prEN IEC 60601-2-46:2022
(Main)Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationstischen
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base et les performances essentielles des tables d'opération
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-46:2022
01-maj-2022
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tablesMedizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von OperationstischenAppareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opérationTa slovenski standard je istoveten z: prEN IEC 60601-2-46:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 60601-2-46:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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62D/1939/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-46 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-03-25 2022-06-17
SUPERSEDES DOCUMENTS:
62D/1866/CD, 62D/1935/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
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 votingThe 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.TITLE:
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential
performance of operating tablesPROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
This revision project is to align with the Amendment projects of the IEC 60601 -1 series and to address some
technical updates to ED3. NCs are invited to submit their votes and comments at the CDV stage.
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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 permis sion
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1 CONTENTS
2 CONTENTS ............................................................................................................................ 2
3 FOREWORD ........................................................................................................................... 3
4 INTRODUCTION ..................................................................................................................... 5
5 201.1 Scope, object and related standards ....................................................................... 6
6 201.2 Normative references .............................................................................................. 8
7 201.3 Terms and definitions .............................................................................................. 8
8 201.4 General requirements ............................................................................................. 9
9 201.5 General requirements for testing ME EQUIPMENT ...................................................... 9
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 9
11 201.7 ME EQUIPMENT identification, marking and documents .............................................. 9
12 201.8 Protection against electrical HAZARDS from OPERATING TABLES ............................... 10
13 201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and14 ME SYSTEMS ................................................................................................................... 10
15 201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 13
16 NOTE : The collateral standard IEC 60601-1-3 is referenced in the general standard
17 and is covered under clause 203 of this document ......................................................... 13
18 201.11 Protection against excessive temperatures and other HAZARDS ............................. 13
19 201.12 Accuracy of controls and instruments and protection against hazardous20 outputs .......................................................................................................................... 13
21 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 14
22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................. 14
23 201.15 Construction of ME EQUIPMENT ............................................................................... 14
24 201.15.4 ME EQUIPMENT components and general assembly .................................................. 14
25 201.16 ME SYSTEMS .......................................................................................................... 14
26 201.17 Electromagnetic compatibility of OPERATING TABLES and ME SYSTEMS ..................... 14
27 202 Electromagnetic disturbances – Requirements and tests ............................................... 14
28 203 *Radiation protection in diagnostic X-ray equipment ...................................................... 18
29 Annexes ............................................................................................................................... 19
30 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
31 mixtures ........................................................................................................................ 20
32 Annex AA (informative) Particular guidance and rationale .................................................... 21
33 Bibliography .......................................................................................................................... 25
34 Index of defined terms used in this particular standard .......................................................... 26
36 Figure 202.101 – ENCLOSURE ad hoc test .............................................................................. 16
37 Figure 202.102 – POWER SUPPLY CORD ad hoc test ................................................................ 17
38 Figure 202.103 – ACCESSORy cable ad hoc test..................................................................... 17
39 Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
40 application ............................................................................................................................ 21
42 Table 201.101 – Determination of TENSILE SAFETY FACTOR ..................................................... 12
43 Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
44 application ............................................................................................................................ 22
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46 INTERNATIONAL ELECTROTECHNICAL COMMISSION
47 ____________
49 MEDICAL ELECTRICAL EQUIPMENT –
51 Part 2-46: Particular requirements for the basic safety
52 and essential performance of operating tables
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization compris ing
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
57 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
58 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
59 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
60 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
61 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
62 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
63 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
64 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
65 consensus of opinion on the relevant subjects since each technical committee has representation from all
66 interested IEC National Committees.67 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
68 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
69 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
70 misinterpretation by any end user.71 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
72 transparently to the maximum extent possible in their national and regional publications. Any divergence between
73 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
74 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
75 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
76 services carried out by independent certification bodies.77 6) All users should ensure that they have the latest edition of this publication.
78 7) No liability shall attach to IEC or its directors, employees, servants or agents incl uding individual experts and
79 members of its technical committees and IEC National Committees for any personal injury, property damage or
80 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
81 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
82 Publications.83 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
84 indispensable for the correct application of this publication.85 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
86 rights. IEC shall not be held responsible for identifying any or all such patent rights.
