b <= 130 mm 472 shall always be a >= 120 mm 473 or shall always be a <= 35 mm 474 NOTE The dimension “a” is only measured from the floor. The dimension “b” is measured from the outer edge of 475 the MEDICAL BED. Including ACCESSORIES (e.g. SIDE RAIL), if applicable 476

Figure 112 a) – Foot clearance area 477

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478

Key 479 For area where b between 130 to 180 mm 480 shall always be c >= 50 mm 481 or shall always be c <= 35 mm 482 NOTE The dimension “a” is only measured from the floor. The dimension “b” is measured from the outer edge of 483 the MEDICAL BED. Including ACCESSORIES (e.g. SIDE RAIL), if applicable 484

Figure 112 b) – Toe clearance area 485

Measurements shall be done in the most disadvantageous condition for Figure 110, 111, 112 486 a) and Figure 112 b). 487

201.9.2.2.3 Safe distances 488

Amendment: 489

For the reach of a hand the safe distance is 200 mm (see Figure 110 and Figure 111). 490

201.9.2.2.5 Continuous activation 491

Delete a) 492

Replacement of b): 493

b) All movement of the MEDICAL BED or its parts shall be possible only by the activation of 494 HOLD-TO-RUN-CONTROLS. 495

NOTE Manually and foot operated movements are considered to comply with this clause, as long as mass and 496 velocity allow adequate control of positioning without causing an unacceptable RISK. 497

Compliance is checked by inspection. 498

201.9.2.3.1 *Unintended movement 499

Addition: 500

Except for emergency MEDICAL BED movements specified by MANUFACTURER, MEDICAL BEDS 501 shall incorporate means to deactivate MEDICAL BED movement controls, such as those in 502 PENDANT CONTROL and/or SIDE RAIL function controls intended to be available to the PATIENT, 503 OPERATOR, or visitor. 504

Except for emergency MEDICAL BED movements specified by the MANUFACTURER, the means to 505 deactivate MEDICAL BED movement (such as those in PENDANT CONTROL and/or SIDE RAIL 506 function controls intended to be activated to the PATIENT, OPERATOR, or visitor) shall be 507

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located in a position such that they cannot be accidentally re-activate by the PATIENT when the 508 PATIENT is in the MEDICAL BED. 509


The means to deactivate foot-operated MEDICAL BED movement shall be located or designed 511 such that a PATIENT cannot accidentally re-activate the functions, taking into account PATIENT 512 mobility and medical supervision. 513

If the MEDICAL BED design cannot exclude trapping or crushing due to accidental activation on 514 the foot operated control by the PATIENT, OPERATOR or visitor, there shall be a means to 515 deactivate any foot operated controls used for any MEDICAL BED movement which is not 516 manually operated. The control shall deactivate without OPERATOR action after use. 517


Foot operated controls shall be designed to prevent accidental activation. Consideration shall 519 be given to unintended activation by the PATIENT or other persons crawling under the MEDICAL 520 BED or by objects used in close proximity. 521


201.9.4.2.2.1 *Instability excluding transport 523

Addition: 524

When the following tests are performed, the MEDICAL BED shall not overbalance (tip over) with 525 the height and length of the MATTRESS SUPPORT PLATFORM, castors, SIDE RAILS and other 526 ACCESSORIES with their SAFE WORKING LOAD in their most adverse position of NORMAL USE, and 527 the MEDICAL BED equipped with the lightest mattress as specified by the MANUFACTURER or a 528 load representing the weight of the specified mattress that is uniformly distributed and 529 centered on the MATTRESS SUPPORT PLATFORM. 530

Compliance is checked by the following tests conducted with the MATTRESS SUPPORT PLATFORM 531 in the flat and horizontal position. 532

Lateral stability test: 533

A load of 2200 N is placed at the side edge of the MATTRESS SUPPORT PLATFORM and evenly 534 distributed over an area 250mm X 950mm (see Figure 113). 535

If the maximum PATIENT load according to the MANUFACTURER exceeds 2 200 N, the maximum 536 PATIENT mass is to be used and is evenly distributed over an area 950 mm long and 250 mm 537 wide (see Figure 113 below). 538

Perform the test at each corner of the MEDICAL BED. 539

Longitudinal stability test: 540 a) If the HEAD/FOOT BOARDS are removable without the use of TOOLS: 541 Remove the HEAD BOARD or the FOOT BOARD as appropriate, a load of 2 200 N for 542

APPLICATION ENVIRONMENTS 1,2,3,5 and 1 850 N for APPLICATION ENVIRONMENT 4 is evenly 543 distributed over an area of 250 mm across the full width of the MEDICAL BED (see Figure 544 114). 545

If the maximum PATIENT load according to the MANUFACTURER exceeds 2 200 N (or 1 850 N 546 for APPLICATION ENVIRONMENT 4), the maximum PATIENT load is to be used. 547

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Perform the test at each end of the MEDICAL BED in application 4 and at the foot end only 548 for APPLICATION ENVIRONMENTS 1,2,3,5 as applicable. 549

b) If the HEAD/FOOT BOARDS are permanently fixed or require the use of TOOLS to remove 550 them: 551

A load of 1 100 N for APPLICATION ENVIRONMENTS 1,2,3,5 and 925 N for APPLICATION 552 ENVIRONMENT 4 is evenly distributed over an area of 250 mm x 475 mm (figure 115). 553 Perform the test at both ends of the MEDICAL BED. 554

555

Key 556 1 2 200 N evenly distributed. 557

Figure 113 – Lateral stability test along the side of the MEDICAL BED 558

559

Key 560 1 2 200 N, (1 850 N for APPLICATION ENVIRONMENT 4), evenly distributed. 561

Figure 114 – Longitudinal stability test with removable HEAD/FOOT BOARD 562

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563 Key 564 1 1 100 N, (925 N for APPLICATION ENVIRONMENT 4), evenly distributed. 565

Figure 115 – Longitudinal stability test with fixed HEAD/FOOT BOARDS 566

201.9.4.2.3 Instability from horizontal and vertical forces 567

Replacement: 568

b) The MEDICAL BED shall not overbalance (tip over) due to sitting or stepping. 569

NOTE Requirements for PATIENT support surfaces are found in 201.9.8.3. 570

Compliance is checked by inspection and by the following test: 571

The MEDICAL BED is placed on a horizontal plane and a constant downward force of 1 100 N is 572 applied at the point of maximum moment to any working surface, excluding the MATTRESS 573 SUPPORT PLATFORM, offering an obvious foothold or sitting surface of a minimum 20 cm by 574 20 cm area, and at a height not exceeding 1 m from the floor. Prior to the test the MEDICAL BED 575 is prepared as described in 201.9.4.2.2.1. 576

201.9.4.2.4.3 Movement over a threshold 577

Replacement: 578

MOBILE MEDICAL BED intended to transport PATIENTS shall withstand the stresses caused by 579 rough handling. The following threshold test shall be used. 580

This requirement does not apply to a MEDICAL BED specified by the MANUFACTURER to be 581 moved within the PATIENT room for cleaning or PATIENT access. 582

Compliance is checked by the following test: 583

The SIDE RAILS are raised and latched, with all other ACCESSORIES intended for NORMAL USE 584 during transport attached to the MEDICAL BED and with the SAFE WORKING LOAD in place and the 585 height in the worst case position. 586

The MEDICAL BED shall be moved at a speed of 0,8 m/s ± 0,1 m/s, or for motor driven MEDICAL 587 BEDS, the maximum speed shall be used, while all castors shall impact and pass over an 588 obstruction which is fixed flat on the floor, with a rectangular cross-section, 20 mm high and 589 80 mm deep. The MEDICAL BED, with all castors, shall then be pulled back over the obstruction 590 and back to the starting position of the test. 591

This is repeated 10 times. 592

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Acceptance criteria for MOBILE and motor driven MEDICAL BED: 593

At the end of the test, the MEDICAL BED, MEDICAL BEDS parts, ACCESSORIES shall present no loss 594 of function, and without unlocking/unlatching of the SIDE RAILS, or physical deterioration, (e.g., 595 deterioration of fixings, unlocking of ACCESSORIES if fixed on the MEDICAL BED (like SIDE RAILS), 596 which can reduce the NORMAL USE or create a RISK like collapsing, or permanent deformation, 597 modifying gap for entrapment or pinching etc.). 598

The MEDICAL BED shall go over the obstruction. The MEDICAL BED shall not overbalance (tip 599 over). The MEDICAL BED or MEDICAL BED parts shall not present an unacceptable RISK. 600 Unacceptable RISK is determined by inspection of the MEDICAL BED, its parts, and relevant 601 information from the RISK MANAGEMENT FILE. 602

201.9.4.3.1 *Instability in transport 603

Replacement of c): 604

MOBILE MEDICAL BED that is intended to be used on the floor shall not result in an unacceptable 605 RISK due to unwanted horizontal movement. 606


Prior to the test, the MEDICAL BED is prepared with the following in the most disadvantageous 608 position of NORMAL USE: 609

– the height, articulation, and length of the MATTRESS SUPPORT PLATFORM 610 – castors 611 – SIDE RAILS 612 – ACCESSORIES with their SAFE WORKING LOAD in place, including in combination with other 613

accessories 614 – mattress (e.g. height and weight) as specified by the MANUFACTURER or a load 615

representing the weight of the specified mattress that is uniformly distributed and centered 616 on the MATTRESS SUPPORT PLATFORM. 617

The MOBILE MEDICAL BED is placed with the SAFE WORKING LOAD in place, and the locking 618 device (e.g. brakes) activated, on a plane covered with 2 mm to 4 mm thick vinyl flooring 619 material and inclined at 6° from the horizontal plane on a concrete floor. Following initial 620 elastic movement, initial creepage, and initial pivoting of castors, there shall be no movement 621 of the MOBILE MEDICAL BED greater than 50 mm (in relation to the inclined plane). Any initial 622 movement shall not result in an unacceptable RISK, taking into account the NORMAL USE of the 623 MEDICAL BED. 624

