FprEN IEC 80601-2-52:2025

SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-52:2024
01-maj-2024
Medicinska električna oprema - 2-52. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih postelj
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and
essential performance of medical beds
Appareil électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et de
performances essentielles des lits médicaux
Ta slovenski standard je istoveten z: prEN IEC 80601-2-52:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 80601-2-52:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN IEC 80601-2-52:2024

oSIST prEN IEC 80601-2-52:2024
62D/2114/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-52 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-03-01 2024-05-24
SUPERSEDES DOCUMENTS:
62D/1759A/CD, 62D/1782A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential
performance of medical beds
PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

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1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 8
4 201.1 Scope, object and related standards . 9
5 201.2 Normative references . 11
6 201.3 Terms and definitions . 11
7 201.4 General requirements . 15
8 201.5 General requirements for testing of ME EQUIPMENT . 15
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
10 201.7 ME EQUIPMENT identification, marking and documents . 18
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 24
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 25
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 50
14 201.11 Protection against excessive temperatures and other HAZARDS . 50
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 53
17 201.13 HAZARDOUS SITUATIONS and fault conditions . 54
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 54
19 201.15 Construction of ME EQUIPMENT . 55
20 201.16 ME SYSTEMS . 59
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 59
22 Annexes. 59
23 Annex AA (informative) Particular guidance and rationale . 60
24 Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS . 76
25 Annex CC (informative) Particular guidance for assessing risk of entrapment in v -
26 shaped openings . 80
27 Annex DD (informative) Guidance and recommendations for periodic inspection . 86
28 Bibliography . 88
29 Index of defined terms used in this particular standard . 89
31 FIGURES
32 Figure 201.101 – MEDICAL BED, general arrangement . 14
33 Figure 201.102 – Entrapment test tools . 16
34 Figure 201.103 – Loading pad . 17
35 Figure 201.104 – Impactor . 17
36 Figure 201.105 – Ball chain loop and spherical mass . 18
37 Figure 201.106 – Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD . 19
38 Figure 201.107 – Graphic symbol for mass; weight . 19
39 Figure 201.108 – Graphic symbol for machine washable MEDICAL BED . 19
40 Figure 201.109 – Graphic symbol for jet stream washable MEDICAL BED . 20
41 Figure 201.110 – Graphic symbol for manual cleaning only . 20
42 Figure 201.111 – Physical description of an ADULT . 21

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43 Figure 201.112 – MEDICAL BED function controls and/or actuators: guidelines for
44 creating graphical symbols . 22
45 Figure 201.113 – Example of MEDICAL BED with segmented or split SIDE RAIL . 26
46 Figure 201.114 – Example of MEDICAL BED with single piece SIDE RAIL . 27
47 Figure 201.115 – Allowable spacing for fingers in areas of normal reach around the
48 perimeter of the MATTRESS SUPPORT PLATFORM . 32
49 Figure 201.116 – Example using barriers for clearance measurement around the
50 perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT finger entrapment . 33
51 Figure 201.117 – Clearance areas . 34
52 Figure 201.118 – Retention of loop and mass . 36
53 Figure 201.119 – Lateral stability test along the side of the MEDICAL BED . 38
54 Figure 201.120 – Longitudinal stability test with removable FOOT BOARD . 38
55 Figure 201.121 – Longitudinal stability test with fixed HEAD/FOOT BOARD . 39
56 Figure 201.122 – Distribution of SAFE WORKING LOAD / maximum PATIENT weight for tests . 42
57 Figure 201.123 – Position of Dynamic loading (see Figure 201.103 for loading pad) . 45
58 Figure 201.124 – Application of forces for test of SIDE RAIL . 46
59 Figure 201.125 – Height of SIDE RAIL . 49
60 Figure 201.126 Direction of movement for rough handling test . 55
61 Figure 201.127 – Configurations of the MATTRESS SUPPORT PLATFORM . 57
62 Figure AA.1 – Example of marking to select recommended mattresses specified by the
63 MANUFACTURER . 62
64 Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the
65 MANUFACTURER . 63
66 Figure AA.3 – Examples of marking on the MEDICAL BED of storage location for wired
67 and wireless PENDANT CONTROLS . 63
68 Figure AA.4 – Resultant forces without mattress . 66
69 Figure AA.5 – Resultant forces with mattress . 66
70 Figure AA.6 – Example of 60 mm gap measurement of B . 66