87 International standard IEC 60601-2-46 has been prepared by IEC subcommittee 62D
88 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
89 practice.90 This third edition cancels and replaces the second edition published in 2010 and constitutes a
91 technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005
92 edition of IEC 60601-1, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
93 The text of this standard is based on the following documents:FDIS Report on voting
62D/XXXX/FDIS 62D/XXXX/RVD
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95 Full information on the voting for the approval of this standard can be found in the report on
96 voting indicated in the above table.97 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
98 In this standard, the following print types are used:99 – Requirements and definitions: roman type.
100 – Test specifications: italic type.
101 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
102 Normative text of tables is also in a smaller type.103 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
104 NOTED: SMALL CAPITALS.105 In referring to the structure of this standard, the term
106 – “clause” means one of the numbered divisions within the table of contents, inclusive of all
107 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);108 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
109 subclauses of Clause 7).110 References to clauses within this standard are preceded by the term “Clause” followed by the
111 clause number. References to subclauses within this particular standard are by number only.
112 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
113 combination of the conditions is true.114 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
115 Directives, Part 2. For the purposes of this standard, the auxiliary verb:116 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
117 this standard;118 – “should” means that compliance with a requirement or a test is recommended but is not
119 mandatory for compliance with this standard;120 – “may” is used to describe a permissible way to achieve compliance with a requirement or
121 test.122 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
123 indicates that there is guidance or rationale related to that item in Annex AA.
124 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
125 equipment, can be found on the IEC website.126 The committee has decided that the contents of this publication will remain unchanged until the
127 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
128 the specific publication. At this date, the publication will be129 • reconfirmed,
130 • withdrawn,
131 • replaced by a revised edition, or
132 • amended.
133
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134 INTRODUCTION
135 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of OPERATING
136 TABLES. It amends and supplements IEC 60601-1:2005, IEC 60601-2:2005/AMD1:2012 and IEC
137 60601-1:2005/AMD2:2020, hereinafter referred to as the general standard.138 The aim of this third edition is to bring this particular standard up to date with reference to the
139 third edition of the general standard through reformatting and technical changes .
140 The requirements of this particular standard take priority over those of the general standard.
141 A “General guidance and rationale” for the more important requirements of this particular
142 standard is included in Annex AA. It is considered that knowledge of the reasons for these
143 requirements will not only facilitate the proper application of the standard but will, in due course,
144 expedite any revision necessitated by changes in clinical practice or as a result of developments
145 in technology. However, Annex AA does not form part of the requirements of this Standard.
146147
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148 MEDICAL ELECTRICAL EQUIPMENT –
149
150 Part 2-46: Particular requirements for the basic safety
151 and essential performance of operating tables
152
153
154
155 201.1 Scope, object and related standards
156 Clause 1 of the general standard applies, except as follows:
157 201.1.1 Scope
158 Replacement:
159 This particular standard specifies safety requirements for OPERATING TABLES, whether or not
160 having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING
161 TABLE top to or from the base or pedestal of an OPERATING TABLE with detachable OPERATING
162 TABLE top.163 NOTE See also 4.2 of the General Standard.
164 This particular standard does not apply to
165 – dental PATIENT chairs;: Dentistry-Stationary dental units and dental patient chair – Part 1
166 general requirements (see ISO 7494-1)167 – examination chairs and couches;
168 – PATIENT-supporting systems of diagnostic, interventional and therapeutic equipment; (see
169 IEC 60601-2-54 or IEC 60601-2-43)170 – OPERATING TABLE heating blankets; (see IEC 60601-2-35)
171 – PATIENT transfer equipment;
172 – delivery tables and delivery beds;
173 – medical beds; (see IEC 60601-2-52 and EN 50637)
174 – field tables.
175 201.1.2 Object
176 Replacement:
177 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
178 PERFORMANCE requirements for OPERATING TABLES as defined in 201.3.201.179 201.1.3 Collateral standards
180 Addition:
181 This particular standard refers to those applicable collateral standards that are listed in Clause
182 2 of the general standard and Clause 201.2 of this particular standard.______________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
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183 IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.
184 IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not
185 apply. All other published collateral standards in the IEC 60601-1 series apply as published.