201.9.4.3.2 Instability excluding transport 625

Replacement of a): 626

See clause 201.9.4.3.1. 627

201.9.4.4 Grips and other handling devices 628

This subclause does not apply to APPLICATION ENVIRONMENT 1,2,3,5. 629

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201.9.8 HAZARDS associated with support systems 630

201.9.8.1 General 631

Amendment: 632

Delete first dash. 633

201.9.8.2 * TENSILE SAFETY FACTOR 634

Amendment: 635

This subclause does not apply (see 201.9.8.3.2). 636

201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems 637

201.9.8.3.1 General 638

Replacement: 639

MEDICAL BED parts serving for support or immobilization of the PATIENT shall be designed to 640 minimize the RISK of physical injuries and of accidental loosening of fixings. 641

The SAFE WORKING LOAD of the MEDICAL BED shall be at least 1 700 N. It is considered to be the 642 sum of the following minimum loads: 643

– 1 350 N, corresponding approximately to a mass of 135 kg for the PATIENT. 644 – 200 N, corresponding approximately to a mass of 20 kg for the mattress. 645 – 150 N, corresponding approximately to a mass of 15 kg for both the ACCESSORIES and the 646

mass of the load supported by those ACCESSORIES but excluding PATIENT weight. 647

The SAFE WORKING LOAD of a BED-LIFT shall be at least 2 200 N. It is considered to be the sum 648 of the following minimum loads: 649

– 1 350 N, corresponding approximately to a mass of 135 kg for the PATIENT. 650 – 200 N, corresponding approximately to a mass of 20 kg for the mattress. 651 – 150 N, corresponding approximately to a mass of 15 kg for both the ACCESSORIES and the 652

mass of the load supported by those ACCESSORIES but excluding PATIENT weight. 653 – 500 N, corresponding approximately to a mass of 50 kg for those parts of the MEDICAL BED 654

intended to be lifted by the BED-LIFT. 655

If the SAFE WORKING LOAD as specified by the MANUFACTURER is greater than 1 700 N for 656 MEDICAL BEDS or 2 200 N for BED-LIFTS, it shall be used as a basis for testing. 657

The SAFE WORKING LOAD is distributed as shown in Figure 116. 658

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659

Key 660 1 Back-Rest 661 2 Seat Section 662 3 Upper leg section 663 4 Lower leg section 664 5 SWL = SAFE WORKING LOAD 665

Figure 116 – Distribution of SAFE WORKING LOAD for tests 666

For a foot rest, the part of the SAFE WORKING LOAD representing the mass of PATIENTS is 667 distributed over an area of 0,1 m2 or whatever is available. 668

NOTE The position of the human body varies depending on the configuration of the support/suspension system 669 and therefore the load acting on different sections will vary and should be taken into account. In analyzing loading 670 forces and torques on support assemblies, the part of the SAFE WORKING LOAD representing the mass as defined, it 671 shall be placed at the worst-case position permitted by the configuration or ACCESSORIES attachment on the 672 support/suspension parts. 673

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The SAFE WORKING LOAD of the LIFTING POLE (included PATIENT handle) shall be at least 750 N 674

201.9.8.3.2 *Static forces due to loading from persons 675

Replacement: 676

The MEDICAL BED shall be capable of withstanding a uniformly distributed static load equal to 677 twice the SAFE WORKING LOAD or 4 000 N, whichever is greater, in the most disadvantageous 678 height and length with the MATTRESS SUPPORT PLATFORM in a horizontal position. 679

When impairment by wear, corrosion, material fatigue or aging is expected, relevant 680 supporting parts shall have a safety factor not less than 4 times the SAFE WORKING LOAD. 681

For MEDICAL BEDS: 682


Permanent deformation is acceptable only if the MEDICAL BED is in compliance with its NORMAL 684 CONDITION. The static load shall be applied for at least 1 minute, unless material creep may be 685 an issue in which case the time shall be increased to at least 1 hour. 686

For BED-LIFTS: 687


Mount a TEST BED BOARD to a BED-LIFT not supplied with a bed board. 689

Place the mattress, as specified by the MANUFACTURER, onto the bed board/TEST BED BOARD, in 690 its flat position. 691

If height-adjustable, the bed board/TEST BED BOARD shall be placed in the middle of the 692 possible range of the adjustment. 693

Apply a vertical load of 2 times the SAFE WORKING LOAD or 4 000 N whichever is greater 694 (excluding the mass of the mattress placed onto the MEDICAL BED or the mass of the TEST BED 695 BOARD) equally distributed over the mattress. Remove the test load and the mattress or TEST 696 BED BOARD after 1 h. 697

For MEDICAL BEDS and BED-LIFTS: 698

The MEDICAL BED shall function normally and not present any unacceptable RISK after the test. 699

All ACCESSORIES (including those not supporting PATIENT weight) shall be designed to support 700 a load that is at least two times the SAFE WORKING LOAD specified for the ACCESSORY. This load 701 is applied in the most disadvantageous direction and position on the ACCESSORIES. 702


With the ACCESSORY in its worst case NORMAL USE position, attach a static load equal to two 704 times its SAFE WORKING LOAD for 1 minute (1 hour for products in which material creep is a 705 concern). There shall be no HAZARD or loss of function. 706

The fastenings of LIFTING POLES shall still function normally and present no HAZARDS after the 707 following test: 708

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Position the LIFTING POLE to the MEDICAL BED in its most adverse position intended for use. 710

Apply a downward load of 2 x SAFE WORKING LOAD of LIFTING POLES (at least 1 500N) to the 711 outermost suspension point for the handle. Examine the LIFTING POLE and its fastenings during 712 and after application of the load. 713

NOTE This is a test of the fastenings of the LIFTING POLE and not of the LIFTING POLE as such, therefore any 714 permanent set of the LIFTING POLE is allowed for this test. 715

201.9.8.3.3 * Dynamic forces due to loading from persons 716

Replacement: 717

Where dynamic forces (due to sitting down, standing up, PATIENT handling PROCESS or the 718 like) can be exerted on equipment parts intended to support or suspend a PATIENT in NORMAL 719 USE, they shall not result in an unacceptable RISK. 720

Durability shall be considered with regards to the most disadvantageous position of the 721 equipment parts intended to support or suspend a PATIENT in NORMAL USE. 722

Compliance is checked by the following tests: 723

Condition of test: 724

Place the worst-case mattress specified by MANUFACTURER onto the MEDICAL BED in its flat 725 position. If height-adjustable, adjust the height to the worse case position. Utilize loading pad 726 (Figure 104) at the position A in Figure 117, at the side which ever is regarded to be the 727 weaker. 728

Centerline 729

730

Key 731 1 Head-end of MEDICAL BED 732 2 Foot-end of MEDICAL BED 733

Figure 117 – Position of loading pad (see figure 104) 734

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Test method: 735

Apply the loading pad (figure 104) 10 000 times at the position A shown in Figure 117, with a 736 load of 1 350 N or the maximum PATIENT load, whichever is greater. 737

Acceptance Criteria/Compliance Method: 738

When tested in accordance with the above the MEDICAL BED shall still function normally and 739 present no HAZARDS after removal of the loading pad. 740

Remove the mattress and perform the following: 741

– evaluate entrapment HAZARDS according to 201.9.1.101; 742 – evaluate TRAPPING ZONES according to 201.9.2.2; 743 – conduct test according to 201.9.8.3.2 744


201.9.8.3.3.101 * Dynamic testing of the height adjustment mechanism 746

The height adjustment of MEDICAL BED or BED-LIFT shall function normally and present no 747 unacceptable RISK after 3 000 cycles in NORMAL USE. 748


Place the MEDICAL BED in its flat position. If the BED-LIFT is separate from a MATTRESS SUPPORT 750 PLATFORM, mount a TEST BED BOARD to the BED-LIFT. Apply the SAFE WORKING LOAD distributed 751 as indicated in clause 201.9.8.3.3 (figure 116) on the MATTRESS SUPPORT PLATFORM .For BED-752 LIFTS apply the SAFE WORKING LOAD minus the weight of the TEST BED BOARD distributed as 753 indicated in clause 201.9.8.3.3 (figure 116) on the MATTRESS SUPPORT PLATFORM. 754

The MEDICAL BED, or BED-LIFT is raised and lowered completely 3 000 times in accordance with 755 the procedure stated in the instructions for use. After the test remove the SAFE WORKING LOAD. 756

201.9.8.3.3.102 * SIDE RAIL strength and latch reliability 757

SIDE RAIL latches/locks shall remain secure when subjected to the forces of NORMAL USE. 758

Compliance is checked by the following test. Forces are applied at the worst-case accessible 759 location: 760

Cycle the SIDE RAIL mechanism (from the latched, upper position, to the unlatched, lowered 761 position, and back to the latched, upper position) for 30 000 cycles. A force (as specified in 762 figure 118) shall then be applied to the worst-case position for locking/latching of the SIDE RAIL 763 in the direction of unlatching/unlocking. The SIDE RAIL shall not become unlatched/unlocked or 764 create any other unacceptable RISK. 765

SIDE RAILS shall be designed to withstand the forces applied during reasonably foreseeable 766 misuse over the product life cycle without creating an unacceptable RISK. 767


a) Lateral force cycling test. Exert a force of 100 N that is perpendicular to the SIDE RAIL at 769 the top middle section of the SIDE RAIL in the direction indicated by E, or F in Figure 118. 770 Reverse direction. Repeat for 3 000 cycles. 771

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b) Longitudinal force cycling test. Exert a force of 100 N on the SIDE RAIL in the lengthwise 772 direction of the SIDE RAIL as indicated by C, or D in Figure 118. Reverse direction. Repeat 773 for 3 000 cycles. 774

c) Vertical force cycling test. Exert a force of 100 N on the SIDE RAIL in the vertical direction 775 of the SIDE RAIL as indicated by B in Figure 118. Repeat for 3 000 cycles .No test required 776 in direction A. 777

d) Upon completion of a), b) and c) above, apply a static load as in Figure 118. The SIDE RAIL 778 shall not become unlatched/unlocked or create any other unacceptable RISK. 779