71 Figure AA.7 – Angle measurement example of B . 66
72 Figure AA.8 – Placement of measurement TOOL for measurement of D . 68
73 Figure AA.9 – Example of area D measurement that passes . 68
74 Figure AA.10 – Example of area D measurement that fails (on limit) . 68
75 Figure AA.11 – Example of area D measurement that fails . 68
76 Figure AA.12 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 69
77 Figure AA.13 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 69
78 Figure AA.14 – Example of potential PATIENT entrapment in area B . 69
79 Figure AA.15 – Example of potential PATIENT entrapment in area C between split SIDE
80 RAIL . 69
81 Figure AA.16 – Example of potential PATIENT entrapment in area C between SIDE RAIL
82 and HEAD BOARD . 69
83 Figure AA.17 – Example of potential PATIENT entrapment in area D . 69
84 Figure AA.18 – Example of potential PATIENT entrapment in area A below a single piece
85 SIDE RAIL . 69
86 Figure AA.19 – Concept of potential PATIENT foot-first entrapment tool for area A below
87 a single piece SIDE RAIL . 70
88 Figure BB.1 – Schematic presentation of under MEDICAL BED clearance . 78

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89 Figure BB.2 – Recommendations and requirements regarding angles for different
90 sections of the MATTRESS SUPPORT PLATFORM . 79
91 Figure CC.1 – Wedge tool . 81
92 Figure CC.2 – V-shaped opening in relation to B . 82
93 Figure CC.3 – Pass/fail in relation to area B . 83
94 Figure CC.4 – Positioning of wedge tool . 84
95 Figure CC.5 – Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD . 84
96 Figure CC.6 – Pass/fail in relation to area C between split SIDE RAILS . 85
98 TABLES
99 Table 201.101 – Protection against PATIENT entrapment . 28
100 Table 201.102 – Protection against inadvertent PATIENT falls . 50
101 Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED
102 PARTS . 51
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104 INTERNATIONAL ELECTROTECHNICAL COMMISSION
105 ____________
107 MEDICAL ELECTRICAL EQUIPMENT –
109 Part 2-52: Particular requirements for the basic safety
110 and essential performance of medical beds for adults
113 FOREWORD
114 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
115 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
116 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
117 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
118 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
119 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
120 in the subject dealt with may participate in this preparatory work. International, governmental and non-
121 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
122 with the International Organization for Standardization (ISO) in accordance with conditions dete rmined by
123 agreement between the two organizations.
124 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
125 consensus of opinion on the relevant subjects since each technical committee has represent ation from all
126 interested IEC National Committees.
127 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
128 Committees in that sense. While all reasonable efforts are made to ensure that the technical con tent of IEC
129 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
130 misinterpretation by any end user.
131 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publicatio ns
132 transparently to the maximum extent possible in their national and regional publications. Any di vergence
133 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
134 the latter.
135 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
136 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
137 services carried out by independent certification bodies.
138 6) All users should ensure that they have the latest edition of this publication.
139 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
140 members of its technical committees and IEC National Committees for any personal injury, property damage or
141 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
142 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any othe r IEC
143 Publications.
144 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
145 indispensable for the correct application of this publication.
146 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
147 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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149 International standard IEC 80601-2-52 has been prepared by IEC subcommittee 62D:
150 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
151 practice, and by ISO technical committee 173: Assistive products for persons with disability.
152 It is published as double logo standard.
153 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
154 In this standard, the following print types are used:
155 – Requirements and definitions: roman type.
156 – Test specifications: italic type.
