FprEN IEC 80601-2-89:2025
(Main)Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children
Medizinische elektrische Geräte - Teil 2-89: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von medizinischen Betten für Kinder
Appareils électromédicaux - Partie 2-89: Exigences particulières pour la sécurité de base et les performances essentielles des lits médicaux pour enfants
Medicinska električna oprema - 2-89. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinskih postelj za otroke
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-89:2024
01-maj-2024
Medicinska električna oprema - 2-89. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih postelj za otroke
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and
essential performance of medical beds for children
Ta slovenski standard je istoveten z: prEN IEC 80601-2-89:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 80601-2-89:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 80601-2-89:2024
oSIST prEN IEC 80601-2-89:2024
62D/2113/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-89 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-03-01 2024-05-24
SUPERSEDES DOCUMENTS:
62D/1758A/CD, 62D/1783A/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
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This document is still under study and subject to change. It should not be used for reference purposes.
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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” clau ses
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 2-89: Particular requirements for the basic safety and essential
performance of medical beds for children
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.
oSIST prEN IEC 80601-2-89:2024
62D/2113/CDV – 2 – IEC CDV 80601-2-89 ED1
1 CONTENTS
2 FOREWORD.5
3 INTRODUCTION .7
4 201.1 Scope, object and related standards .7
5 201.2 Normative references .9
6 201.3 Terms and definitions . 10
7 201.4 General requirements . 15
8 201.5 General requirements for testing of ME EQUIPMENT . 1616
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 2020
10 201.7 ME EQUIPMENT identification, marking and documents . 20
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 27
12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 28
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 5656
14 201.11 Protection against excessive temperatures and other HAZARDS . 5656
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 5959
16 201.13 HAZARDOUS SITUATIONS and fault conditions . 6060
17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 6060
18 201.15 Construction of ME EQUIPMENT . 6060
19 201.16 ME SYSTEMS . 6464
20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 6464
21 Annex AA (informative) Particular guidance and rationale . 6565
22 AA.1 General guidance . 6565
23 Annex BB (normative) Additional design requirements for Home Care and recommendations
24 for all MEDICAL BEDS . 7979
25 BB.1 General . 7979
26 BB.2 Human factors (ergonomic) . 7979
27 BB.3 Functionality . 8080
28 Annex CC (informative) Particular guidance for assessing risk of entrapment in V-shaped
29 openings . 8383
30 Annex DD (informative) Guidance and recommendations for periodic inspection . 8989
31 DD.1 Inspection Intervals . 8989
32 DD.2 Inspection scope . 8989
33 DD.3 Qualification of personnel . 8989
34 DD.4 Inspection results . 8989
35 DD.5 Inspection record . 9090
36 Bibliography . 9191
37 Index of defined terms used in this particular standard. 9292
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40 FIGURES
41 Figure 201.101 – MEDICAL BED, general arrangement (example, schematic presentation only)
42 . 14
43 Figure 201.102 – Small finger probe ∅ 5,6 . 1616
44 Figure 201.103 – Entrapment test TOOLS . 17
45 Figure 201.104 – Loading pad . 18
46 Figure 201.105 – Impactor . 19
47 Figure 201.106 – Side impactor TOOL . 19
48 Figure 201.107 – Graphical symbol for maximum PATIENT weight and SAFE WORKING LOAD . 20
49 Figure 201.108 – Graphic symbol for machine washable MEDICAL BED . 2020
50 Figure 201.109 – Graphic symbol for jet stream washble MEDICAL BED . 21
51 Figure 201.110 – Graphic symbol for manual cleaning only . 21
52 Figure 201.111 – Description of allowed length of PATIENT . 22
53 Figure 201.112 – Example of equivalent marking for positioning PATIENT in MEDICAL BED . 23
54 Figure 201.113 – MEDICAL BED function controls and/or actuators: guidelines for creating
55 graphical symbols… .