NOTE The MANUFACTURER shall take into account when these forces can be applied in the lowered position. 780

781

Figure 118 – Application of forces for test of SIDE RAIL 782

201.9.8.3 Systems with MECHANICAL PROTECTIVE DEVICES 783

201.9.8.4.1 General 784

Addition: 785

This subclause does not apply to MEDICAL BED where the suspension system operates in 786 compression rather than in tension. 787

201.9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES 788

Addition: 789

This subclause does not apply to MEDICAL BED where the suspension system operates in 790 compression rather than in tension. 791

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201.10 Protection against unwanted and excessive radiation HAZARDS 792


201.11 Protection against excessive temperatures and other HAZARDS 794


201.11.1.1 Maximum temperature during NORMAL USE 796

Replacement: 797

Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BEDS APPLIED PARTS

Maximum temperature a b °C

APPLIED PARTS of MEDICAL BEDS

Metal and liquids

Glass, porcelain, vitreous material

Moulded material,

plastic, rubber, wood

t < 1 min 51 56 60

1 min ≤ t < 10 min 48 48 48 APPLIED PART having contact with the PATIENT for a time “t ”

10 min ≤ t 41 41 41

a These temperature limit values are applicable for the healthy skin of adults. They are not applicable when large areas of the skin (10 % of total body surface or more) can be in contact with a hot surface. They are not applicable in the case of skin contact with over 10 % of the head surface. Where this is the case, appropriate limits shall be determined and documented in the RISK MANAGEMENT FILE.

b Where it is necessary for APPLIED PARTS to exceed the temperature limits of Table 24 in order to provide clinical benefit, the RISK MANAGEMENT FILE shall contain documentation showing that the resulting benefit exceeds any associated increase in RISK.

Additional subclause: 798

201.11.6.5.101 Ingress of water 799

ENCLOSURES of MEDICAL BED shall provide a minimum protection degree of IPX4 in accordance 800 with the classification of IEC 60529. 801

Compliance is checked by the tests of IEC 60529 with the MEDICAL BED placed in the least 802 favourable position of NORMAL USE (as defined in the instructions for use) and by inspection: 803

All parts that can be removed without a TOOL shall be removed (detached/opened) before the 804 test. Test shall be executed without a mattress. After these procedures, the MEDICAL BED shall 805 show no signs of bridging of insulation [or electrical components] that could result in a HAZARD 806 in NORMAL CONDITION or in combination with a SINGLE FAULT CONDITION (based on a visual 807 inspection) followed by the appropriate dielectric strength and LEAKAGE CURRENT tests. 808

The MEDICAL BED shall comply with its INTENDED USE. 809

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201.11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEM 810

Addition: 811

If the MEDICAL BED is intended for use with equipment for cleaning and disinfection the 812 MANUFACTURER has to specify the cleaning and/or disinfection PROCESS. 813


201.11.6.6.101 Machine washable MEDICAL BED 815

MEDICAL BED or BED-LIFT specified by the MANUFACTURER to be machine washable by an 816 automatic washing system shall function normally after the test. 817

Variations to the test procedure regarding temperature, time and cleaning fluids shall be 818 covered in the RISK MANAGEMENT FILE of the MANUFACTURER. 819

The present test method is representing a basic procedure for disinfection of a MEDICAL BED in 820 a washing machine. 821


a) parts and access covers which can be detached/opened without the use of a TOOL shall be 823 detached/opened; 824

– temperature preconditioning treatment of 10 days at 65 °C ± 2 °C or at maximum value 825 of the rated storage temperature, if higher, is carried out; 826

– the MEDICAL BED shall then be kept at room temperature for not less than 16 hours; 827 b) 50 test cycles according to the procedure the MANUFACTURER described in the instruction 828

for use or consisting of: 829 – 2 minutes wash with 70 °C water at a ph-value 5-8, 0,5 % cleaning and disinfectant 830

solution as specified by the MANUFACTURER; 831 – 20 seconds rinse with 85 °C water at a ph-value 5-8, and 0,2 % clear rinsing solution 832

according to the data of the MANUFACTURER. 833 – 10 minutes cooling at 20 °C ambient temperature. 834 – Acceptance criteria: 835

1) Immediately after the test cycles, the MEDICAL BED is connected to mains. No 836 unintentional movements shall arise. 837

2) The MEDICAL BED shall function as specified by the INTENDED USE at the following 838 intervals: 839 – immediately after the test cycles; 840 – 5 min (±1 min) after the test cycles; 841 – 60 min (±5 min) after the test cycles; 842 – 24 h (±30 min) after the test cycles; 843

3) Perform dielectric strength and leakage current tests according to 8.8.3 and 8.7 at 844 the following intervals: 845 – immediately after the test cycles 846 – 24 h (±30 min) after the test cycles 847

4) Perform a visual inspection for ingress of water that may result in an unacceptable 848 RISK (i.e., shorting of isolation barriers and violation of creepage distances). 849

NOTE For some MEDICAL BED not all acceptance criteria apply (i.e. for manual MEDICAL BEDS, electrical 850 acceptance criteria would not apply). 851

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201.11.8 * Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT 852

Addition: 853

In an emergency situation when MAINS VOLTAGE has been interrupted, ESSENTIAL PERFORMANCE 854 functions defined by the MANUFACTURER shall be operated by other means and backrest 855 lowering or any other emergency position (specified by the MANUFACTURER) shall be 856 achievable within 30 s. 857

Compliance is checked by inspection in the most adverse conditions. 858

201.12 Accuracy of controls and instruments and protection against 859 hazardous outputs 860


201.12.2 USABILITY 862

Addition: 863

USABILITY analysis shall take into account MEDICAL BED design aspects such as the MATTRESS 864 SUPPORT PLATFORM height, with regard to both OPERATOR and PATIENT, as relevant to the 865 APPLICATION ENVIRONMENT. 866

NOTE Access to PATIENT for the purposes of medical treatment shall not be delayed significantly by the SIDE 867 RAILS and their respective control systems. 868

201.13 HAZARDOUS SITUATIONS and fault conditions 869


201.13.1.4 * Specific MECHANICAL HAZARDS 871

Addition: 872

Protection shall be provided in the motion controls of electrical MEDICAL BED such that a single 873 fault does not cause a SELF-RUN. 874

NOTE A MOTION LOCKOUT CONTROL may be used as a means of compliance. A MOTION LOCKOUT CONTROL may be 875 activated automatically or as an OPERATOR option. (See also clause 201.7.4.2.). 876

If a MOTION LOCKOUT CONTROL is provided, it shall not be deactivated under SINGLE FAULT 877 CONDITION. 878

For switches and other components that control motion in electrical MEDICAL BED, COMPONENTS 879 WITH HIGH-INTEGRITY CHARACTERISTICS are required if their failure can cause a HAZARD. 880

Hydraulic, pneumatic, and mechanical subsystems of electrical or non-electrical MEDICAL BED 881 shall not cause unintended movement of the MATTRESS SUPPORT PLATFORM in SINGLE FAULT 882 CONDITION, where such movement could cause a HAZARD. 883

Protection of SINGLE FAULT CONDITION for non-electrical pneumatic, hydraulic, or mechanical 884 BEDS, or for pneumatic, hydraulic, or mechanical subsystems of electrical MEDICAL BED, shall 885 be met by compliance with 9.7.2 of the general standard, and other applicable clauses of the 886 general standard and this standard pertaining to safety factors. 887

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201.13.2.2 * Electrical SINGLE FAULT CONDITION 888

Addition: 889

Requirements protecting the MEDICAL BED against SINGLE FAULT CONDITION that correspond to 890 13.1.4 for electrical circuits controlling motion include, but are not limited to: 891

a) Open circuit or short circuit condition internal to a component. 892 b) Short circuit of one functional insulation between closely spaced adjacent component 893

leads or circuit traces. 894 c) Relay contacts stuck in an open or closed position. 895

Requirements of a), b), and c may be omitted where it can be demonstrated that components 896 or conductors are not subject to a particular failure mode(s). 897

201.13.2.2.101 Transport-power driven MEDICAL BED 898

Transport-power driven MEDICAL BEDS shall have a means to allow transport by the OPERATOR 899 under SINGLE FAULT CONDITION of the transport system. 900

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 901


201.15 Construction of ME EQUIPMENT 903


201.15.3.4.1 HAND-HELD ME EQUIPMENT 905

Replacement: 906

PENDANT CONTROL shall not resolve in an unacceptable RISK as a result of a free fall. 907


The PENDANT CONTROL has to fall 1.000 times as specified in IEC 60068-2-32. 909

After the test the PENDANT CONTROL is checked by inspection, functional test and relevant 910 electrical safety tests 911

201.15.3.5 Rough handling test 912

Replacement of c): 913

c) Door frame shock 914

The sample is moved three times in its normal direction of travel at a speed of 915 0,4 m/s ± 0,1 m/s with the MATTRESS SUPPORT PLATFORM in the worst case position, unless 916 transport position is specified by the MANUFACTURER, against a hardwood vertical obstacle 917 having a width and thickness of 40 mm affixed to a vertical rigid support (e.g. concrete). The 918 height of the vertical obstacle shall be at the same level as the MEDICAL BED contact point(s). 919 The direction of movement is perpendicular to the face of the obstacle. 920

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Addition at the end of the paragraph: 921

This requirement does not apply to MEDICAL BED specified by the MANUFACTURER only to be 922 moved within the PATIENT room for cleaning or PATIENT access. 923

201.15.4 ME EQUIPMENT components and general assembly 924

201.15.4.7.3 Entry of liquids 925

Amendment: 926

Foot operated controls shall be at least IPX4. 927


201.15.4.101 HEAD/FOOT BOARD assembly 929

The design of the MEDICAL BED shall allow immediate and unimpeded access to the PATIENT 930 from the head end of the MEDICAL BED in emergency situations. This applies for APPLICATION 931 ENVIRONMENT 1, 2 only. 932

NOTE One means of accomplishing this is by a HEAD BOARD, which is removable without the use of a TOOL by 933 one person. 934

