Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO/DIS 80601-2-13:2019)

CEN/BT C082/2011:  DOW = DAV + 36 months
2018-10-08 - ISO 80601-2-13 is linked to the MDR however, no mandate yet as no Sreq is available

Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen (ISO/DIS 80601-2-13:2019)

Dieses Dokument gilt für die Basissicherheit und wesentlichen Leistungsmerkmale eines Anästhesie-Arbeitsplatzes für die Applikation einer Inhalationsanästhesie unter ständiger Aufsicht eines fachlich ausgebildeten Bedieners.
Dieses Dokument legt die besonderen Anforderungen an einen vollständigen Anästhesie-Arbeitsplatz und an nachfolgend angeführte Bauteile von Anästhesie-Arbeitsplätzen fest, die, obwohl sie als einzelne „selbstständige“ Geräte zu betrachten sind, auch in Verbindung mit anderen relevanten Anästhesie-Arbeitsplatz-Bauteilen unter Bildung eines entsprechend festgelegten Anästhesie-Arbeitsplatzes eingesetzt werden können:
–   Anästhesiegas-Abgabesystem;
–   Anästhesie-Atemsystem;
–   Anästhesiegas-Fortleitungssystem;
–   Anästhesiemitteldampf-Abgabesystem;
–   Anästhesie-Beatmungsgerät;
–   Überwachungsgerät;
–   Alarmsystem;
–   Schutzvorrichtung.
ANMERKUNG 1   Die Überwachungsgeräte, Alarmsysteme und Schutzvorrichtungen sind in Tabelle AA.1 zusammengefasst.
Ein als Ganzes bereitgestellter Anästhesie-Arbeitsplatz und dessen einzelne Bauteile werden in Bezug auf die Allgemeinen Festlegungen als ME-Geräte oder ME-Systeme betrachtet.
ANMERKUNG 2   Die Gültigkeit dieses Dokuments ist in Tabelle AA.2 wiedergegeben.
Dieses Dokument gilt auch für das Zubehör, das vom Hersteller für den Anschluss an einen Anästhesie-Arbeitsplatz vorgesehen ist, wenn die Eigenschaften dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale eines Anästhesie-Arbeitsplatzes beeinträchtigen können.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf Anästhesie-Arbeitsplatz-Bauteile vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf den Anästhesie-Arbeitsplatz und auf dessen Bauteile, einschließlich Zubehör, zu.
Die mit der vorgesehenen physiologischen Funktion des Anästhesie-Arbeitsplatzes oder seiner Bauteile innerhalb des Anwendungsbereiches dieses Dokuments direkt verbundenen Gefährdungen bleiben von den spezifischen Anforderungen (Festlegungen) dieses Dokuments unberücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der Allgemeinen Festlegungen.

Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie (ISO/DIS 80601-2-13:2019)

Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo (ISO/DIS 80601-2-13:2019)

General Information

Status
Not Published
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Due Date
05-Jan-2021
Completion Date
05-Jan-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-13:2019
01-november-2019
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo (ISO/DIS 80601-2-13:2019)

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and

essential performance of an anaesthetic workstation (ISO/DIS 80601-2-13:2019)

Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen
(ISO/DIS 80601-2-13:2019)

Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et

de performances essentielles pour les postes de travail d'anesthésie (ISO/DIS 80601-2-

13:2019)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-13
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-13:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-13:2019
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oSIST prEN ISO 80601-2-13:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-13
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-09-03 2019-11-26
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
Appareils électromédicaux —

Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de

travail d'anesthésie
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-13:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
ISO/DIS 80601-2-13:2019(E)
14 Contents

15 Foreword .......................................................................................................................................................................... v

16 Introduction.................................................................................................................................................................. vii

17 201.1 Scope, object and related standards ......................................................................................................... 1

18 201.2 Normative references ...................................................................................................................................... 3

19 201.3 Terms and definitions...................................................................................................................................... 6

20 201.4 General requirements .................................................................................................................................. 11