157 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
158 Normative text of tables is also in a smaller type.
159 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
160 NOTED: SMALL CAPITALS.
161 In referring to the structure of this standard, the term
162 – “clause” means one of the seventeen numbered divisions within the table of contents,
163 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
164 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
165 subclauses of Clause 7).
166 References to clauses within this standard are preceded by the term “Clause” followed by the
167 clause number. References to subclauses within this collateral standard are by number only.
168 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
169 combination of the conditions is true.
170 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
171 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
172 – “shall” means that compliance with a requirement or a test is mandatory for compliance
173 with this standard;
174 – “should” means that compliance with a requirement or a test is recommended but is not
175 mandatory for compliance with this standard;
176 – “may” is used to describe a permissible way to achieve compliance with a requirement or
177 test.
178 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
179 indicates that there is guidance or rationale related to that item in Annex AA.
180 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
181 equipment, can be found on the IEC website.
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183 The committee has decided that the contents of the base publication and its amendment will
184 remain unchanged until the stability date indicated on the IEC web site under
185 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
186 publication will be
187 • reconfirmed,
188 • withdrawn,
189 • replaced by a revised edition, or
190 • amended.
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192 INTRODUCTION
193 In 1996, the IEC published the first edition of the particular standard for electrically operated
194 hospital beds, IEC 60601-2-38. The publication was in response to demand in the field for a
195 universal standard addressing HAZARDS specific to the safety of the hospital bed. Used in
196 conjunction with a MANUFACTURER’S RISK ASSESSMENT, the standard was felt to be the current
197 thinking on establishing a basic safety benchmark for industry.
198 An amendment of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a
199 RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the
200 MANUFACTURER’S RISK ASSESSMENT. Although this improved the particular standard, it still was
201 centered upon electrically operated hospital beds, and failed to take into account manu ally
202 operated hospital beds and products in other medical environments.
203 In 2000, the EN 1970 standard (Adjustable beds for DISABLED PERSONS – Requirements and
204 test methods) was published, which addressed beds used by PERSONS WITH DISABILITY to
205 alleviate or compensate for a disability or handicap. This standard offered a broadened scope
206 in conjunction with IEC 60601-2-38, but after the edition of Amendment 1 to IEC 60601-2-38,
207 the opportunity presented itself to combine the two standards to a common, interna tional
208 standard.
209 As work began on the integration, the IEC adjusted its stance on BASIC SAFETY and ESSENTIAL
210 PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became
211 necessary to align the new standard with the third edition. The particular standard was given a
212 new number, IEC 60601-2-52, and work began on alignment to third edition.
213 This particular standard, therefore, is the realization of much work in alignment, and scope
214 adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It
215 represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL
216 BED as used to alleviate illness of PATIENTS and disability of PERSONS WITH DISABILITY. This is
217 the effort of a joint working group of the IEC and the ISO.
218 IEC 80601-2-52 is a continuation of the IEC 60601-2-52 standard. It will align with the
219 CHILDREN version of the standard, IEC 80601-2-89. The standard number was changed from
220 IEC 60601-2-52 to IEC 80601-2-52 to indicate joint work between the ISO and the IEC.
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222 MEDICAL ELECTRICAL EQUIPMENT –
224 Part 2-52: Particular requirements for the basic safety
225 and essential performance of medical beds for adults
228 201.1 Scope, object and related standards
1)
229 Clause 1 of the general standard applies, except as follows:
230 201.1.1 * Scope
231 Replacement:
232 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
233 MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included
234 in scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without
235 adjustable features.
236 This standard does not apply for MEDICAL BEDS intended for CHILDREN covered by IEC 80601-
237 2-89 Medical electrical equipment – Particular requirements for the basic safety and essential
238 performance of medical beds for children.
239 A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible
240 non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
241 Excluded are devices for which the intended use is mainly for examination or transportation
242 under medical supervision (e.g. stretcher, examination table).