201.15.4.102 Mattress retention 935

The MEDICAL BED shall be designed to retain the mattress in position during NORMAL USE to 936 prevent sliding off MATTRESS SUPPORT PLATFORM. 937

201.15.4.4 Indicators 938

Amendment: 939

Delete the first two paragraphs. 940

201.15.4.6.2 *Limitation of movement 941

Addition: 942

The angle (designated “γ” in figure 119) between the back section and leg/upper leg section 943 for various configurations of the MATTRESS SUPPORT PLATFORM shall always be greater than 944 90° under NORMAL CONDITIONS. 945

In APPLICATION ENVIRONMENT 4 the back section shall always be greater than or equal zero 946 degrees in relation to the horizontal 947

Compliance is checked by operating the controls to achieve the maximum angle γ and then 948 measuring this angle. 949

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950

Figure 119 a) – Angle γ between the back and the straight leg section 951 of the MATTRESS SUPPORT PLATFORM 952

953

954

Figure 119 b) – Angle γ between the back and the angled leg section 955 of the MATTRESS SUPPORT PLATFORM 956

957

958

Figure 119 c) – Angle γ between the angled back and the angled leg section 959 of the MATTRESS SUPPORT PLATFORM 960

961

962

Key 963 1 Back section 964 2 Leg section 965 3 Upper leg section 966 4 Seat section 967 5 Lower leg section 968

Figure 119 d) – Angle γ between the angled back and the straight leg section 969 of the MATTRESS SUPPORT PLATFORM 970

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201.15.4.7.1 Mechanical strength 971

Replacement of first sentence of b): 972

Foot-operated control devices of the MEDICAL BED shall be able to support the weight of an 973 adult human being, where the person’s entire weight might be placed on it in NORMAL USE. 974

Addition to b): 975

Where the entire weight cannot be placed on the foot-operated control device then the RISK 976 MANAGEMENT FILE shall specify the compliance criteria. 977

Compliance is checked by inspection of the RISK MANAGEMENT FILE. 978

201.16 ME SYSTEMS 979


201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 981


202 Medical electrical equipment – Part 1-2: General requirements for safety – 983 Collateral standard: Electromagnetic compatibility – Requirements and 984 tests 985

IEC 60601-1-2:2001 applies. 986

203 Medical electrical equipment – Part 1: General requirements for safety – 987 Collateral standard: General requirements for radiation protection in 988 diagnostic X-ray equipment 989

IEC 60601-1-3:200y does not apply. 990

206 Medical electrical equipment – Part 1-6: General requirements for safety – 991 Collateral standard: Usability 992

IEC 60601-1-6:200y applies except as follows: 993

…. 994

208 Medical electrical equipment – Part 1-8: General requirements for safety – 995 Collateral Standard: General requirements, tests and guidance for alarm 996 systems in medical electrical equipment and medical electrical systems 997


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209 Medical electrical equipment – Part 1-9: Medical electrical equipment – 999 Part 1-9: General requirements for basic safety and essential performance 1000 – Collateral Standard: Requirements for the reduction of environmental 1001 impacts 1002

IEC 60601-1-9:200y applies. 1003

210 Medical electrical equipment – Part 1-10: Medical electrical equipment – 1004 Part 1-10: General requirements for basic safety and essential 1005 performance – Collateral Standard: Process requirements for the 1006 development of therapeutic closed-loop controllers 1007


All Annexes of the general standard (Annex A to Annex L) apply. 1009

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Annex AA 1010 (informative) 1011

1012 Particular guidance and rationale 1013

AA.1 General guidance 1014

In 1996, the IEC published the first edition of the particular standard for electrically operated 1015 hospital beds, IEC 60601-2-38. The publication was in response to demand in the field for 1016 universal standard addressing HAZARDS specific to the safety of the hospital bed. Used in 1017 conjunction with a MANUFACTURER’S RISK ASSESSMENT, the standard was felt to be the current 1018 thinking on establishing a basic safety benchmark for industry. 1019

An amendment of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a 1020 RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the 1021 MANUFACTURER’S RISK ASSESSMENT. Although this improved the particular standard, it still was 1022 centered upon electrically operated hospital beds, and failed to take into account other 1023 products in other medical environments. 1024

In 2000, the EN 1970 standard (Adjustable beds for disabled persons – Requirements and 1025 test methods) was published which addressed beds used to alleviate disability of DISABLED 1026 PERSONS. This standard offered a broadened scope in conjunction with IEC 60601-2-38, but 1027 after the edition of amendment 1 to IEC 60601-2-38, the opportunity presented itself to 1028 combine the two standards to a common, international standard. 1029

As work began on the integration, the IEC adjusted its stance on BASIC SAFETY and ESSENTIAL 1030 PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became 1031 necessary to align the new standard with the third edition. The particular standard was given 1032 a new number, IEC 60601-2-52, and work began on alignment to third edition. 1033

This particular standard, therefore, is the realization of much work in alignment, and scope 1034 adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It 1035 represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL 1036 BED as used to alleviate illness of PATIENTS and disability of DISABLED PERSONS. This is the 1037 effort of a joint working group of the IEC and the ISO. 1038

AA.2 Rationale for particular clauses and subclauses 1039

The following are rationales for specific clauses and subclause in this particular standard, with 1040 clause and subclause numbers parallel to those in the body of the document. 1041

Subclause 1.1 – Scope 1042

The working group recognises that the definitions of the terms “adult” and “child” are based on 1043 physical characteristics, which vary from one country to another. If the highest level of safety 1044 is to be achieved for PATIENTS and OPERATORS, is necessary to rely on caregivers to use their 1045 professional judgement to differentiate the needs of children from those of adults in relation to 1046 the ME EQUIPMENT, taking into consideration not only the physical, psychological and medical 1047 needs of the individual, but also the PATIENT’s preference. The dimensional requirements of 1048 this Particular Standard are based on anthropometric data based on PATIENTS ranging in 1049 physical size from a 146 cm tall female to a 185 cm tall male. For BEDS intended for use with 1050 PATIENTS outside this range, all dimensional characteristics in this Particular Standard should 1051 be adjusted accordingly. 1052

Definition 201.3.131 – TRAPPING ZONE 1053

The term “entrapment” describes an event in which a PATIENT is caught, trapped, or entangled 1054 in spaces in or about the SIDE RAIL, mattress, or MEDICAL BED frame. 1055

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Definition 201.3.201 – APPLICATION ENVIRONMENT 1, 2, 3, 4, 5 1056

The working group discussed many different APPLICATION ENVIRONMENTS in evaluating this 1057 particular standard. For example, a maternity bed designed to aid in the birthing process is 1058 primarily used with PATIENTS below the age of 50. These PATIENTS generally do not fit into a 1059 high entrapment RISK category, thus entrapment guidelines may not be considered, unless the 1060 product is designed to be used in various APPLICATION ENVIRONMENTS in NORMAL USE, or there 1061 is reasonable foreseeable misuse. 1062

Definition 201.3.213 – MEDICAL BED 1063

This particular standard merges two pre-existing standards: IEC 60601-2-38 (Particular 1064 requirements for the safety of electrically-operated hospital beds), and EN 1970 (Adjustable 1065 beds for disabled persons – requirements and test methods). Since different products exist 1066 within different health-care markets, requirements are divided into different APPLICATION 1067 ENVIRONMENTS. Certain products may exist across APPLICATION ENVIRONMENTS, or different 1068 APPLICATION ENVIRONMENTS may develop in the future that are not specified in this particular 1069 standard. The environment of use has to be addressed through the MANUFACTURER’S RISK 1070 MANAGEMENT PROCESS. 1071

Subclause 201.6.2 – Protection against electrical shock 1072

In some countries a protective earth connection may not be available or reliable in the home 1073 environment (APPLICATION ENVIRONMENT 4). 1074

Subclause 201.7.2.2.101 – Marking of SAFE WORKING LOAD 1075

It is important that the RESPONSIBLE ORGANIZATION and/or OPERATOR clearly understand the 1076 maximum PATIENT weight and SAFE WORKING LOAD of the MEDICAL BED, and of any ACCESSORY 1077 that is intended to support potentially hazardous masses, so that the MEDICAL BED and its 1078 ACCESSORIES are not used in ways, which could create a HAZARD. 1079

Subclause 201.7.2.2.102 – Marking for machine washable MEDICAL BEDS by a automatic 1080 washing system 1081

A marking for machine washable MEDICAL BEDS by an automatic washing system is shown in 1082 Figure AA.101. 1083

1084

Figure AA.101 – Example Machine Wash Symbol 1085

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Subclause 201.7.5.2 – Safety signs 1086

1087

Key 1088 h = height of mattress 1089 L = length of mattress 1090 L = width of mattress 1091

Figure AA.102 – Safety sign to select recommended mattresses 1092 specified by the MANUFACTURER 1093

Subclause 201.7.9.2.5.102 – Angles and height of MEDICAL BED 1094

When determining the adjustable height range of the MEDICAL BED, consideration should be 1095 given to regional anthropometrics for both caregiver and/or OPERATOR and/or PATIENT. 1096

Attention should be paid to: 1097

– PATIENT falls out of the MEDICAL BED, where a low height minimizes injuries. 1098 – Ease of PATIENT entry and egress. 1099

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– Transfers to and from a wheelchair. 1100 – Caregivers and/or OPERATORS safe working height in order to minimize back problems. 1101

Subclause 201.7.9.2.5.103 – Maximum mass of MEDICAL BED 1102

Where a MEDICAL BED may be disassembled for transport by hand, knowledge of the mass of 1103 the main parts may be useful in avoiding strain. 1104

Subclause 201.9.1 – MECHANICAL HAZARDS of ME EQUIPMENT 1105

General rationale for 201.9.1.101, and 201.9.1.102: There are various recognized RISKS that 1106 have been accepted on the basis of RISK/benefit or RISK/RISK tradeoffs. SPECIALTY 1107 MATTRESSES are excluded from evaluation since the clinical benefits derived from such 1108 mattresses should clearly outweigh the RISKS involved with their use, and because the 1109 prescribed test requirements in this standard cannot be met without compromising its clinical 1110 benefit of the SPECIALTY MATTRESS. 1111