21 201.5 General requirements for testing ME equipment .............................................................................. 13

22 201.6 Classification of ME equipment or ME systems ................................................................................... 14

23 201.7 ME equipment identification, marking and documents .................................................................. 14

24 201.8 Protection against electrical hazards from ME equipment ............................................................ 19

25 201.9 Protection against mechanical hazards of ME equipment and ME systems .............................. 20

26 201.10 Protection against unwanted and excessive radiation hazards .................................................. 21

27 201.11 Protection against excessive temperatures and other hazards .................................................. 22

28 201.12 Accuracy of controls and instruments and protection against hazardous outputs ............. 24

29 201.13 Hazardous situations and fault conditions .......................................................................................... 30

30 201.14 Programmable electrical medical systems (PEMS)............................................................................ 30

31 201.15 Construction of ME equipment ................................................................................................................. 31

32 201.16 ME systems ...................................................................................................................................................... 31

33 201.17 Electromagnetic compatibility of ME equipment and ME systems .............................................. 32

34 201.101 Additional requirements for anaesthetic gas delivery systems ........................................... 33

35 201.102 Additional requirements for an anaesthetic breathing system ........................................... 39

36 201.103 Additional requirements for an anaesthetic gas scavenging system ................................. 51

37 201.104 Additional requirements for an anaesthetic vapour delivery system ................................ 56

38 201.105 Additional requirements for an anaesthetic ventilator .......................................................... 61

39 201.106 Display of pressure-volume loops ................................................................................................. 68

40 201.107 Clinical evaluation ............................................................................................................................... 68

41 202 Electromagnetic disturbances — Requirements and tests ........................................................... 68

42 203 General requirements for radiation protection in diagnostic X-ray equipment .................. 69

43 206 Usability ........................................................................................................................................................... 69

44 208 General requirements, tests and guidance for alarm systems in medical electrical

45 equipment and medical electrical systems .......................................................................................... 70

COPYRIGHT PROTECTED DOCUMENT

46 209 Requirements for environmentally conscious design .................................................................... 71

© ISO 2019

47 211 Requirements for medical electrical equipment and medical electrical systems used

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

48 in the home healthcare environment ................................................................................................... 71

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

49 212 Requirements for medical electrical equipment and medical electrical systems

below or ISO’s member body in the country of the requester.

50 intended for use in the emergency medical services environment ........................................... 71

ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
© ISO 2018 – All rights reserved iii
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
14 Contents

15 Foreword .......................................................................................................................................................................... v

16 Introduction.................................................................................................................................................................. vii

17 201.1 Scope, object and related standards ......................................................................................................... 1

18 201.2 Normative references ...................................................................................................................................... 3

19 201.3 Terms and definitions...................................................................................................................................... 6

20 201.4 General requirements .................................................................................................................................. 11

21 201.5 General requirements for testing ME equipment .............................................................................. 13

22 201.6 Classification of ME equipment or ME systems ................................................................................... 14

23 201.7 ME equipment identification, marking and documents .................................................................. 14

24 201.8 Protection against electrical hazards from ME equipment ............................................................ 19

25 201.9 Protection against mechanical hazards of ME equipment and ME systems .............................. 20

26 201.10 Protection against unwanted and excessive radiation hazards .................................................. 21

27 201.11 Protection against excessive temperatures and other hazards .................................................. 22

28 201.12 Accuracy of controls and instruments and protection against hazardous outputs ............. 24

29 201.13 Hazardous situations and fault conditions .......................................................................................... 30

30 201.14 Programmable electrical medical systems (PEMS)............................................................................ 30

31 201.15 Construction of ME equipment ................................................................................................................. 31

32 201.16 ME systems ...................................................................................................................................................... 31

33 201.17 Electromagnetic compatibility of ME equipment and ME systems .............................................. 32

34 201.101 Additional requirements for anaesthetic gas delivery systems ........................................... 33

35 201.102 Additional requirements for an anaesthetic breathing system ........................................... 39

