SIST EN ISO 80601-2-13:2013

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2011)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 8835-2:2009
SIST EN ISO 8835-3:2009
SIST EN ISO 8835-3:2009/A1:2011
SIST EN ISO 8835-4:2009
SIST EN ISO 8835-5:2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHORYQHJDPHVWD]DDQHVWH]LMR,62
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO
80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performance essentielle pour les systèmes d'anesthésie (ISO 80601-2-13:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-13:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10



EUROPEAN STANDARD
EN ISO 80601-2-13

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2012
ICS 11.040.10 Supersedes EN ISO 8835-2:2009, EN ISO 8835-3:2009,
EN ISO 8835-4:2009, EN ISO 8835-5:2009,
EN 60601-2-13:2006
English Version
Medical electrical equipment - Part 2-13: Particular requirements
for basic safety and essential performance of an anaesthetic
workstation (ISO 80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performance Festlegungen für die Sicherheit einschließlich der
essentielle pour les systèmes d'anesthésie (ISO 80601-2- wesentlichen Leistungsmerkmale von Anästhesie-
13:2011) Arbeitsplätzen (ISO 80601-2-13:2011)
This European Standard was approved by CEN on 18 November 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under
the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved worldwide Ref. No. EN ISO 80601-2-13:2012: E
for CEN national Members.

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 80601-2-13:2012 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

2

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 80601-2-13:2012 (E)
Foreword
The text of ISO 80601-2-13:2011 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 80601-2-13:2012 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at
the latest by December 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8835-2:2009, EN ISO 8835-3:2009, EN ISO 8835-4:2009,
EN ISO 8835-5:2009, EN 60601-2-13:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2011 has been approved by CEN as a EN ISO 80601-2-13:2012 without any
modification.
3

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 80601-2-13:2012 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the Member
States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this standard
given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the
corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Corresponding essential
Clause(s)/subclause(s) of this EN Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.11.6.8; 201.102.3; 201.104.7 7.2 only the risks to patients during
NORMAL USE are addressed
201.11.6.3; 201.11.6.8 7.3
nd rd
201.7.2.105, 201.7.9.2.14 7.5, 2 and 3 paragraph
201.101.4.1.2; 201.11.6.3 7.6 IP classification according
IEC 60529 is governed by
EN 60601-1:2006
201.11.101; 201.104.7 8.1 Easy handling and contamination
by the patients are not addressed.
201.11.101 8.6
201.16.9.2.1; 201.16.101; 9.1
201.101.3; 201.101.4.1
201.101.4.2; 201.101.9;
201.102.5; 201.102.9;
201.103.4 to 201.103.7;
201.104.4; 201.104.5, 201.104.6;
201.105.4; 201.105.6
201.9.4; 201.9.4.2.4.3; 201.105.7, Clause 202 refers to EN 60601-1-
9.2 (First and second indents)
202; 209 2:2007,

Clause 209 refers to EN 60601-1-
9:2008
201.11; 201.102.4 9.3
201.12.4.104.1; 10.1
201.101.6.1; 201.104.2.2
4

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.7.4.2; 10.2
201.7.4.3 10.3
201.14 12.1 EN 62304:2006, 1.4
201.14, 201.14.101 12.1 a) EN 62304:2006, 1.4
201.11.8.102; 201.11.8.103 12.2
201.11.8.102 12.3
201.12.4.104.2; 201.12.4.105; 12.4 Clause 208 refers to
201.12.4.106; 208
EN 60601-1-8:2006
202 12.5 Clause 202 refers to EN 60601-1-
2:2007
201.9 12.7.1
201.9, 201.9.2.103 12.7.2
201.9, 201.11.8.102 12.7.3
201.15, 201.16, 201.101.4.2.1 12.7.4 Covered by compliance with
EN 60601-1:2006, 15.4.1 and 16.9

201.11 12.7.5 EN 60601-1:2006, Clause 11
201.101.4.1.3; 201.101.6.2; 12.8.1
201.101.6.3; 201.102.2.1;
201.102.2.2; 201.102.10.4;
201.104.2.1; 201.104.5;
201.105.2.1; 201.105.2.2;
201.12.4.104.2; 201.12.4.106; 12.8.2
201.12.4.107.1; 201.12.4.107.2;
201.12.4.107.3; 201.12.4.109;
201.101.2; 201.101.4.3;
201.102.10: 201.102.10.4;
201.104.5; 201.105.5; 201.105.8;
208
201.101.6.1; 201.104.2.1; 12.9
201.7, 201.7.2.104; 201.7.9.1; 13.1
201.102.1.1.1
201.7, 201.7.2.3; 201.7.2.101; 13.2
201.7.2.103; 201.7.2.107;
201.7.4.2
201.7.9.1 13.3 a)
201.7.2.101 13.3 e)
5

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.7, 201.7.2.101 13.3 f) The indication that the device is for
single use must be consistent

across the Community is not
addressed in a requirement.
201.7, 201.7.9.3.102 13.3 i)
201.7,
13.3 j)
201.7.2
201.7.2.102, 201.7.2.103,
201.7.2.104
201.7.2.107
201.7.4.2
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.1.1.4
201.102.5.2
201.102.5.3
201.102.5.4
201.102.5.7
201.103.1.1
201.104.1.1
201.104.2.1
201.104.6
201.105.6
201.7, 13.3 k)
201.7.2.3
201.104.1.1
201.7.2.101 13.3.l)
201.7.2.102; 201.102.5.2; 13.5
201.102.5.4; 201.102.5.5;
201.102.5.6; 201.103.5;
201.103.6; 201.104.4
201.7 13.6 a) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7 13.6 b) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.1 13.6 c)
201.7.9.2.14
201.11.8
201.11.8.101
201.11.8.103
201.12.4.102
201.12.4.103.3
201.12.4.106
201.12.4.107.2
201.12.4.108
201.101.1.1
201.101.1.2
201.102.1.2
6