243 This standard does not apply in all requirements to MEDICAL BEDS with special functionality.
244 Beds that are intended to be used for ADULTS with atypical anatomy shall state what atypical
245 anatomies are meant. Additional requirements for the stated atypical anatomies shall be
246 determined in the product RISK MANAGEMENT process and implemented as appropriate in the
247 bed design.
248 EXAMPLE A bed intended for bariatric PATIENTS would require consideration of the differences in anthropomorphic
249 ranges, and having implemented those ranges would label appropriately for the intended PATIENT population.
250 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to
251 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
252 case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
253 HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within
254 the scope of this standard are not covered by specific requirements in this standard except in
255 7.2.13 and 8.4.1 of the general standard.
256 NOTE See also 4.2 of the general standard.
257 201.1.2 Object
258 Replacement:
—————————
1)
The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.

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259 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
260 PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as
261 defined in 201.3.222.
262 201.1.3 Collateral standards
263 Addition:
264 This particular standard refers to those applicable collateral standards that are listed in
265 Clause 2 of the general standard and Clause 2 of this particular standard.
266 IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
267 the IEC 60601-1 series apply as published.
268 Some IEC 60601-1-8 requirements may be excluded if they don’t affect PATIENT safety, could
269 lead to user confusion, or are inappropriate to MEDICAL BED usage.
270 Compliance is checked by inspection of the RISK MANAGEMENT FILE and USABILITY ENGINEERING
271 FILE.
272 201.1.4 Particular standards
273 Replacement:
274 In the IEC 60601 series, particular standards may modify, replace or delete requirements
275 contained in the general standard and collateral standards as appropriate for the particular
276 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
277 PERFORMANCE requirements.
278 A requirement of a particular standard takes priority over the general standard.
279 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
280 Collateral standards are referred to by their document number.
281 The numbering of clauses and subclauses of this particular standard corresponds to that of
282 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
283 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
284 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
285 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
286 standard, 203.4 in this particular standard addresses the content of Clause 4 of the
287 IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
288 specified by the use of the following words:
289 "Replacement" means that the clause or subclause of the general standard or applicable
290 collateral standard is replaced completely by the text of this particular standard.
291 "Addition" means that the text of this particular standard is additional to the requirements of
292 the general standard or applicable collateral standard.
293 "Amendment" means that the clause or subclause of the general standard or applicable
294 collateral standard is amended as indicated by the text of this particular standard.
295 Subclauses, figures or tables which are additional to those of the general standard are
296 numbered starting from 201.101. However, due to the fact that definitions in the general
297 standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered
298 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
299 aa), bb), etc.
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300 Subclauses, figures or tables which are additional to those of a collateral standard are
301 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
302 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
303 The term "this standard" is used to make reference to the general standard, any applicable
304 collateral standards and this particular standard taken together.
305 Where there is no corresponding clause or subclause in this particular standard, the clause or
306 subclause of the general standard or applicable collateral standard, although possibly not
307 relevant, applies without modification; where it is intended that any part of the general
308 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
309 statement to that effect is given in this particular standard.
310 201.2 Normative references
311 NOTE Informative references are listed in the bibliography on page 86.
312 Clause 2 of the general standard applies except as follows:
313 Replacement:
314 Change IEC 60529 reference from Amendment 1 to Amendment 2:
315 IEC 60529:1989+AMD1:1999+AMD2:2013 CSV, Degrees of protection provided by enclosures (IP
316 Code)
317 Additions:
318 EN 597-1 Furniture – Assessment of the ignitability of mattresses and upholstered bed bases
319 – Part 1. Ignition source: smouldering cigarette
320 EN 597-2 Furniture – Assessment of the ignitability of mattresses and upholstered bed bases
321 – Part 2. Ignition source: match-flame equivalent
322 IEC 60068-2-31 Environmental testing – Part 2-31: Tests – Test Ec: Rough handling shocks,
323 primarily for equipment-type specimens
324 201.3 Terms and definitions
325 For the purposes of this document, the terms and definitions given in the general standard
326 apply, except as follows:
327 NOTE An index of defined terms is found beginning on page 89.
328 201.3.76
329 PATIENT
330 Replacement:
331 person undergoing a medical procedure or PERSON WITH DISABILITY
332 201.3.109
333 SAFE WORKING LOAD
334 SWL
335 Replacement:
336 The SAFE WORKING LOAD is the sum of:

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337 1) the PATIENT;
338 2) the mattress;
339 3) the ACCESSORIES of the MEDICAL BED, only if they are supported by the support system
340 of the MEDICAL BED; and
341 4) the SAFE WORKING LOADS supported by those ACCESSORIES, excluding PATIENT weight.