56 Figure 201.114 – Examples of marking on the MEDICAL BED of storage location for wired and
57 wireless PENDANT CONTROLS . 25
58 Figure 201.115 – Example of MEDICAL BED with segmented or split SIDE RAIL . 2929
59 Figure 201.116 – Example of MEDICAL BED with single piece SIDE RAIL and PROTECTION PANEL
60 . 3030
61 Figure 201.117 – Dimension of handle for LIFTING POLE . 3434
62 Figure 201.118 – Allowable spacing for fingers in areas of normal reach around the perimeter
63 of the MATTRESS SUPPORT PLATFORM . 3535
64 Figure 201.119 – Example using barriers for clearance measurement around the perimeter of
65 the MATTRESS SUPPORT PLATFORM to mitigate patient-finger entrapment . 3636
66 Figure 201.120 – Clearance areas . 3737
67 Figure 201.121 – Required minimum radii of edges and corners . 3838
68 Figure 201.122 – Retention of loop and mass . 3939
69 Figure 201.123 – Lateral stability test along the side of the MEDICAL BED . 4242
70 Figure 201.124 – Longitudinal stability test with removable FOOT BOARD . 4242
71 Figure 201.125 – Longitudinal stability test with fixed HEAD/FOOT BOARDS . 4343
72 Figure 201.126 – Distribution of SAFE WORKING LOAD for tests . 4646
73 Figure 201.127 – Position of loading pad and impactor . 4949
74 Figure 201.128 – Impact to slats and solid elements of MEDICAL BEDS . 5151
75 Figure 201.129 – Application of forces for test of SIDE RAIL. 5353
76 Figure 201.130 – Height of SIDE RAIL / PROTECTION PANELS . 5555
77 Figure 201.131 – Configurations of the MATTRESS SUPPORT PLATFORM . …63
78 Figure AA.1 – Example of marking for compatible mattresses specified by the MANUFACTURER
79 . 6767
80 Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the MANUFACTURER .
81 67
82 Figure AA.3 – Resultant forces without mattress . 7070
83 Figure AA.4 – Resultant forces with mattress . 7070
84 Figure AA.5 – Example of 40 mm gap measurement of B . 7070
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85 Figure AA.6 – Angle measurement example of B . 7070
86 Figure AA.7 – Placement of measurement TOOL for measurement of D . 7171
X
87 Figure AA.8 – Example of area DX measurement that passes . 7272
88 Figure AA.9 – Example of area D measurement that fails (on limit) . 7272
X
89 Figure AA.10 – Example of area DX measurement that fails . 7272
90 Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 7373
91 Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 7373
92 Figure AA.13 – Example of potential PATIENT entrapment in area B . 7373
93 Figure AA.14 – Example of potential PATIENT entrapment in area C between split SIDE RAIL
94 . 7373
95 Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL and
96 HEAD BOARD . 7373
97 Figure AA.16 – Example of potential PATIENT entrapment in area D . 7373
98 Figure AA.17 – Example of potential PATIENT entrapment in area A below a single piece SIDE
99 RAIL . 7474
100 Figure BB.1 – Schematic presentation of under MEDICAL BED clearance. 8181
101 Figure BB.2 – Recommendations and requirements regarding angles for different sections of
102 the MATTRESS SUPPORT PLATFORM . 8282
103 Figure CC.1 – Wedge TOOL . 8484
104 Figure CC.2 – V-shaped opening in relation to B. 8585
105 Figure CC.3 – Pass/fail in relation to area B . 8686
106 Figure CC.4 – Positioning of wedge TOOL. 8787
107 Figure CC.5 – Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD . 8787
108 Figure CC.6 – Pass/fail in relation to area C between split SIDE RAILS . 8888
109 TABLES
110 *Table 201.101 – Protection against PATIENT entrapment . 3031
111 Table 201.102 – Minimum SAFE WORKING LOADS . 4545
112 Table 201.103 – Protection against inadvertent PATIENT falls and climbing out of MEDICAL BED
113 . 5656
114 Table 201.104 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED
115 PARTS . 5757
116 Table AA.1 – Protection against PATIENT entrapment in non-moving parts . 6969
117 Table AA.2 – Height of protective barriers according to age . 7777
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119 INTERNATIONAL ELECTROTECHNICAL COMMISSION
120 ____________
122 MEDICAL ELECTRICAL EQUIPMENT –
124 Part 2-89: Particular requirements for the basic safety
125 and essential performance of medical beds for children
128 FOREWORD
129 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
130 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
131 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
132 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical
133 Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
134 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt
135 with may participate in this preparatory work. International, governmental and non -governmental organizations
136 liaising with the IEC also participate in this preparation. IEC collaborates closely with the International
137 Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two
138 organizations.