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.102.7
201.102.8.2
201.102.9.2
201.102.9.3
201.102.10.3
201.103.1.2
201.104.1.2
201.104.2.1
201.104.6
201.105.1
201.105.2.2
201.105.5
201.7, 201.102.10.1 13.6 d) maintenance and frequency
covered by compliance with
201.103.3.1.5
EN 60601-1:2006, 7.9.2.13
208.5.2.2

201.7.9.2.14 13.6 f)
201.7 13.6 h), first paragraph only Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.14
201.7 13.6 i) Covered by compliance with
EN 60601-1:2006, 7.9
201.7.9.2.1
201.7.9.2.8
201.7.9.2.2 13.6 k)
201.7.9.2.14
201.12.4.103 ; 13.6 p)
201.12.4.104.1,
201.12.4.109; 201.101.6.1;
201.104.2.2;
201.7.9.2.1 13.6 q)

7

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 80601-2-13:2012 (E)
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.102 details the relevant
essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than essential requirements of Directive 93/42/EEC along with the corresponding clauses of this
European Standard. Table ZA.102, however, does not imply any citation in the OJEU under the machinery
directive and thus does not provide presumption of conformity for the machinery directive.
Table ZA.102 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that
are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/subclause(s) of this EHSR of Directive 2006/42/EC Qualifying remarks/notes
EN
201.9.2.102 1.1.4
201.9.2.103
1.1.8
201.7.4.2
1.2.2
201.9.2
201.9.2.104
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.9.2

201.104.1.1
201.104.2.1
206
208

1.5.4
201.101.3
201.101.4.1.1
201.101.4.1.2
201.101.9
201.102.5
201.102.8.1
201.102.9.1
201.103.4,
201.103.5;
201.103.6
201.103.7
201.104.4
201.105.4
201.105.6
201.9.2.101
1.6.2
201.8 1.6.3

Covered by compliance with
201.7 3.6.2
EN 60601-1:2006, 7.2
201.7.2.106

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European Standard.
8

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01

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
performance essentielle pour les systèmes d'anesthésie




Reference number
ISO 80601-2-13:2011(E)
©
ISO 2011

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-13:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO/IEC 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-13:2011(E)
Contents Page
Foreword .v
Introduction.vi
201.1 Scope, object and related standards.1
201.2 Normative references.3
201.3 Terms and definitions .5
201.4 General requirements.9
201.5 General requirements for testing ME EQUIPMENT .11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .17
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions.24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .24
201.15 Construction of ME EQUIPMENT.25
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS.26
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS.26
201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM .32
201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM.39
201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM.43
201.105 Additional requirements for an ANAESTHETIC VENTILATOR.47
201.105.7 * Timed ventilatory pause .50
201.105.7.1 Expiratory pause .50
201.105.7.2 Inspiratory pause.50
201.106 Display loops.53
201.107 Clinical evaluation .53
202 Electromagnetic compatibility — Requirements and tests.54
203 General requirements for radiation protection in diagnostic X-ray equipment.54
206 Usability.54
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS .55
209 Requirements for environmentally conscious design .55
© ISO 2011 – All rights reserved iii

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-13:2011(E)
210 PROCESS requirements for the development of physiologic closed-loop controllers .56
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare.56
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME
SYSTEMS or their parts .57
Annex D (informative) Symbols on marking.67
Annex AA (informative) Particular guidance and rationale.69
Annex BB (normative) Test for flammability of anaesthetic agent .84
Annex CC (informative) Environmental aspects .85
Annex DD (informative) Reference to the essential principles.87
Bibliography .94
Alphabetized index of defined terms used in this particular standard .96

iv © ISO 2011 – All rights reserved

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 80601-2-13:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 80601-2-13 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines and Technical
Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical
equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.
This first edition of ISO 80601-2-13 cancels and replaces the following:
⎯ ISO 8835-2:2007, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems
⎯ ISO 8835-3:2007, Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
⎯ ISO 8835-4:2004, Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices
⎯ ISO 8835-5:2004, Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators
⎯ IEC 60601-2-13:2003, Medical electrical equipment — Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
This edition constitutes a major technical revision of the material that was contained in the previous standards
by consolidating it into a single document, removing duplications and inconsistencies as well as harmonization
with the third edition of IEC 60601-1.
© ISO 2011 – All rights reserved v

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SIST EN ISO 80601-2-13:2013
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-13:2011(E)
Introduction
In this International Standard, the following print types are used:
⎯ Requirements and definitions: roman type.
⎯ Test specifications: italic type.
⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
⎯ Terms defined in Clause 3 of the general standard, in this particular standard or as noted: small capitals.
In referring to the structure of this standard, the term
⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
⎯ “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular standard are by number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
committee that the content of this publication not be adopted for mandatory implementation nationally earlier
than 3 years from the date of publication for equipment newly designed and no
...