342 201.3.131
343 * TRAPPING ZONE
344 Addition:
345 locations where the body of a MEDICAL BED occupant can become entrapped, entangled,
346 wedged, or stuck in or between parts of the MEDICAL BED, such as the SIDE RAILS, HEAD/FOOT
347 BOARD, MATTRESS SUPPORT PLATFORM or mattress
348 Addition:
349 201.3.201
350 * APPLICATION ENVIRONMENT 1
351 intensive/critical care provided in a hospital where 24 h medical supervision and constant
352 monitoring is required and provision of life support system/equipment used in medical
353 procedures is essential to maintain or improve the vital functions of the PATIENT
354 201.3.202
355 * APPLICATION ENVIRONMENT 2
356 acute care provided in a hospital or other medical facility where medical supervision and
357 monitoring is required and ME EQUIPMENT used in medical procedures is often provided to help
358 maintain or improve the condition of the PATIENT
359 201.3.203
360 * APPLICATION ENVIRONMENT 3
361 long-term care in a medical area where medical supervision is required and monitoring is
362 provided if necessary and ME EQUIPMENT used in medical procedures may be provided to help
363 maintain or improve the condition of the PATIENT
364 NOTE 1 to entry This includes use in nursing homes and in rehabilitation and geriatric facilities.
365 201.3.204
366 * APPLICATION ENVIRONMENT 4
367 care provided in a domestic area where ME EQUIPMENT is used to alleviate or compensate for
368 an injury, disability or disease
369 NOTE 1 to entry: This excludes use in all other APPLICATION ENVIRONMENTs (e.g. nursing homes, rehabilitation and
370 geriatric facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.
371 201.3.205
372 * APPLICATION ENVIRONMENT 5
373 outpatient (ambulatory) care, which is provided in a hospital or other medical facility, under
374 medical supervision where ME EQUIPMENT, is provided for the need of persons with illness,
375 injury or disability for treatment, diagnosis or monitoring
376 201.3.206
377 * APPLICATION ENVIRONMENT 6
378 Psychiatric (mental health) care environment where medical supervision is required, and
379 monitoring is provided. ME EQUIPMENT used in medical procedures may be provided to help
380 maintain, improve condition and protect the PATIENT. Environment where a PATIENT may be a
381 harm to themselves or others.
382 NOTE 1 to entry: Includes prisons, jails, correctional facilities.

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383 201.3.207
384 BED-LIFT
385 height adjusta:ble mechanism on which a MATTRESS SUPPORT PLATFORM can be mounted
386 NOTE 1 to entry The combination of a BED LIFT and a compatible non-MEDICAL BED as specified by the
387 MANUFACTURER is considered to be a MEDICAL BED.
388 201.3.208
389 CHILD
390 PATIENT having a body length equal to or less than 155 cm and a mass equal to or less than
391 70 kg and may display cognitive immaturity, exploratory behaviours and/or risk-taking
392 tendencies
393 [IEC 80601-2-89, 201.3.207]
394 201.3.209
395 PERSON WITH DISABILITY
396 person with one or more impairments, one or more activity limitations, one or more
397 participation restrictions or a combination thereof
398 [ISO 9999:2016]
399 201.3.210
400 HEAD/FOOT BOARD
401 assembly/assemblies mounted to MEDICAL BED, which identifies for the PATIENT the edge of the