36 201.103 Additional requirements for an anaesthetic gas scavenging system ................................. 51

37 201.104 Additional requirements for an anaesthetic vapour delivery system ................................ 56

38 201.105 Additional requirements for an anaesthetic ventilator .......................................................... 61

39 201.106 Display of pressure-volume loops ................................................................................................. 68

40 201.107 Clinical evaluation ............................................................................................................................... 68

41 202 Electromagnetic disturbances — Requirements and tests ........................................................... 68

42 203 General requirements for radiation protection in diagnostic X-ray equipment .................. 69

43 206 Usability ........................................................................................................................................................... 69

44 208 General requirements, tests and guidance for alarm systems in medical electrical

45 equipment and medical electrical systems .......................................................................................... 70

46 209 Requirements for environmentally conscious design .................................................................... 71

47 211 Requirements for medical electrical equipment and medical electrical systems used

48 in the home healthcare environment ................................................................................................... 71

49 212 Requirements for medical electrical equipment and medical electrical systems

50 intended for use in the emergency medical services environment ........................................... 71

© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 80601-2-13:2019
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51 Annex C (informative) Guide to marking and labelling requirements for ME equipment and

52 ME systems or their parts........................................................................................................................... 72

53 Annex D (informative) Symbols on marking ................................................................................................... 82

54 Annex AA (informative) Particular guidance and rationale ...................................................................... 85

55 Annex BB (normative) Test for flammability of anaesthetic agent ....................................................... 102

56 Annex CC (informative) Terminology — alphabetized index of defined terms ................................. 103

57 Bibliography ............................................................................................................................................................... 107

58 Annex ZA (informative) .......................................................................................................................................... 108

iv © ISO 2019 – All rights reserved
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oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
60 Foreword

61 ISO (the International Organization for Standardization) is a worldwide federation of national

62 standards bodies (ISO member bodies). The work of preparing International Standards is normally

63 carried out through ISO technical committees. Each member body interested in a subject for which a

64 technical committee has been established has the right to be represented on that committee.

65 International organizations, governmental and non-governmental, in liaison with ISO, also take part in

66 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

67 matters of electrotechnical standardization.

68 The procedures used to develop this document and those intended for its further maintenance are

69 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

70 different types of ISO documents should be noted. This document was drafted in accordance with the

71 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

72 Attention is drawn to the possibility that some of the elements of this document may be the subject of

73 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

74 any patent rights identified during the development of the document will be in the Introduction and/or

75 on the ISO list of patent declarations received (see www.iso.org/patents).

76 Any trade name used in this document is information given for the convenience of users and does not

77 constitute an endorsement.

78 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

79 expressions related to conformity assessment, as well as information about ISO's adherence to the

80 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

81 www.iso.org/iso/foreword.html.

82 This document was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic

83 and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines and

84 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62 D,

85 Electromedical equipment.

86 This second edition cancels and replaces the first edition (ISO 80601-2-13:2011 including ISO 80601-2-

87 13:2011/AMD 1:2015 and ISO 80601-2-13:2011/AMD 2:2018), which has been technically revised

88 The main technical changes compared to the previous edition are as follows:
89 - incorporation of the texts of the amendments AMD 1:2015 and AMD 2:2018;
90 - consideration of anaesthetic workstations using Oxygen 93;
91 - updates of the normative references;

92 - inclusion of a normative reference to the series of standards ISO 18562 and to the standard

93 ISO 10993-1 on biocompatibility evaluation of breathing gas pathways and on biological evaluation

94 of medical devices respectively;
95 - amendments of the requirements on test equipment;
96 - amendments to the requirements on marking on the outside of the equipment;

97 - amendments to the requirements in the instructions for use, the technical description and design

98 documentation for anaesthetic equipment and its components;
© ISO 2018 – All rights reserved v
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oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
99 - amendments to the alarm condition for power supply;

100 - for the determination of the A-weighted sound pressure, replacement of the normative reference