139 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
140 consensus of opinion on the relevant subjects since each technical committee has representation from all
141 interested IEC National Committees.
142 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
143 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
144 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
145 misinterpretation by any end user.
146 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
147 transparently to the maximum extent possible in their national and regional publications. Any divergence
148 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
149 the latter.
150 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
151 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
152 services carried out by independent certification bodies.
153 6) All users should ensure that they have the latest edition of this publication.
154 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
155 members of its technical committees and IEC National Committees for any personal injury, property damage or
156 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
157 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
158 Publications.
159 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
160 indispensable for the correct application of this publication.
161 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
162 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
163 International standard IEC 80601-2-89 has been prepared by IEC subcommittee 62D: Electrical
164 equipment in medical practice, and by ISO technical committee 173: Assistive products for
165 persons with disability. It is published as double logo standard.
166 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
167 In this standard, the following print types are used:
168 – Requirements and definitions: roman type.
169 – Test specifications: italic type.
170 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
171 Normative text of tables is also in a smaller type.
172 – Terms defined in clause 3 of the general standard, in this particular standard or as noted :
173 SMALL CAPITALS.
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174 In referring to the structure of this standard, the term
175 – “clause” means one of the seventeen numbered divisions within the table of contents,
176 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
177 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
178 subclauses of Clause 7).
179 References to clauses within this standard are preceded by the term “Clause” followed by the
180 clause number. References to subclauses within this collateral standard are by number only.
181 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
182 combination of the conditions is true.
183 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
184 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
185 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
186 this standard;
187 – “should” means that compliance with a requirement or a test is recommended but is not
188 mandatory for compliance with this standard;
189 – “may” is used to describe a permissible way to achieve compliance with a requirement or
190 test.
191 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
192 indicates that there is guidance or rationale related to that item in Annex AA.
193 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
194 equipment, can be found on the IEC website.
195 The committee has decided that the contents of the base publication and its amendment will
196 remain unchanged until the stability date indicated on the IEC web site under
197 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
198 publication will be
199 • reconfirmed,
200 • withdrawn,
201 • replaced by a revised edition, or
202 • amended.
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203 INTRODUCTION
204 IEC 80601-2-52 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS for
205 ADULTS, hence not covering requirement for beds for CHILDREN and ADULTS with atypical
206 anatomy. This particular standard is based on EN 50637, which was created pursuant to
207 Mandate M/467 Medical beds issued by the European Commission with the following
208 background information:
209 It appears, from a first analysis undertaken by EU Competent Authorities, that the current set
210 of standards is not adapted to the needs of CHILDREN or ADULTS with an atypical anatomy. IEC
211 80601-2-52 does not foresee a maximum distance for the bars that is small enough to prevent
212 accidents.
213 According to the EU Competent Authorities’ representatives, a part of the safety problem is due
214 to the fact that medical beds for ADULTS are not appropriately labelled as being designed only
215 for ADULTS with a normal anatomy. Users are therefore not always aware of the risk of medical
216 beds for young PATIENTS or for ADULTS with an atypical anatomy. Hospital administrations do
217 not always see a need to buy medical beds which are appropriate for CHILDREN or for ADULTS
218 with an atypical anatomy. Therefore, clear labelling of the targeted PATIENT groups for medical
219 beds complying with IEC 80601-2-52 could reduce the risk of inappropriate use of this kind of
220 medical beds for CHILDREN or for ADULTS with an atypical anatomy.
221 EU Competent Authorities’ representatives also stated that there is a need for the development
222 of requirements for MEDICAL BEDS and COTS for CHILDREN and ADULTS with an atypical anatomy.
223 In order to prevent IEC 80601-2-52 from being extraordinarily complex to use, CLC/TC 62
224 decided to develop this particular standard rather than further amending IEC 80601-2-52 in
225 relation to use for CHILDREN and ADULTS with an atypical anatomy.