402 head or foot end of the MEDICAL BED and/or MATTRESS SUPPORT PLATFORM
403 NOTE 1 to entry: It may be used as handles to push a MEDICAL BED intended to transport PATIENTS.
404 201.3.211
405 LIFTING POLE
406 ACCESSORY attached to a MEDICAL BED and intended to assist support of a PATIENT when
407 changing position by providing a gripping support above the PATIENT
408 201.3.212
409 MATTRESS OVERLAY
410 supplementary mattress (support surface), which is intended to be placed on an existing
411 mattress, and generally used for prophylactic or therapeutic effect
412 201.3.213
413 MATTRESS SUPPORT PLATFORM
414 structure which supports a PATIENT surface (for example mattress)
415 NOTE 1 to entry: It can articulate or change positions to facilitate various therapeutic, diagnostic and convenience
416 positions (See Figures 201.101 and 201.127 a) to 201.127 d)).

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Key
1 HEAD BOARD
2 Back section
3 Seat section
4 Upper leg section
5 Lower leg section
6 FOOT BOARD
417 Figure 201.101 – MEDICAL BED, general arrangement
418 (example, schematic presentation only)
419 201.3.214
420 * MEDICAL BED
421 device for which the INTENDED USE is sleeping/resting that contains a MATTRESS SUPPORT
422 PLATFORM and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of
423 disease or compensation for an injury or handicap
424 201.3.215
425 MOTION LOCKOUT CONTROL
426 auxiliary subsystem that deactivates motion controls
427 201.3.216
428 PENDANT CONTROL
429 handheld device provided by the MANUFACTURER, which has a FUNCTIONAL CONNECTION to the
430 MEDICAL BED, controlling at least MEDICAL BED articulations and/or movements
431 NOTE 1 to entry: PENDANT CONTROLS may be wired, or wireless, and may integrate other functions, (e.g.
432 communications, radio/tv, etc.).
433 201.3.217
434 SIDE RAIL
435 physical barrier, which may be a detachable ACCESSORY or integral to the overall construction
436 of a MEDICAL BED and is mounted to the side(s) of the MEDICAL BED
437 NOTE 1 to entry: When a SIDE RAIL is located in the “up” position it provides a physical barrier, which is intended
438 to reduce the RISK of the PATIENT accidentally slipping or rolling off the mattress.
439 201.3.218
440 SPECIALTY MATTRESS
441 mattress intended for prophylactic or therapeutic effect
442 201.3.219
443 TEST BED BOARD
444 flat, rigid loading board of dimensions as specified by the MANUFACTURER representing the
445 dimensions of the MEDICAL BED

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446 201.3.220
447 TRENDELENBURG
448 A specific therapeutic position used in some medical procedures requiring a minimum 12°
449 head down angle of the entire mattress support platform with respect to horizontal.
450 201.3.221
451 UNDERCARRIAGE
452 all components of the MEDICAL BED or BED-LIFT below the MATTRESS SUPPORT PLATFORM
453 201.3.222
454 * ADULT
455 PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than 40
456 kg and a body mass index (BMI) equal to or more than 17, or having a physical size, mass,
457 and body index as defined by the MANUFACTURER’S RISK MANAGEMENT FILE
458 201.4 General requirements
459 Clause 4 of the general standard applies.
460 201.4.2.2 * General requirement for RISK MANAGEMENT
461 Addition:
462 The MANUFACTURER shall include, in the RISK MANAGEMENT process, HAZARDS related to
463 PATIENTS taller than 185 cm, or having a physical size, mass and body mass index (BMI)
464 outside the definition of ADULT.
465 Any alternative means not described in this standard to ensure an equivalent level of BASIC
466 SAFETY and ESSENTIAL PERFORMANCE shall be justified by the MANUFACTURER in the RISK
467 MANAGEMENT FILE.
468 For medical beds intended for application enviroment 6 the risk management shall include:
469 • Strangulation hazards
470 • Snagging hazards
Disassembly resulting in chocking and /or ingestion
471 •
Material flammability
472 •
473 Compliance is checked by inspection of the RISK MANAGEMENT FILE.
474 201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
475 Addition:
476 All parts within the reach of the PATIENT, even if they are underneath the MATTRESS SUPPORT
477 SURFACE (see Figure 201.116) shall be included in the RISK MANAGEMENT process for
478 determination if they should be treated as APPLIED PARTS.