101 ISO 3746 by ISO 3744:2010;
102 - amendments to the requirements on the internal electrical power source;
103 - amendments to the requirement on the connection for remote control;
104 - amendments to the requirements on the flow rate adjustment control;
105 - revision of the requirements on the reservoir bag connector;
106 - amendments of the requirements of the circle absorber assembly;

107 - amendments of the requirements of the accuracy on exhaled volume monitoring equipment;

108 - amendments to the requirements on timed ventilatory pause (expiratory pause);

109 - amendments of the pressure and flow-rate characteristics of the inspiratory and expiratory valves;

110 - addition of requirements on ventilation modes;

111 - amendments to the requirements on the adjustable pressure limitation protection device;

112 - addition of the normative reference to IEC 60601-1-12 for an anaesthetic workstation that is used

113 in an emergency medical services environment.
114 A list of all parts in the ISO 80601 series can be found on the ISO website.

115 Any feedback or questions on this document should be directed to the user’s national standards body. A

116 complete listing of these bodies can be found at www.iso.org/members.html.
vi © ISO 2019 – All rights reserved
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oSIST prEN ISO 80601-2-13:2019
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117 Introduction
118 In this document, the following print types are used:
119  Requirements and definitions: roman type.

120  Terms defined in Clause 3 of the general standard, in this particular standard and test

121 specifications: italic type.

122  Informative material appearing outside of tables, such as notes, examples and references: in smaller

123 type. Normative text of tables is also in a smaller type.
124 In referring to the structure of this document, the term

125  “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of

126 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

127  “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all

128 subclauses of Clause 201.7).

129 References to clauses within this document are preceded by the term “Clause” followed by the clause

130 number. References to subclauses within this document are by number only.

131 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

132 combination of the conditions is true.

133 The verbal forms used in this document conform to usage described in Clause 7 of the

134 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

135  “shall” means that conformance with a requirement or a test is mandatory for conformity with this

136 document;

137  “should” means that conformance with a requirement or a test is recommended but is not

138 mandatory for conformance with this document;

139  “may” is used to describe permission (e. g. a permissible way to achieve conformance with a

140 requirement or test);
141  "can" is used to describe a possibility or capability; and
142  "must" is used to express an external constraint.

143 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

144 that there is guidance or rationale related to that item in Annex AA.

145 This document considers both an anaesthetic workstation supplied complete and its individual

146 components in combination with its accessories. It has been structured to allow responsible

147 organizations to configure an anaesthetic workstation from individual components in conformance with

148 professional guidelines and to meet the needs of their clinical practice. In order to achieve this aim, this

149 document identifies particular requirements pertinent to specific anaesthetic workstation components,

150 including associated monitoring equipment, alarm system(s) and protection device(s), and defines the

151 interfaces.

152 Thus this document also defines requirements for individual components that can be used to form an

153 anaesthetic workstation.
© ISO 2018 – All rights reserved vii
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oSIST prEN ISO 80601-2-13:2019
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154 The following table identifies the individual components of an anaesthetic workstation and provides an

155 overview of the structure of this document.

156 Table 201.101 — Configuration of an anaesthetic workstation and corresponding organization of this

157 document
anaesthetic workstation
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-212
including associated monitoring
These are mandatory
equipment,
anaesthetic gas delivery system components;
alarm systems and
Clause 201.101 see also Table AA.1
protection devices
anaesthetic breathing system
Clause 201.102
anaesthetic gas scavenging system
Clause 201.103
including associated monitoring
These are optional
anaesthetic vapour delivery system equipment,
components;
Clause 201.104 alarm systems and
see also Table AA.1
protection devices
anaesthetic ventilator
Clause 201.105
158
159
160
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oSIST prEN ISO 80601-2-13:2019
ISO DIS 80601-2-13:2018
161 Medical electrical equipment — Part 2-13: Particular
162 requirements for basic safety and essential performance of an
163 anaesthetic workstation
164 201.1 Scope, object and related standards
165 IEC 60601-1:2005 + AMD 1:2012, Clause 1 applies, except as follows:
166 201.1.1 * Scope
167 Replacement:

168 This document is applicable to the basic safety and essential performance of an anaesthetic

169 workstation for administering inhalational anaesthesia whilst continuously attended by a

170 professional operator.