226 This standard is based on EN50637 and IEC 80601-2-52 with input from the following standards
227 and reports:
228 • EN 716-1, Furniture — Children's cots and folding cots for domestic use — Part 1: Safety
229 requirements
230 • EN 716-2, Furniture — Children's cots and folding cots for domestic use — Part 2: Test
231 methods
232 • EN 1130-2, Furniture — Cribs and cradles for domestic use — Part 2: Test methods
233 • EN 747-1, Furniture — Bunk beds and high beds — Part 1: Safety, strength and durability
234 requirements
235 • EN 747-2, Furniture — Bunk beds and high beds — Part 2: Test methods
236 • CEN/TR 13387 (all parts), Child use and care articles — General safety guidelines
237 • DIN 32623, Hospital children's cots made from metal and plastic — Safety requirements and
238 testing
239 • Nordic Requirements specification for Adjustable beds for disabled children
240 201.1. Scope, object and related standards
241 Clause 1 of the general standard applies, except as follows:
—————————
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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242 201.1.1 * Scope
243 Replacement:
244 This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS,
245 hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined
246 in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for
247 ADULTS in 201.3.201).
248 This standard applies to electrical or non-electrical MEDICAL BEDS with nonadjustable and
249 electrical / mechanical adjustable functions.
250 This standard applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a
251 body length of 155 cm.
252 NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with
253 the child or that the bed will be used by an ADULT.
254 If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g.
255 INTERNAL LENGTH of 180 cm or more, then it shall fulfil both IEC 80601-2-52 and this particular
256 standard.
257 This Standard does not apply to:
258 • ADULT only beds covered by IEC 80601-2-52
259 • incubators covered by IEC 60601-2-19;
260 • devices for which the INTENDED USE is mainly for examination or transportation under
261 medical supervision (e.g. stretcher, examination table).
262 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME
263 SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
264 the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
265 HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within
266 the scope of this standard are not covered by specific requirements in this standard except in
267 7.2.13 and 8.4.1 of the general standard.
268 NOTE See also 4.2 of the general standard.
269 201.1.2 Object
270 Replacement:
271 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
272 PERFORMANCE requirements and test methods for MEDICAL BEDS as defined in 201.3.219
273 intended for CHILDREN as defined in 201.3.207 and ADULTS with atypical anatomy.
274 201.1.3 Collateral standards
275 Addition:
276 This particular standard refers to those applicable collateral standards that are listed in Clause
277 2 of the general standard and corrigenda and Clause 2 of this particular standard.
278 IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in the
279 IEC 60601-1 series apply as published.
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280 201.1.4 Particular standards
281 Replacement:
282 In the IEC 60601 series, particular standards may modify, replace or delete requirements
283 contained in the general standard and collateral standards as appropriate for the particular ME
284 EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCe
285 requirements.
286 A requirement of this particular standard takes priority over the general standard.
287 The numbering of clauses and subclauses of this particular standard corresponds to that of the
288 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of
289 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where
290 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
291 standard addresses the content of Clause 4 of the IEC 60601-1-2:2015 collateral standard,
292 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3:2008
293 collateral standard, etc.). The changes to the text of the general standard are specified by the
294 use of the following words:
295 "Replacement" means that the clause or subclause of the general standard or applicable
296 collateral standard is replaced completely by the text of this particular standard.
297 "Addition" means that the text of this particular standard is additional to the requirements of EN
298 60601-1:2006 or applicable collateral standard.
299 "Amendment" means that the clause or subclause of the general standard or applicable
300 collateral standard is amended as indicated by the text of this particular standard.
301 Subclauses, figures or tables which are additional to those of the general standard are
302 numbered starting from 201.101. However, due to the fact that definitions in the general
303 standard are numbered 3.1 through 3.147, additional definitions in this standard are numbered
304 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
305 aa), bb), etc.
306 Subclauses, figures or tables which are additional to those of a collateral standard are
307 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC
308 60601-1-2, 203 for IEC 60601-1-3, etc.
309 The term "this standard" is used to make reference to EN 60601-1:2006, any applicable
310 collateral standards and this particular standard taken together.
311 Where there is no corresponding clause or subclause in this particular standard, the clause or
312 subclause of the general standard or applicable collateral standard, although possibly not
313 relevant, applies without modification; where it is intended that any part of the general standard
314 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
315 to that effect is given in this particular standard.