The requirements are only applied with the MATTRESS SUPPORT PLATFORM in the flat position 1112 unless otherwise indicated. The reason is that there are various clinical benefits associated 1113 with the ability of MEDICAL BEDS to perform various articulations. It is not apparent how the 1114 functionality of MEDICAL BEDS, particularly the most advanced, most clinically beneficial beds, 1115 could be preserved if the requirements were extended to articulated positions. 1116 MANUFACTURERS are encouraged to understand the RISK involved and to strive to minimize 1117 this RISK by analysis and novel approaches to mitigation, while maintaining clinical utility of 1118 the bed. 1119

The dimensional requirements form a baseline, but they are not relevant to every bed 1120 application, and they may occasionally interfere with intended usage without mitigating RISK. 1121 The MANUFACTURER is responsible for justifying deviations for specialty beds or surfaces in the 1122 RISK ANALYSIS. 1123

Subclause 201.9.1.101 – Protection against PATIENT entrapment in non-moving parts 1124

The dimensional requirements listed in Figures 107 and 108 and in Table 101 are intended to 1125 restrict openings in and around the MEDICAL BED system so that parts of the anatomy cannot 1126 enter or can pass through easily. Each requirement is based on commonly available 1127 anthropometric data. PATIENTS most vulnerable to entrapment are those who have cognitive 1128 disability or have uncontrolled body movement. These PATIENTS most often are frail, elderly or 1129 confused. Few adverse event reports indicate the angular position of the MATTRESS SUPPORT 1130 PLATFORM in which entrapment occurs, or what position the SIDE RAILS are in. Therefore this 1131 particular standard recommends that entrapment be evaluated by the MANUFACTURER’s RISK 1132 ASSESSMENT in flat and articulated bed positions, with the SIDE RAILS fully raised and in 1133 intermediate positions. 1134

Three key body parts at RISK for life-threatening entrapment in MEDICAL BED systems are the 1135 head, neck, and chest. 1136

Head 1137

The 120 mm dimension is based on the 5th percentile Sri Lanka female head breadth, the 1138 distance across the face from ear to ear. Gaps <120 mm were chosen as this dimension 1139 represents a conservative measurement to reduce entrapment. A dimension of 120 mm 1140 includes all 5th percentile smallest female head breadth references and most 1st percentile 1141 international references. 1142

In case of mattress specifically dedicated to the MEDICAL BED and SIDE RAIL and if sliding of the 1143 mattress on the SUPPORT MATTRESS PLATFORM is not possible the test is performed by inserting 1144 the 60 mm cylindrical end of test TOOL with 120 mm cone between mattress and SIDE RAIL 1145 (A area). 1146

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Neck 1147

The 60 mm dimension is based on the 5th percentile width of a small adult female neck. 1148

It is noted that people of small stature have a 1st percentile female neck diameter of 79 mm 1149 (5th percentile = 83 mm.). Several factors, such as neck compressibility, loss of muscle mass 1150 in the neck as PATIENTS age, and the asymmetrical shape of the neck, all support a 1151 conservative measure of less than 60 mm. 1152

To reduce the RISK of neck entrapment, gaps in the MEDICAL BED system should be small 1153 enough to prevent passage of a small neck. Additionally to reduce neck entrapment with 1154 regards to wedging of the neck, angles for V-shaped openings (Reference EN 13451-1) 1155 should be greater than 60 degrees. The 60 degree angle reflects an understanding that at 1156 some point, a narrow angle creates a v-shape space or geometry that could be conducive to 1157 entrapment. The 60 degrees angle was chosen by reviewing the TOOLS to assess entrapment 1158 RISK for swimming pool equipment (EN 13451-1,Swimming Pool Equipment – Part 1: General 1159 Safety Requirements and Test Methods), and a corresponding mathematical analysis which 1160 shows that when a cylinder-shaped weight is supported by two offsetting force vectors, each 1161 of the perpendicular forces becomes equal to the weight of the cylinder when the angles 1162 relative to the vertical are 60 degrees. An assumption is made that 60 degrees may be 1163 considered to be an inflection point for angles where wedging may become a prominent 1164 consideration (see figures AA.106 an AA.107). 1165

Chest 1166

The 318 mm is based on the 95th percentile male chest depth. There have been reports of 1167 chest entrapment in MEDICAL BEDS in the space between split SIDE RAILS. To avoid chest 1168 entrapments, the spaces should be wide enough (greater than 318 mm) to allow a large chest 1169 to slip through without being entrapped. 1170

Specification of TOOL used to evaluate entrapment see Figure 103. 1171

Rationale for measurement of B 1172

The measurement of area B includes two separate measurements: a measurement of the gap 1173 beneath the SIDE RAIL (see Figure AA.105), and a measurement of the interface angle at the 1174 mattress height, plus and minus 2 cm (Figure AA.106). The decision to include the mattress in 1175 the measurement of the interface angle comes from an analysis of the forces on a neck with 1176 and without the mattress (figures AA.103 and AA.104). It is demonstrated that the mattress 1177 plays a significant part in entrapment where there is a wedging effect. It is understood that the 1178 measurement is done at the mattress height as specified by the MANUFACTURER. The 1179 measurement should represent a most adverse condition of the MEDICAL BED (i.e., smallest 1180 thickness mattress –2 cm, and thickest mattress +2 cm). 1181

The angle measurements are taken for the range defined by (4) in figure AA.106. For complex 1182 geometries in this range, measure to the tangential(s) of the SIDE RAIL. 1183

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Key

1 Normal force from SIDE RAIL

2 Normal force from MATTRESS SUPPORT PLATFORM

3 Neck

4 Resultant (ejecting) force

Figure AA.103 – Resultant forces without mattress

Key

1 Normal force from SIDE RAIL

2 Normal force to neck from mattress

3 Neck

4 Resultant force from mattress

5 Mattress

Figure AA.104 – Resultant forces with mattress

Key

1 SIDE RAIL

2 MATTRESS SUPPORT PLATFORM

3 Gap Measurement (<60 mm)

Figure AA.105 – Example of 60 mm gap measurement of B

Key

1 Mattress

2 SIDE RAIL

3 Mattress height(s) (specified by MANUFACTURER)

4 Angle measurement zone

Figure AA.106 – Angle measurement example of B

1184

Rationale for measurement of D 1185

Area D is the space between the inside surface of the SIDE RAIL and the mattress compressed 1186 by the weight of a PATIENT'S head. The space should be small enough to prevent head 1187 entrapment when taking into account the mattress compressibility, any lateral shift of the 1188 mattress or SIDE RAIL, and degree of play from loosened SIDE RAILS. IEC recommends a 1189 dimension of less than 120 mm because the head is presumed to enter the space before the 1190 neck. 1191

The goal of testing Area D is to assess if a PATIENT could trap his head in the horizontal space 1192 between the mattress and inside of the SIDE RAIL. 1193

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Additional figures and examples of measurement of D 1194

1195

Key 1196

1 SIDE RAILS 1197 2 Mattress 1198 3 Cone of cone and cylinder TOOL 1199

Figure AA.107 – Placement of measurement TOOL for measurement of D 1200

Key

1 SIDE RAIL

2 Mattress

3 Cone of cone and cylinder TOOL


Figure AA.108 – Example of area D measurement that passes

Key

1 SIDE RAIL

2 Mattress

3 Cone of cone and cylinder TOOL


Figure AA.109 – Example of area D measurement that fails

1201

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1202

Key 1203 1 SIDE RAIL 1204 2 Mattress 1205 3 Cone of cone and cylinder TOOL 1206 4 MATTRESS SUPPORT PLATFORM 1207

Figure AA.110 – Example of area D measurement that fails 1208

Rationale on SIDE RAIL intermediate height entrapment determination 1209

It is recognized that certain designs of SIDE RAILS have the additional INTENDED USE of an 1210 intermediate position to aid the PATIENT in entrance and egress of the product or nursing the 1211 PATIENT in the MEDICAL BED (e.g. feeding). The intermediate position can provide an ergonomic 1212 advantage to the PATIENT or caregiver. A MANUFACTURER shall evaluate this and other 1213 ACCESSORIES that provide this advantage, to ensure that safety is provided against the 1214 foreseeable misuse of leaving the SIDE RAIL or ACCESSORY in this position with the PATIENT 1215 unattended, if doing so is not the INTENDED USE of the intermediate position. It is recognized 1216 that such reasonably foreseeable misuse may increase the RISK of entrapment or falls. It is 1217 the responsibility of the MANUFACTURER to evaluate this RISK against the benefit given to the 1218 PATIENT and to determine if the entrapment and fall requirements apply in an intermediate 1219 position. 1220

Some artist sketches are provided below in order to demonstrate how entrapment may occur 1221 in each of the areas: 1222

Figure AA.111 – Example of potential PATIENT Entrapment in area A

Figure AA.112 – Example of potential PATIENT entrapment in area A

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Figure AA.113 – Example of potential PATIENT entrapment in area B

Figure AA.114 – Example of potential PATIENT entrapment in area C

1223

Figure AA.115 – Example of potential PATIENT entrapment in area C

Figure AA.116 – Example of potential PATIENT entrapment in area D

1224 Subclause 201.9.1.102 – Protection against inadvertent PATIENT falls 1225

The requirement for SIDE RAILS to cover at least 50 % of the length of the MATTRESS SUPPORT 1226 PLATFORM is intended to ensure that SIDE RAILS reduce the RISK of the PATIENT accidentally 1227 slipping or rolling off the mattress. 1228

Due to the nature of the SIDE RAIL entrapment HAZARD, compliance with the listed dimensional 1229 requirements is not in itself considered adequate to address all possible dangers (including 1230 entrapment of legs and arms, or the RISK of a PATIENT falling from an attempt to climb over the 1231 SIDE RAILS). For this reason, an additional requirement to perform a RISK ASSESSMENT 1232 (evaluating all issues pertaining to SIDE RAILS) has been included. 1233

The 220 mm dimension is the minimum height requirement for the top edge of a SIDE RAIL 1234 above the mattress and is based on the midpoint (center of gravity) of an adult male torso at 1235 the 95th percentile lying on a compressed mattress. 1236