171 This document specifies particular requirements for a complete anaesthetic workstation and the

172 following anaesthetic workstation components which, although considered as individual devices

173 in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation

174 components, to form an anaesthetic workstation to a given specification:
175  anaesthetic gas delivery system;
176  anaesthetic breathing system;
177  anaesthetic gas scavenging system;
178  anaesthetic vapour delivery system;
179  anaesthetic ventilator;
180  monitoring equipment;
181  alarm system;
182  protection device.

183 NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.

184 An anaesthetic workstation supplied complete and its individual components are considered as

185 ME equipment or ME systems with regard to the general standard.
186 NOTE 2 The applicability of this document is indicated in Table AA.2.

187 This document is also applicable to those accessories intended by their manufacturer to be

188 connected to an anaesthetic workstation where the characteristics of those accessories can affect

189 the basic safety and essential performance of the anaesthetic workstation.
© ISO 2018 1
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190 If a clause or subclause is specifically intended to be applicable to anaesthetic workstation

191 components or its accessories only, the title and content of that clause or subclause will say so. If

192 that is not the case, the clause or subclause applies both to an anaesthetic workstation and its

193 individual components including accessories, as relevant.

194 Hazards inherent in the intended physiological function of an anaesthetic workstation and its

195 individual components including accessories within the scope of this document are not covered by

196 specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

197 NOTE 3 See also 4.2 of the general standard.

198 This document is not applicable to any anaesthetic workstation intended for use with flammable

199 anaesthetic agents, as determined by Annex BB.
200 201.1.2 Object
201 Replacement:

202 The object of this document is to establish particular basic safety and essential performance

203 requirements for an anaesthetic workstation and its individual components designed for use in

204 the anaesthetic workstation (as defined in 201.3.209) and its accessories.
205 201.1.3 Collateral standards
206 Addition:

207 This document refers to those applicable collateral standards that are listed in Clause 2 of the

208 general standard and Clause 201.2 of this document.

209 IEC 60601-1-3:2008, IEC 60601-1-9 + AMD 1:2013, IEC 60601-1-11:2010 + AMD 1: 2018 do not

210 apply.
211 201.1.4 *Particular standards
212 Addition:

213 The numbering of clauses and subclauses of this document corresponds to that of IEC 60601-1

214 (the general standard) with the prefix “201” (e.g. 201.1 in this document addresses the content of

215 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is

216 the final digit(s) of the collateral standard document number (e.g. 202.4 in this document

217 addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 206.4 in this

218 document addresses the content of Clause 4 of the IEC 60601-1-6 collateral standard, etc.). The

219 changes to the text of the general standard are specified by the use of the following words:

220 “Replacement” means that the clause or subclause of the general standard or applicable collateral

221 standard is replaced completely by the text of this document.

222 “Addition” means that the text of this document is additional to the requirements of the general

223 standard or applicable collateral standard.

224 “Amendment” means that the clause or subclause of the general standard or applicable collateral

225 standard is amended as indicated by the text of this document.
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226 Subclauses, figures or tables which are additional to those of the general standard are numbered

227 starting from 201.101. However, due to the fact that definitions in the general standard are

228 numbered 3.1 to 3.154, additional definitions in this document are numbered beginning from

229 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

230 Subclauses or figures which are additional to those of a collateral standard are numbered starting

231 from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for

232 IEC 60601-1-6, etc.

233 The term “this document” is used to make reference to the general standard, any applicable

234 collateral standards and this particular standard taken together.

235 Where there is no corresponding clause or subclause in this document, the clause or subclause of

236 the general standard or applicable collateral standard, although possibly not relevant, applies

237 without modification; where it is intended that any part of the general standard or applicable

238 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is

239
...

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