186 201.1.4 Particular standards187 Replacement:
188 In the IEC 60601 series, particular standards may modify, replace or delete requirements
189 contained in the general standard and collateral standards as appropriate for the particular ME
190 EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
191 requirements.192 A requirement of a particular standard takes priority over the general standard.
193 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
194 Collateral standards are referred to by their document number.195 The numbering of clauses and subclauses of this particular standard corresponds to that of the
196 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of
197 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
198 where is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
199 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard,
200 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3
201 collateral standard, etc.). The changes to the text of the general standard are specified by the
202 use of the following words:203 "Replacement" means that the clause or subclause of the general standard or applicable
204 collateral standard is replaced completely by the text of this particular standard.
205 "Addition" means that the text of this particular standard is additional to the requirements of the
206 general standard or applicable collateral standard.207 "Amendment" means that the clause or subclause of the general standard or applicable
208 collateral standard is amended as indicated by the text of this particular standard.
209 Subclauses, figures or tables which are additional to those of the general standard are
210 numbered starting from 201.101. However, due to the fact that definitions in the general
211 standard are numbered 3.1 through 3.154, additional definitions in this standard are numbered
212 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
213 aa), bb), etc.214 Subclauses, figures or tables which are additional to those of a collateral standard are
215 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
216 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.217 The term "this standard" is used to make reference to the general standard, any applicable
218 collateral standards and this particular standard taken together.219 Where there is no corresponding clause or subclause in this particular standard, the clause or
220 subclause of the general standard or applicable collateral standard, although possibly not
221 relevant, applies without modification; where it is intended that any part of the general standard
222 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
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224 201.2 Normative references
225 Clause 2 of the general standard applies, except as follows:
226 Replacement:
227 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
228 safety and essential performance – Collateral standard: Electromagnetic disturbances –
229 Requirements and tests230 Amendment 1:2020
231
232 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
233 safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
234 ray equipment235 Amendment 1:2013
236 Amendment 2:2021
237
238 Addition:
239 IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
240 basic safety and essential performance of high frequency surgical equipment and high
241 frequency surgical accessories242 IEC 60601-2-43:2010, Medical electrical equipment – Part 2-43: Particular requirements for the
243 basic safety and essential performance of X-ray equipment for interventional procedures
244 Amendment 1:2017245 Amendment 2:2019
246
247 IEC 60601-2-54:2009, Medical electrical equipment – Part 2-54: Particular requirements for the
248 basic safety and essential performance of X-ray equipment for radiography and radioscopy
249 Amendment 1:2015250 Amendment 2:2018
251
252 ISO 20342-1:2019 Assistive products for tissue integrity when lying down — Part 1: General
253 requirements does not apply254 201.3 Terms and definitions
255 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC
256 60601-1:2005/AMD1:2012 and IEC 60601-2:2005/AMD2:2020 apply, except as follows:
257 NOTE An index of defined terms is found on page 26.258 Addition:
259 201.3.201
260 MOBILE OPERATING TABLE
261 OPERATING TABLE intended to be relocated from one location to another while supported by its
262 own wheels or equivalent means263 201.3.202
264 NORMAL POSITION
265 position of the OPERATING TABLE top with all sections set in the horizontal position
266 201.3.203267 OPERATING TABLE
268 device with the INTENDED USE of supporting and positioning a PATIENT during surgical procedures
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270 Note 1 to entry: This includes pre- and post-operative phases in general, surgical/medical procedures under
271 medical supervision.272 Note 2 to entry: The device may serve as a PATIENT-supporting systems during diagnostic, interventional and
273 therapeutic procedures but still considered to be a separate ME EQUIPMENT.274 201.3.204
275 TRANSPORTER
276 device intended for the transportation of an OPERATING TABLE top to or from the base or pedestal
277 of an OPERATING TABLE, or the transportation of the OPERATING TABLE top complete with the base
278 Note 1 to entry: This definition does not include devices intended to simplify the transport of the PATIENT from one
279 location to another without the transfer of parts associated with an OPERATING TABLE.