The minimum height requirement for SIDE RAILS may increase the RISK of injury when a 1237 PATIENT climbs over and falls. The minimum length requirement on SIDE RAILS may increase 1238 entrapment RISK by reducing egress points for the PATIENT, and while it may decrease 1239 inadvertent fall RISK from rolling out of MEDICAL BED, it may increase RISK where PATIENTS may 1240 opt to climb over the SIDE RAILS. The dimensional requirements in this particular standard 1241 reflect an attempt to make the best RISK tradeoffs on the basis of available information. Future 1242 data may demonstrate that some of these requirements should be revised at a future date. 1243

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Subclause 201.9.2.3.1 – Unintended movement 1244

The probability of inadvertent motion due to component failure is significantly reduced when 1245 the lockout is engaged. 1246

Several accidents have occurred involving foot-operated control pedals where PATIENTS, 1247 OPERATOR or visitors were injured or killed in the UNDERCARRIAGE of MEDICAL BEDS. The 1248 majority of the reported accidents occurred in long-term care environments. The factors of 1249 primary significance are: 1250

– the existence of exposed MECHANICAL HAZARDS in the moving UNDERCARRIAGE, 1251 – foot-operated control design which allows inadvertent activation, especially by unintended 1252

users, 1253 – intermittent caregiver supervision, PATIENTS or OPERATORS accidentally falling or crawling 1254

over the control, and 1255 – PATIENT, resident, or visitor characteristics such that the OPERATOR of the control lacks 1256

normal adult judgment. 1257

Some of these factors need to exist simultaneously to create a HAZARD of mechanical injury in 1258 the MEDICAL BED UNDERCARRIAGE, so elimination of some may eliminate the RISK. The RISK for 1259 this HAZARD varies with the care environment. In APPLICATION ENVIRONMENT 1 and APPLICATION 1260 ENVIRONMENT 5 (intensive care and ambulatory), PATIENTS are generally under nearly 1261 continuous supervision, which minimizes RISK without regard to PATIENT characteristics or the 1262 MEDICAL BED design. RISK is comparatively high in long-term care unless protections are 1263 implemented in the MEDICAL BED design, because of intermittent caregiver supervision and 1264 resident mobility and/or mental characteristics of the MEDICAL BED occupants. 1265

Experience in some countries with foot control (some incidents over recent years, including 1266 several deaths) shows that: 1267

– Incidents are more frequent in long-term services and with weak, disoriented or agitated 1268 PATIENTS but some other incidents occurred in acute care services or intensive care 1269 services and with normal adult judgement PATIENT. 1270

– foot controls can generate an unacceptable RISK regarding its utility. 1271 – A manual disconnection of foot controls or MOTION LOCKOUT SYSTEM, without an other 1272

safety system, may not be an adequate solution to prevent unacceptable RISK because this 1273 function is not used consistently by OPERATOR. 1274

Subclause 201.9.4.2.2.1 – Instability excluding transport 1275

Use of 1 100 N for PATIENT weight 1276

1 100 N is used to simulate a PATIENT, resident or visitor weight. 110 kg is the 99th percentile 1277 male weight as per Adultdata, the Handbook of Adult Anthropometric and Strength 1278 Measurements, by Laura Peebles and Beverley Norris. 110 kg corresponds to 1 078 N, or 1279 approximately 1 100 N. 1280

Explanation of the area load is applied on 1281

For the lateral test, having 2 persons sitting on the side edge of the MEDICAL BED, as close as 1282 possible to the end of the MEDICAL BED is reasonable. Since a 95th percentile male has a hip 1283 breadth, while sitting, of 466 mm [2], the weight of 2 x 1 100 N = 2 200 N is distributed over a 1284 length of 950 mm (466 mm rounded to 475 mm, x 2) and a width of 250 mm as in the previous 1285 edition of this particular standard. For the single person load in the longitudinal test (with fixed 1286 HEAD/FOOT BOARDS), the weight would be distributed over an area of 475 mm x 250 mm and 1287 these loads are placed on each side of the MEDICAL BED since the HEAD/FOOT BOARDS prevents 1288 sitting on the end of the MEDICAL BED. For the longitudinal test where the HEAD/FOOT BOARDS 1289 are removable, the 2 200 N load is placed at the end of the MEDICAL BED and distributed 1290 across the entire width of the MEDICAL BED, which is about 950 mm. 1291

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Testing is done without the SAFE WORKING LOAD, as it is common for visitors to sit on the side 1292 or end of a MEDICAL BED when the PATIENT is NOT in the MEDICAL BED; this is the worst case. 1293 The SAFE WORKING LOAD in place on the MEDICAL BED during the test would only help stabilise 1294 the MEDICAL BED and is therefore not used. The loads specified in the lateral and longitudinal 1295 stability tests should be placed on the side or end of the MEDICAL BED that is heaviest in order 1296 to maximise the potential for tipping, but since it is difficult to determine which side is 1297 heaviest, the test is done on both sides and both ends. 1298

Subclause 201.9.4.3.1 – Instability in transport 1299

The 6-degree angle was determined from Building Code Regulations in different countries. 1300 The maximum angle allowed for floors in Canada 1 in 10 (5,7 degrees), for UK is valid 1301 Building regulations UK 1 in 12 (4,76 degrees), for USA is valid Building regulations USA 1 in 1302 12 (4,76 degrees) and for Denmark is valid Building regulations Denmark 1 in 20 (2,86 1303 degrees). 1304

Subclause 201.9.8.2 – TENSILE SAFETY FACTOR 1305

The safety factor requirements from pre-existing standard IEC 60601-2-38 and EN 1970 were 1306 demonstrated to be sufficient by several years of field application. Consequently these 1307 requirements are carried over in to this particular standard. 1308

Subclause 201.9.8.3.1 – Static forces due to loading from persons 1309

Static strength 1310

EN 1970 was substantially similar to IEC 60601-2-38 in this regard with the exception of the 1311 MEDICAL BED being in the worst-case position. The general standard refers to the worst-case 1312 as the "most disadvantageous" position. The general standard text was therefore chosen, 1313 where "most disadvantageous height" refers to the up/down position of the MEDICAL BED. The 1314 test method requires also most disadvantageous length, as this could be worse case for 1315 MEDICAL BEDS, with build-in or added length adjustment. Additionally, a 1-hour time duration 1316 should be applied only when assemblies contain elements subject to material creep (plastics 1317 or other non-metals). Where all metal assemblies are being tested, timeframes above 1 min 1318 are not needed (see IEC 60601-1, 3rd edition, Clause 9.8.2, Note 2). 1319

ACCESSORIES strength 1320

Terminology of the general standard was adopted. The TENSILE SAFETY FACTOR in 1321 IEC 60601-1, 3rd edition considers wear. Where ACCESSORIES may be cycled to induce similar 1322 wear of components, use of the SAFE WORKING LOAD is acceptable to use to prove compliance 1323 with requirement, provided expected wear is simulated on the ACCESSORY or attachment point 1324 prior to testing. The expected distribution of weight upon the ACCESSORY during reasonably 1325 foreseeable misuse should be considered when testing the ability of the ACCESSORY load 1326 support. 1327

This requirement should only be applied to ACCESSORIES, which could reasonably be expected 1328 to support a PATIENT, during reasonably foreseeable misuse. The 1-hour requirement is only 1329 required in designs where material creep is a concern (plastic parts are used). For assemblies 1330 that are all metal, 1 min is enough to determine if the design is capable of withstanding the 1331 SAFE WORKING LOAD times the TENSILE SAFETY FACTOR (see IEC 60601-1, 3rd, clause 9.8.2 1332 Note 2). 1333

Subclause 201.9.8.3.3 – Dynamic forces due to loading from persons 1334

Loading from persons 1335

These above requirements were added due to issues seen in the field that were perceived to 1336 have been caused by improper specification of dynamic strength. The issues included the 1337 failure of the MEDICAL BED-LIFT assemblies resulting in the MEDICAL BED surface dropping to the 1338 lowest level. It was therefore felt that a minimum standard test should be specified. The 1339

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dynamic strength tests are designed to be a minimum standard to assess the dynamic 1340 strength of the MEDICAL BED (see figure AA.117). Testing should be modified as per the 1341 MANUFACTURER'S RISK ASSESSMENT program based on such things as elimination of RISK by 1342 design, normal and abuse conditions by the OPERATOR or PATIENT, environmental issues and 1343 others. Components, which loosen, or malfunction during tests that do not contribute to 1344 additional RISK, or sudden collapse of product may be replaced. 1345

1346

Figure AA.117 – Other areas of possible impact testing 1347

Subclause 201.9.8.3.3.101 – Dynamic testing of the height adjustment mechanism 1348

The experience of the experts from test houses and MANUFACTURER with the market 1349 observation leads to the result that a dynamic test as described is necessary to provide a 1350 minimum of safety between reasonable service intervals. 1351

Subclause 201.9.8.3.3.102 – SIDE RAIL latch reliability 1352

This requirement combines the proposed cycle test with the load test in IEC 60601-2-38 to 1353 ensure proper latching of the SIDE RAIL after a simulated life cycle. "HAZARD" was changed to 1354 "RISK" to use terminology of IEC 60601-1, 3rd edition. 30 000 cycles is used considering an 1355 average product life cycle of 10 years, with 4 usages per day (14 600 cycles) multiplied by a 1356 safety factor of 2. The number of cycles should be representative of the actual product life 1357 cycle, and product estimated usage of the SIDE RAILS. Components, which loosen, or 1358 malfunction during tests that do not contribute to additional RISK or sudden collapse of SIDE 1359 RAILS, may be replaced. 1360

SIDE RAIL latch 1361

Lateral and longitudinal cycling: The number of cycles chosen is arbitrary in an effort to 1362 reproduce the action of an agitated PATIENT exerting reasonably foreseeable misuse on the 1363 SIDE RAIL. Once again, testing should be tailored to the MANUFACTURER'S indicated life cycle, 1364 estimated SIDE RAIL usage and RISK ANALYSIS with regards to number of cycles, forces applied 1365 and direction of force. 1366