316 201.2 Normative references
317 NOTE Informative references are listed in the Bibliography.
318 Clause 2 of the general standard applies except as follows:
319 Addition:
320 EN 71-3, Safety of toys — Part 3: Migration of certain elements
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321 EN 716-2, Furniture — Children's cots and folding cots for domestic use — Part 2: Test methods
322 EN 597-1 Furniture – Assessment of the ignitability of mattresses and upholstered bed bases
323 – Part 1: Ignition Source: Smouldering Cigarette
324 EN 597-2 Furniture — Assessment of ignitability of mattresses and upholstered bed bases —
325 Part 2: Ignition source: match-flame equivalent
326 ISO 7619-2, Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part
327 2: IRHD pocket meter method
328 IEC 50525-2-21, Electric cables — Low voltage energy cables of rated voltages up to and
329 including 450/750 V (Uo/U) — Part 2-21: Cables for general applications — Flexible cables with
330 crosslinked elastomeric insulation
331 IEC 60068-2-31, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
332 primarily for equipment-type specimens (IEC 60068-2-31)
333 Replacement of the references to IEC 60227-1:1993 and IEC 60245-1:2003 (not to be dated
334 anymore):
335 IEC 60227-1, Polyvinyl chloride insulated cables of rated voltages up to and including 450/750
336 V — Part 1: General requirements
337 IEC 60245-1, Rubber insulated cables — Rated voltages up to and including 450/750 V — Part
338 1: General requirements
339 Deletion:
340 ISO 9614-1, Acoustics — Determination of sound power levels of noise sources using sound
341 intensity — Part 1: Measurement at discrete points
342 201.3 Terms and definitions
343 For the purposes of this document, the terms and definitions given in Clause 3 of the general
344 standard apply, except as follows.
345 NOTE An index of defined terms is found at the end of this document.
346 201.3.67
347 MULTIPLE SOCKET-OUTLET
348 MSO
349 Replacement:
350 one or more socket-outlets intended to be connected to, or integral with, flexible cables or cords
351 or ME EQUIPMENT for SUPPLY MAINS or equivalent voltage
352 NOTE 1 to entry: A MULTIPLE SOCKET-OUTLET can be a separate item or an integral part of equipment.
353 201.3.76
354 PATIENT
355 Replacement:
356 person undergoing a medical procedure or PERSON WITH DISABILITY
357 NOTE 1 to entry: Whenever the term PATIENT is used, it comprises both ADULTS with an atypical anatomy and
358 CHILDREN.
359 201.3.109
360 SAFE WORKING LOAD
361 SWL
362 Replacement:
363 The SAFE WORKING LOAD is the sum of:
364 1) the PATIENT;
365 2) the mattress;
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366 3) the ACCESSORIES of the MEDICAL BED, only if they are supported by the support system
367 of the MEDICAL BED; and
368 4) the SAFE WORKING LOADS supported by those ACCESSORIES, excluding PATIENT weight.
369 201.3.131
370 * TRAPPING ZONE
371 Addition:
372 locations where the PATIENT or other persons can become entrapped, entangled, wedged, or
373 stuck in or between parts of the MEDICAL BED, such as the SIDE RAILS, HEAD/FOOT BOARD,
374 MATTRESS SUPPORT PLATFORM or mattress
375 Addition:
376 201.3.201
377 ADULT
378 PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than 40
379 kg and a body mass index (BMI) equal to or more than 17, or having a physical size, mass, and
380 body index as defined by the MANUFACTURER’S RISK MANAGEMENT FILE
381 [Source: IEC 80601-2-52, 201.3.222]
382 201.3.202
383 * APPLICATION ENVIRONMENT 1
384 intensive/critical care provided in a hospital where 24 h medical supervision and constant
385 monitoring is required and provision of life support system/equipment used in medical
386 procedures is essential to maintain or improve the vital functions of the PATIENT
387 201.3.203
388 * APPLICATION ENVIRONMENT 2
389 acute care provided in a hospital or other medical facility where medical supervision and
390 monitoring is required and ME EQUIPMENT used in medical procedures is often provided to help
391 maintain or improve the condition of the PATIENT
392 201.3.204
393 * APPLICATION ENVIRONMENT 3
394 long-term care in a medical area where medical supervision is required and monitoring is
395 provided if necessary and ME EQUIPMENT used in medical procedures may be provided to help
396 maintain or improve the condition of the PATIENT
397 NOTE 1 to entry: This includes use in CHILDREN’S nursing homes and in rehabilitation facilities.
398 201.3.205
399 * APPLICATION ENVIRONMENT 4
400 care provided in a domestic area where ME EQUIPMENT is used to alleviate or compensate for
401 an injury, disability or disease
402 NOTE 1 to entry: This excludes use in all other application environments (e.g. CHILDREN’S nursing homes and
403 rehabilitation facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.