479 For APPLICATION ENVIRONMENT 4 and APPLICATION ENVIRONMENT 6, APPLIED PARTS shall include
480 all parts of the MEDICAL BED (the entire bed).
481 201.5 General requirements for testing of ME EQUIPMENT
482 Clause 5 of the general standard applies, except as follows:
483 Additional subclauses:
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484 201.5.101 * Entrapment test tools
485 Figures 201.102 a) and 201.102 b) illustrate entrapment test tools (a cone tool and a cylinder
486 tool respectively).
487 Dimensions in millimeters
488 Total weight 5,13 kg ±0,05 kg
490 Key
491 1 Marked centre line
492 2 Drilling hole for weight adjustment, if necessary
493 Figure 201.102 a) – Cone tool schematic
494 Dimensions in millimeters
495 Total weight 3,34 kg ±0,05 k
497 Key
498 1 Drilling hole for weight adjustment, if necessary
499 Figure 201.102 b) – Cylinder tool schematic
500 Figure 201.102 – Entrapment test tools

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501 201.5.102 Loading pad
502 The loading pad (see Figure 201.103) is a rigid circular object, (355 +/– 5) mm in diameter,
503 the face of which has a convex spherical curvature of 800 mm radius with a 20 mm front edge
504 radius.
505 Dimensions in millimeters
507 Figure 201.103 – Loading pad
508 201.5.103 Impactor
509 The impactor body is approximately 200 mm in diameter and is mounted to the striking
510 surface. The total mass of the assembly shall be 25 kg  0,1 kg.
511 The striking surface shall be a rigid circular object, (200  5) mm in diameter, the face of
512 which has a convex spherical curvature of 300 mm radius with a 12 mm front edge radius.
514 Key
515 1 connecting part of the lifting device which shall not restrain the free fall
516 2 striking surface
517 Figure 201.104 – Impactor
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518 Dimensions in millimeters
520 Key
521 1 ball chain loop with a length of 200 ± 2 mm
522 2 spherical mass, weight 2,5 ± 0,05 kg and diameter 115 ± 1 mm
523 3 fixing point
524 NOTE The ball chain loop is formed by the ball chain entering the spherical mass at a common fixing point.
525 Figure 201.105 – Ball chain loop and spherical mass
526 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
527 Clause 6 of the general standard applies, except as follows:
528 201.6.2 * Protection against electrical shock
529 Addition:
530 For APPLICATION ENVIRONMENT 4, the MEDICAL BED shall be CLASS II.
531 201.7 ME EQUIPMENT identification, marking and documents
532 Clause 7 of the general standard applies, except as follows:
533 201.7.2.2 Identification
534 Replacement of the first paragraph:
535 The MEDICAL BED shall be marked with the name or trademark and address of the
536 MANUFACTURER, MODEL OR TYPE REFERENCE and means to allow traceability.
537 The detachable components shall be marked with the name or trademark and address of the
538 MANUFACTURER, MODEL OR TYPE REFERENCE and means to allow traceability unless mis-
539 identification does not present an unacceptable RISK.
540 Additional subclauses:
541 201.7.2.2.101 * Marking of maximum PATIENT weight and SAFE WORKING LOAD
542 a) The MEDICAL BED shall be marked with the corresponding maximum PATIENT weight
543 (see 201.9.8.3.1) and SAFE WORKING LOAD (for symbol see Figure 201.106).

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545 Figure 201.106 – Graphic symbol for maximum PATIENT weight
546 and SAFE WORKING LOAD
547 b) Detachable parts of a MEDICAL BED of a mass of more than 20 kg shall be marked with
548 symbol ISO 7000-1321B:, including the actual mass, at least in kg, as in Figure
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