The specified maximum PATIENT weight is used to simulate a PATIENT climbing over the SIDE 1367 RAIL, as an additional reasonably foreseeable misuse. No data has been presented on 1368 PATIENTS over 1 112 N climbing over SIDE RAILS, resulting in a fall. 1369

100 N is selected for this test as an approximation to an agitated PATIENT shaking the SIDE 1370 RAIL from the MEDICAL BED. 1371

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Subclause 201.11.8 – Interruption of power supply/SUPPLY MAINS to ME EQUIPMENT 1372

Examples of emergency procedures (as specified by the MANUFACTURER) that are needed 1373 during an interruption of the power supply/SUPPLY MAINS to MEDICAL BEDS are: 1374

1) Trendelenburg, when specified as an emergency procedure position by the 1375 MANUFACTURER, (the MATTRESS SUPPORT PLATFORM in the flat position, tilting of the entire 1376 MATTRESS SUPPORT PLATFORM a minimum of 12° so that the PATIENT'S head is lower than 1377 the circulatory centre point of the body), 1378

2) Positions for Cardiopulmonary Resuscitation (CPR), for example, Emergency back 1379 flattening, 1380

3) Others as specified by the MANUFACTURER. 1381

Subclause 201.13.1.4 – Specific MECHANICAL HAZARDS 1382

The U.S. Food and Drug Administration incident database was reviewed in the preparation of 1383 this standard to relate field incidents of unintended movement to the concept of SINGLE FAULT 1384 CONDITION and abnormal operation in IEC 60601-1. This review indicates such incidents 1385 mainly manifest when an electrically driven actuation starts unexpectedly and drives to its 1386 limit in one direction. The apparent cause is a fault occurring in MEDICAL BED function controls. 1387

Abnormal operation/fault condition requirements emphasize protection against faults in the 1388 motion control systems of electrically powered MEDICAL BEDS. An interpretation is also 1389 developed to extend the SINGLE FAULT SAFE concept for unintended motion to non-electrically 1390 powered MEDICAL BEDS and pneumatic and hydraulic subsystems of electrical MEDICAL BEDS. 1391

The requirement to provide a means (not accessible by the PATIENT) for deactivating controls 1392 that are accessible by the PATIENT is retained from the previous standard, but regarded as a 1393 human factors aspect that is not inherently integral to SINGLE FAULT CONDITION and abnormal 1394 operation requirements. 1395

Tradeoffs are required among human factors, clinical benefits available from positioning the 1396 MATTRESS SUPPORT PLATFORM, and technology. For instance, it is possible to reduce the 1397 probability of SELF-RUNS by the use of redundant circuits and parallel switches, which have to 1398 be closed simultaneously. Such a requirement is out of proportion to the RISK for the vast 1399 majority of PATIENTS and clinical situations. It would degrade the USABILITY of the product for 1400 clinical users and be equivalent to removing PATIENT controls for those PATIENTS whose lack of 1401 dexterity or medical condition prevents them from operating two controls simultaneously. 1402

This standard introduces the concept of the MOTION LOCKOUT CONTROL. The MOTION LOCKOUT 1403 CONTROL provides a means to reconcile varying PATIENT needs. Some PATIENTS need controls 1404 with a high degree of USABILITY and have little RISK exposure in the event of rare unintended 1405 motion. Other PATIENTS require exceptional protection against possible unintended motion, 1406 even if control ergonomics are entirely sacrificed. A MOTION LOCKOUT CONTROL deployable at 1407 OPERATOR option can meet both needs. 1408

Subclause 201.13.2.2 – Electrical SINGLE FAULT CONDITION 1409

These conditions are defined because IEC 60601-1 does not detail how to interpret single 1410 fault testing except where the HAZARD is fire or electrical shock. 1411

Subclause 201.15.4.4 – Indicators 1412

MEDICAL BEDS connected to MAINS VOLTAGE are generally operational at all times. This is 1413 generally understood by the OPERATORS; therefore no indicator light is required. 1414

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Subclause 201.15.4.6.2 – Limitation of movement 1415

Loss of blood flow to legs (from over-flexing of the torso) or build-up of blood or other fluids in 1416 the abdomen can cause severe damage to PATIENT. 1417

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Annex BB 1418 (informative) 1419

1420 Design recommendations for MEDICAL BEDS 1421

Although it is recognized that the responsibility for defining the INTENDED USE (and therefore 1422 the configuration of features) of the MEDICAL BED rests with the MANUFACTURER, certain factors 1423 should be taken into consideration. The following is intended as a guideline for 1424 MANUFACTURERS when designing MEDICAL BEDS. 1425

BB.1 Strength and durability 1426

It is recognized that MEDICAL BEDS should provide adequate levels of protection from HAZARDS 1427 throughout their EXPECTED SERVICE LIFE. The following tests are presented as guidelines / 1428 possible methods for MANUFACTURERS to use in order to help determine if appropriate levels of 1429 protection are maintained during that period. When used, these tests should be performed in 1430 the sequence in which they are listed. 1431

BB.1.1 The effect of impacts to the MATTRESS SUPPORT PLATFORM 1432

The MEDICAL BED should be able to withstand the effect of impacts to the MATTRESS SUPPORT 1433 PLATFORM being applied during NORMAL USE. 1434


Place the mattress, as specified by the MANUFACTURER, onto the MATTRESS SUPPORT 1436 PLATFORM, in a position in which moving element are free of supporting elements and their 1437 inclination is less than 7° in relation to horizontal, and if height-adjustable, the MATTRESS 1438 SUPPORT PLATFORM shall be placed in the middle of the possible range of the adjustment. 1439

From a height of 180 mm above the MATTRESS SUPPORT PLATFORM, drop the impactor (see 1440 Figure BB.101) onto the MEDICAL BED 20 times onto each of the locations marked “B” in figure 1441 AA.117. The impactor shall be allowed to fall freely, but guides may be used to help insure 1442 that the impacts occur as close as is possible to the recommended locations. 1443

After application of the load, no elements of the MEDICAL BED should become loose, fractured 1444 or present any HAZARD. 1445

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1446

Figure BB.101 – Impactor 1447

The impactor body is approximately 200 mm in diameter and is separated from the striking 1448 surface by helical compression springs. The body is free to move on a line perpendicular to 1449 the plane of the central area of the striking surface. The total mass of the assembly shall be 1450 25 kg ± 0,1 kg and the body and its associated parts (minus the springs) shall have a mass of 1451 17 kg ± 0,1 kg. 1452

The combined spring rate (for the system) shall be 6,9 N/mm ± 1 N/mm and the total friction 1453 resistance of the moving parts is between 0,25 N and 0,45 N. When the spring system is 1454 compressed to a load of 1 040 N ± 5 N, the remaining compression distance shall be 60 mm 1455 minimum. 1456

The striking surface shall be a rigid circular object, (200 ± 5) mm in diameter, the face of 1457 which has a convex spherical curvature of 300 mm radius with a 12 mm front edge radius. 1458

BB.1.2 The effect of loading on the edge of the MATTRESS SUPPORT PLATFORM 1459

The MEDICAL BED should be able to withstand the effect of loading on the edge of the 1460 MATTRESS SUPPORT PLATFORM as being applied during NORMAL USE. 1461


Place the MEDICAL BED in its flat position. If the BED-LIFT is separate from a MATTRESS SUPPORT 1463 PLATFORM, mount a TEST BED BOARD to the BED-LIFT. 1464

Adjust the height to the most adverse position. 1465

Load three loading pads with a load of 750 N each to the MATTRESS SUPPORT PLATFORM to the 1466 locations marked “C” in figure AA.117. 1467

After application of the load, no elements of the BED should become loose, fractured or 1468 present any HAZARD. Deflection (during the application of the load) of less than 40 mm or 1469 deformation of less than 10 mm (after removal of the load) from the corresponding 1470 measurements taken before the application of the load is acceptable. 1471

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BB.1.3 Durability of the moveable sections (if provided) of the MATTRESS SUPPORT 1472 PLATFORM 1473

The moveable sections of the MATTRESS SUPPORT PLATFORM should comply with the following 1474 test: 1475

Apply the SAFE WORKING LOAD distributed as indicated in Figure 116 on the MATTRESS SUPPORT 1476 PLATFORM. 1477

Each of the moveable sections of the MATTRESS SUPPORT PLATFORM are operated through their 1478 full range of travel as in NORMAL USE, a number of times equal to that which the MEDICAL BED 1479 would experience during its anticipated useful life. 1480

A minimum of 1 000 cycles is recommended. 1481

Inspect the MEDICAL BED 5 minutes after cycling is completed. 1482

After application of the load, no elements of the MEDICAL BED should become loose, fractured 1483 or present any HAZARD and deformation of less than 10 mm (after removal of the load) from 1484 the corresponding measurements taken before the application of the load is acceptable. 1485

BB.2 Human factors (ergonomy) 1486

It is recognized that for MEDICAL BEDS to accommodate the medical practices and procedures 1487 for which it will be used, the interaction of the human body with the ME EQUIPMENT should be 1488 considered as a method of assuring efficient and safe operation. The following is presented 1489 for consideration when addressing these issues. It should be noted however that the following 1490 may not be the only way to address the issues and that any dimensions are based on 1491 statistical analyses of regional populations. When used, appropriate dimensions should 1492 always be determined based on anthropometric data for the population in the area in which 1493 the MEDICAL BED is intended to be used. 1494

BB.2.1 Range of adjustment of the height of the MATTRESS SUPPORT PLATFORM 1495

Recommended range of adjustment (if applicable) of the height of the MATTRESS SUPPORT 1496 PLATFORM above the floor: 1497

The MATTRESS SUPPORT PLATFORM, in its flat position should have a range of adjustment, 1498 which at least allows positioning between 400 mm and 800 mm above the floor, measured at 1499 the upper most part of the MATTRESS SUPPORT PLATFORM. 1500

MEDICAL BEDS without the possibility of adjustment of height are only suitable for persons not 1501 needing caregivers. 1502