404 201.3.206
405 * APPLICATION ENVIRONMENT 5
406 outpatient (ambulatory) care, which is provided in a hospital or other medical facility, under
407 medical supervision where ME EQUIPMENT, is provided for the need of persons with illness, injury
408 or disability for treatment, diagnosis or monitoring
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409 201.3.207
410 CHILD
411 PATIENT having a body length equal to or less than 155 cm and a mass equal to or less than 70
412 kg and may display cognitive immaturity, exploratory behaviours and/or risk taking tendencies
413 NOTE 1 to entry: Body length is measured from crown to sole.
414 201.3.208
415 COT
416 MEDICAL BED with an INTERNAL LENGTH ≥ 90 cm and < 140 cm provided with PROTECTION PANELS
417 also intended for CHILDREN able to stand up in bed
418 NOTE 1 to entry: In other countries this may be referred to as other terms (e.g. crib).
420 201.3.209
421 CRIB
422 MEDICAL BED with an INTERNAL LENGTH < 90 cm provided with PROTECTION PERIMETER, intended
423 for CHILDREN until they are able to sit, kneel or to pull themselves up
424 NOTE 1 to entry: Excluded are MEDICAL BEDS with a swinging or rocking function.
425 NOTE 2 to entry In other countries this may be referred to as other terms (e.g. bassinet).
427 201.3.210
428 PERSON WITH DISABILITY
oSIST prEN IEC 80601-2-89:2024
IEC CDV 80601-2-89 ED1 – 13 – 62D/2113/CDV
429 person with one or more impairments, one or more activity limitations, one or more participation
430 restrictions or a combination thereof
431 [Source: ISO 9999:2016]
432 201.3.211
433 HEAD/FOOT BOARD
434 assembly/assemblies mounted to MEDICAL BED, which identifies for the PATIENT the edge of the
435 head or foot end of the MEDICAL BED and/or MATTRESS SUPPORT PLATFORM
436 NOTE 1 to entry It may be used as handles to push a MEDICAL BED intended to transport PATIENTS.
437 201.3.212
438 INTERNAL LENGTH
439 length of mattress support platform.
440 201.3.213
441 JUNIOR BED
442 MEDICAL BED with an INTERNAL LENGTH ≥ 140 and < 180 cm
443 201.3.214
444 LIFTING POLE
445 ACCESSORY attached to a MEDICAL BED and intended to assist support of a PATIENT when
446 changing position by providing a gripping support above the PATIENT
447 201.3.215
448 LOCKING DEVICE
449 mechanism intended to maintain the MEDICAL BED or parts of it in its locked position
450 201.3.216
451 LOCKING SYSTEM
452 mechanism consisting of a LOCKING DEVICE and one or more operating devices, which can
453 deactivate the LOCKING DEVICE, e.g. by pushing a button, pressing a lever or turning a knob
454 201.3.217
455 MATTRESS OVERLAY
456 supplementary support surface, which is intended to be placed on an existing mattress, and
457 generally used for prophylactic or therapeutic effect
458 201.3.218
459 MATTRESS SUPPORT PLATFORM
460 structure which supports a PATIENT surface (for example mattress). .