280 Note 2 to entry: The transportation can be done with or without a PATIENT in place.
281 201.3.205282 TRENDELENBURG POSITION
283 a supine PATIENT position where the body is in a single plane, with that plane inclined so that
284 the head is lower than the pelvis285 201.4 General requirements
286 Clause 4 of the general standard applies, except as follows.
287 201.4.3 Essential performance
288 Addition:
289 Besides the definition of the MANUFACTURER, the following shall be considered ESSENTIAL
290 PERFORMANCE for OPERATING TABLES:291 – Supporting a PATIENT without unintended movement (motorized or not) leading to an
292 unacceptable risk in a SINGLE FAULT CONDITION.293
294 201.4.7 SINGLE FAULT CONDITION for OPERATING TABLES
295 Addition:
296 The MANUFACTURER should provide means, where practical, to ensure that in a SINGLE FAULT
297 CONDITION the PATIENT support platform of the OPERATING TABLE can return to a position for
298 emergency treatment.299 NOTE 101 Examples of positions for emergency treatment are TRENDELENBURG or positions for cardiopulmonary
300 resuscitation (CPR), emergency back flattening.301 201.5 General requirements for testing ME EQUIPMENT
302 Clause 5 of the general standard applies.
303 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
304 Clause 6 of the general standard applies.
305 201.7 ME EQUIPMENT identification, marking and documents
306 Clause 7 of the general standard applies, except as follows:
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307 201.7.2 Marking on the outside of OPERATING TABLES or OPERATING TABLES parts
308 201.7.2.21 Mass of MOBILE OPERATING TABLES
309 This subclause of the general standard does not apply.
310 201.7.9.2 Instructions for use
311 201.7.9.2.1 General
312 Addition:
313 Instructions for use shall include information, regarding potential HAZARDS related to HIGH
314 FREQUENCY SURGICAL EQUIPMENT, cardiac defibrillators and cardiac defibrillator-monitors.
315 NOTE 101 Potential HAZARDS which have to be considered include but are not limited to: PATIENT burns, explosion
316 HAZARDS or electrical shock of the PATIENT or OPERATOR.317 201.8 Protection against electrical HAZARDS from OPERATING TABLES
318 Clause 8 of the general standard applies, except as follows:
319 201.8.6.7 POTENTIAL EQUALIZATION CONDUCTOR
320 Addition:
321 Where potential equalization is required, the APPLIED PARTS of OPERATING TABLES with
322 ACCESSIBLE PARTS which are not PROTECTIVELY EARTHED shall be provided with a potential
323 equalization terminal or a potential equalization connector .324 For OPERATING TABLES with a POTENTIAL EQUALIZATION terminal the impedance between the
325 potential equalization terminal or connector and any ACCESSIBLE PART shall not exceed 200 m.
326 Compliance is checked by using the test method of 8.6.4 of the general standard.
327 201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and328 ME SYSTEMS
329 Clause 9 of the general standard applies, except as follows:
330 201.9.2.3 Other MECHANICAL HAZARDS associated with moving parts
331 201.9.2.3.1 *Unintended movement
332 Addition:
333 Wireless remote control devices of OPERATING TABLES shall be clearly assigned by internal
334 means to the individual OPERATING TABLES.335 Compliance is checked by inspection.
336 201.9.4 Instability HAZARDS
337 201.9.4.2.2 *Instability excluding transport position
338 Item a)
339 Addition:
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340 OPERATING TABLES shall be subjected to SAFE WORKING LOAD.
341 NOTE See Figure AA.1 and Table AA.1 for guidance regarding mass distribution.
342 Additional requirement:343 OPERATING TABLES with transferable OPERATING TABLE tops shall be designed and manufactured
344 so as to minimize the RISK of physical injuries and of accidental separation of the OPERATING
345 TABLE tops when being transferred.346 Specifications concerning OPERATING TABLE top transfer operations shall indicate in the
347 instructions for use the safety elements inherent in the transfer operation.348 Compliance is checked by inspection and the following tests:
349 Having transferred the OPERATING TABLE top to the TRANSPORTER, the stability in NORMAL USE
350 test of 9.4.2.2 of the general standard shall be carried out. The OPERATING TABLE top shall not
351 disengage from the TRANSPORTER.352 The test is then repeated with the OPERATING TABLE top being placed on the base and the
353 stability test is carried out on the base immediately after transfer.354 201.9.4.2.4.3
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