BB.2.2 Dimensions for handles and pedals 1503

BB.2.2.1 All handles and pedals should be reachable from normal working positions and 1504 be placed so they allow operations to be carried out in a safe and ergonomic manner. 1505

BB.2.2.2 Location and configuration of all buttons / switches / actuators should minimize 1506 the RISK of unintentional activation. 1507

BB.2.2.3 The surface of buttons should at least cover a circle of 15 mm in diameter. Any 1508 distance between buttons should be more than 10 mm. 1509

The buttons may have any shape, e.g. they need not to be circular. 1510

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BB.2.2.4 The free distance between any handle (those parts intended to be grabbed) 1511 requiring an operating force of more than 10 N and any construction part should be more than 1512 35 mm. 1513

BB.2.2.5 The free distance between the upper side of any pedal (those parts intended to 1514 be stepped on) and any construction part should be more than 75 mm. 1515

BB.2.2.6 The diameter of operating handles requiring an operating force of more than 1516 10 N should be between 19 mm and 43 mm. 1517

BB.2.2.7 Pedals should not be more than 300 mm above the floor. 1518

BB.2.3 Operating forces for handles and pedals 1519

BB.2.3.1 In the case of electrically operated functions, the force to operate the control 1520 unit buttons should be less than 5 N. 1521

BB.2.3.2 In the case of non-electrically operated functions, the force to release 1522 operating handles should be no more than 10 N and the force required to lift any part of the 1523 MATTRESS SUPPORT PLATFORM should be no more than 200 N, when loads are fixed to the 1524 MATTRESS SUPPORT PLATFORM as shown in Figure 116, with their centre of gravity in the middle 1525 of the sections. 1526

BB.2.3.3 The static force to operate pedals should be no more than 300 N when loads 1527 are fixed to the MATTRESS SUPPORT PLATFORM, as shown in Figure 116, with their centre of 1528 gravity in the middle of the sections. 1529

BB.2.3.4 For MOBILE MEDICAL BEDS intended to transport PATIENTS, the force required to 1530 initiate movement of the MEDICAL BED with the SAFE WORKING LOAD should not exceed 160 N. 1531 The force required to maintain movement (after it has been initiated) should not exceed 85 N. 1532

BB.3 Functionality 1533

Frequently, MEDICAL BEDS are designed for use in combination with other ME EQUIPMENT. 1534 MANUFACTURERS are encouraged to evaluate not only those characteristics of the MEDICAL BED 1535 that could affect the safe operation of the system (the MEDICAL BED in combination with the 1536 ME EQUIPMENT) but also the characteristics of the MEDICAL BED, WHICH facilitate the use of the 1537 system. 1538

BB.3.1 Combination of MEDICAL BED and MOBILE hoists 1539

With the MATTRESS SUPPORT PLATFORM lowered to any position higher than 400 mm, the height 1540 of the under MEDICAL BED clearance should be at least 150 mm at a length of at least 500 mm 1541 positioned on each side of the symmetry plane of the MATTRESS SUPPORT PLATFORM (see figure 1542 BB.102) 1543

1544

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1545

Figure BB.102 – Schematic presentation of under MEDICAL BED clearance 1546

BB.3.2 Combination of MEDICAL BED and mattress 1547

At the seat section of the MATTRESS SUPPORT PLATFORM, the height of the mattress used 1548 should at least be 20 mm higher than any construction part e.g. MEDICAL BED frame, side 1549 structure or the lowered SIDE RAILS in any position of the MATTRESS SUPPORT PLATFORM. 1550

BB.3.3 Range of adjustment of moveable sections of the MATTRESS SUPPORT platform 1551

Recommended range of adjustment (if applicable) for back, upper leg, and lower leg sections 1552 of the MATTRESS SUPPORT PLATFORM: 1553

– The angle A between the back rest section and the MEDICAL BED board frame (see 1554 Figure BB.103) should at least be adjustable within the range of 0° (horizontal) and 70°. A 1555 maximum of 85° should only be reachable when the MEDICAL BED is intended to raise a 1556 person to an upright sitting position for transfer. 1557

– The angle B between a line drawn between the turning point of the back rest section/seat 1558 section and the turning point of the upper/lower leg section and horizontal (see Figure 1559 BB.103) should at least be adjustable between 0° and 12°. 1560

– The angle C between the back rest section and a line draw between the turning point of 1561 the back rest section/seat section and the turning point of the upper/lower leg section (see 1562 revised Figure BB.103) shall be greater than 90° (as in 15.4.6.2). 1563

– The angle D between the lower leg section and horizontal (see Figure BB.103) should at 1564 least be adjustable between 0° and 20° under horizontal. 1565

– The angle E between the upper side of the upper leg section and the upper side of the 1566 lower leg section (see Figure BB.103) should be at least 180°. 1567

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1568

1569

1570

1571

1572

1573

1574

Figure BB.103 – Recommended angles for different sections of the MATTRESS SUPPORT 1575 PLATFORM 1576

1577

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Bibliography 1578

[1] DIN VDE 0207-20 Isolier- und Mantelmischungen für Kabel und isolierte Leitungen 1579 [2] People Size, 1998 1580

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Index of defined terms used in this particular standard 1581

ACCESSORIES........................................................................................ IEC 60601-1:2005, 3.3 1582 APPLICATION ENVIRONMENT 1..................................................................................... 201.3.201 1583 APPLICATION ENVIRONMENT 2..................................................................................... 201.3.202 1584 APPLICATION ENVIRONMENT 3..................................................................................... 201.3.203 1585 APPLICATION ENVIRONMENT 4..................................................................................... 201.3.204 1586 APPLICATION ENVIRONMENT 5..................................................................................... 201.3.205 1587 APPLIED PART............................................................................................................... 201.3.8 1588 BASIC SAFETY.......................................................................................IEC 60601-1:2005, 3.10 1589 BED-LIFT .................................................................................................................. 201.3.206 1590 CLASS II...............................................................................................IEC 60601-1:2005, 3.14 1591 COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS ............................ IEC 60601-1:2005, 3-17 1592 DISABLED PERSON..................................................................................................... 201.3.207 1593 ENCLOSURES .......................................................................................IEC 60601-1:2005, 3.26 1594 ESSENTIAL PERFORMANCE .....................................................................IEC 60601-1:2005, 3.27 1595 EXPECTED SERVICE LIFE ........................................................................IEC 60601-1:2005, 3.28 1596 FUNCTIONAL CONNECTION ......................................................................IEC 60601-1:2005, 3.33 1597 HAZARD ...............................................................................................IEC 60601-1:2005, 3.39 1598 HAZARDOUS SITUATION ..........................................................................IEC 60601-1:2005, 3.40 1599 HEAD/FOOT BOARD .................................................................................................... 201.3.208 1600 HOLD-TO-RUN-CONTROL ............................................................................................ 201.3.209 1601 INTENDED USE ......................................................................................IEC 60601-1:2005, 3.44 1602 LEAKAGE CURRENT................................................................................IEC 60601-1:2005, 3.47 1603 LIFTING POLE............................................................................................................ 201.3.210 1604 MAINS VOLTAGE ...................................................................................IEC 60601-1:2005, 3.54 1605 MANUFACTURER....................................................................................IEC 60601-1:2005, 3.55 1606 MATTRESS OVERLAY .................................................................................................. 201.3.211 1607 MATTRESS SUPPORT PLATFORM .................................................................................. 201.3.212 1608 MECHANICAL HAZARDS...........................................................................IEC 60601-1:2005, 3.61 1609 MECHANICAL PROTECTIVE DEVICES..........................................................IEC 60601-1:2005, 3.62 1610 MEDICAL BED............................................................................................................ 201.3.213 1611 MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) .................................. IEC 60601-1:2005, 3.63 1612 MEDICAL ELECTRICAL SYSTEM (ME SYSTEM) ............................................ IEC 60601-1:2005, 3.64 1613 MOBILE ................................................................................................IEC 60601-1:2005, 3.65 1614 MODEL OR TYPE REFERENCE ..................................................................IEC 60601-1:2005, 3.66 1615 MOTION LOCKOUT CONTROL........................................................................................ 201.3.214 1616 NORMAL USE ........................................................................................IEC 60601-1:2005, 3.71 1617 OPERATOR ...........................................................................................IEC 60601-1:2005, 3.73 1618 PATIENT..................................................................................................................... 201.3.76 1619 PENDANT CONTROL ................................................................................................... 201.3.215 1620 POWER SUPPLY CORD ............................................................................IEC 60601-1:2005, 3.87 1621 PROCESS .............................................................................................IEC 60601-1:2005, 3.89 1622 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................IEC 60601-1:2005, 3.90 1623

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RESPONSIBLE ORGANIZATION ............................................................... IEC 60601-1:2005, 3.101 1624 RISK .................................................................................................. IEC 60601-1:2005, 3.102 1625 RISK ANALYSIS.................................................................................... IEC 60601-1:2005, 3.103 1626 RISK ASSESSMENT............................................................................... IEC 60601-1:2005, 3.104 1627 RISK MANAGEMENT FILE ....................................................................... IEC 60601-1:2005, 3.108 1628 SAFE WORKING LOAD .......................................................................... IEC 60601-1:2005, 3.109 1629 SELF-RUN ................................................................................................................ 201.3.216 1630 SIDE RAIL ................................................................................................................. 201.3.217 1631 SINGLE FAULT CONDITION..................................................................... IEC 60601-1:2005, 3.116 1632 SPECIALTY MATTRESS................................................................................................ 201.3.218 1633 SUPPLY MAINS .................................................................................... IEC 60601-1:2005, 3.120 1634 TENSILE SAFETY FACTOR...................................................................... IEC 60601-1:2005, 3.121 1635 TEST BED BOARD....................................................................................................... 201.3.219 1636 TOOL ................................................................................................. IEC 60601-1:2005, 3.127 1637 TRAPPING ZONE ........................................................................................................ 201.3.131 1638 UNDERCARRIAGE ...................................................................................................... 201.3.220 1639 USABILITY .......................................................................................... IEC 60601-1:2005, 3.136 1640

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