461 NOTE 1 to entry: The MATTRESS SUPPORT PLATFORM may articulate or change positions to facilitate various
462 therapeutic, diagnostic and convenience positions. See Figure 201.101 and 201.129 a) to 201.129 d).
oSIST prEN IEC 80601-2-89:2024
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464 Key
465 1 HEAD BOARD
466 2 Back section
467 3 Seat section
468 4 Upper leg section
469 5 Lower leg section
470 6 FOOT BOARD
471 Figure 201.101 – MEDICAL BED, general arrangement
472 (example, schematic presentation only)
473 201.3.219
474 * MEDICAL BED
475 device for which the INTENDED USE is sleeping/resting that contains a MATTRESS SUPPORT
476 PLATFORM and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of
477 disease or compensation for an injury or handicap
478 NOTE 1 to entry: Whenever the term MEDICAL BED is used it comprises CRIBS, COTS AND JUNIOR BEDS.
479 201.3.220
480 MOTION LOCKOUT CONTROL
481 auxiliary subsystem that deactivates motion controls
482 201.3.221
483 OVERSIZE COT
484 COT with an INTERNAL LENGTH ≥ 140 cm and < 180 cm provided with PROTECTION PANELS also
485 intended for CHILDREN able to stand up in bed
486 201.3.222
487 PENDANT CONTROL
488 handheld device, which has a FUNCTIONAL CONNECTION to the MEDICAL BED, controlling at least
489 MEDICAL BED articulations and/or movements
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IEC CDV 80601-2-89 ED1 – 15 – 62D/2113/CDV
490 NOTE 1 top entry: PENDANT CONTROLS may be wired or wireless, and may integrate other functions such as
491 communications, radio/TV, etc.
492 201.3.223
493 PROTECTION PERIMETER
494 fully enclosed solid physical barrier e.g. bowl or basin, which is integral to the overall
495 construction of a MEDICAL BED, which will prevent the PATIENT from falling out of bed and which
496 can be movable, e.g. sliding sides, drop sides, folding sides
497 NOTE 1 to entry: Wherever a solid physical barrier is used there might be a risk of suffocation caused by lack of
498 oxygen.
499 201.3.224
500 PROTECTION PANEL
501 physical barrier, which shall be integral to the overall construction of a MEDICAL BED and is
502 positioned to the side(s) and ends of the MEDICAL BED to prevent the PATIENT from getting out of
503 bed unaided, and which can be movable, e.g. sliding sides, drop sides, folding sides
504 NOTE 1 to entry: Whenever the term SIDE RAIL is used it comprises a PROTECTION PANEL. See COT and CRIB.
505 201.3.225
506 SIDE RAIL
507 physical barrier, which may be a detachable ACCESSORY or integral to the overall construction
508 of a MEDICAL BED and is mounted to the side(s) of the MEDICAL BED
509 NOTE 1 to entry: When a SIDE RAIL is closed/fully raised, it provides a physical barrier, which is intended to reduce
510 the RISK of the PATIENT accidentally slipping or rolling off the mattress.
511 201.3.226
512 SPECIALITY MATTRESS
513 mattress intended for prophylactic or therapeutic effect
514 201.3.227
515 UNDERCARRIAGE
516 all components of the MEDICAL BED below the MATTRESS SUPPORT PLATFORM
517 201.4 General requirements
518 Clause 4 of the general standard applies, except as follows:
519 201.4.1 Source of power for ME EQUIPMENT
520 Delete this subclause.
521 201.4.2 *Risk management process for ME EQUIPMENT and ME SYSTEM
522 Addition:
523 The MANUFACTURER shall include, in the RISK MANAGEMENT process, HAZARDS related to PATIENTS
524 taller than 155 cm and with a mass greater than 70 kg.
525 Compliance is checked by inspection of the RISK MANAGEMENT FILE.
oSIST prEN IEC 80601-2-89:2024
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526 201.5 General requirements for testing of ME EQUIPMENT
527 Clause 5 of the general standard applies, except as follows:
528 Additional subclauses:
529 201.5.9.2.1 * Test finger
530 Replacement:
531 Parts of MEDICAL BEDS that are to be regarded as ACCESSIBLE PARTS are identified by inspection
532 and, where necessary, by testing. In case of doubt, accessibility is determined by a test with
533 the small finger probe shown in Figure 201.xxx, applied in a bent or straight position:
534 – for all positions of the MEDICAL BED when operated as in NORMAL USE,
535 – after opening of ACCESS COVERS and removal of parts, including lamps, fuses and fuse
536 holders, when:
537 1. the ACCESS COVERS can be opened without the use of a TOOL, or
538 2. the instructions for use instruct a LAY OPERATOR to open the relevant ACCESS COVER.
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