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)

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

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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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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

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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.
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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
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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;
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)
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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
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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)
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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
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.
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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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ISO 80601-2-13:2011(E)
©  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
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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
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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

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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.
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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 not earlier than 5 years from the
date of publication for equipment already in production.
This International Standard considers both an ANAESTHETIC WORKSTATION supplied complete and its individual
components. It has been structured to allow RESPONSIBLE ORGANIZATIONS to configure an ANAESTHETIC
WORKSTATION from individual components in conformance with professional guidelines and to meet the needs
of their clinical practice. In order to achieve this aim, this International Standard identifies particular
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ISO 80601-2-13:2011(E)
requirements pertinent to specific ANAESTHETIC WORKSTATION components, and to their associated MONITORING
EQUIPMENT, ALARM SYSTEM(S) and PROTECTION DEVICE(S), and defines the interfaces.
Figure 201.101 is a graphical representation of the structure of this International Standard and is provided for
informational purposes only.
ANAESTHETIC WORKSTATION
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-211
MONITORING EQUIPMENT,
Mandatory elements;
ALARM SYSTEMS and
ANAESTHETIC GAS DELIVERY SYSTEM
see also Table AA.1
Clause 201.101 PROTECTION DEVICES
ANAESTHETIC BREATHING SYSTEM
Clause 201.102
ANAESTHETIC GAS SCAVENGING SYSTEM
Clause 201.103
MONITORING EQUIPMENT,
ANAESTHETIC VAPOUR DELIVERY SYSTEM Optionally present;
ALARM SYSTEMS and
see also Table AA.1
Clause 201.104
PROTECTION DEVICES
ANAESTHETIC VENTILATOR
Clause 201.105
Figure 201.101 — Configuration of an ANAESTHETIC WORKSTATION and corresponding organization of
this International Standard
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INTERNATIONAL STANDARD ISO 80601-2-13:2011(E)

Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC
WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional
.
OPERATOR
This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the
following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their
own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form
an ANAESTHETIC WORKSTATION to a given specification:
⎯ ANAESTHETIC GAS DELIVERY SYSTEM;
⎯ ANAESTHETIC BREATHING SYSTEM;
⎯ ANAESTHETIC GAS SCAVENGING SYSTEM;
⎯ ANAESTHETIC VAPOUR DELIVERY SYSTEM;
⎯ ANAESTHETIC VENTILATOR;
⎯ MONITORING EQUIPMENT;
⎯ ALARM SYSTEM;
⎯ PROTECTION DEVICE.
NOTE 1 MONITORING EQUIPMENT, ALARM SYSTEMS and PROTECTION DEVICES are summarized in Table AA.1.
An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME
EQUIPMENT or ME SYSTEMS with regard to the general standard.
NOTE 2 The applicability of this International Standard is indicated in Table AA.2.
This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect the
BASIC SAFETY and ESSENTIAL PERFORMANCE of the ANAESTHETIC WORKSTATION.
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If a clause or subclause is specifically intended to be applicable to ANAESTHETIC WORKSTATION components
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
subclause applies both to an ANAESTHETIC WORKSTATION and its individual components, as relevant.
HAZARDS inherent in the intended physiological function of an ANAESTHETIC WORKSTATION and its individual
components within the scope of this International Standard are not covered by specific requirements in this
International Standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.
This International Standard is not applicable to any ANAESTHETIC WORKSTATION intended for use with
flammable anaesthetic agents, as determined by Annex BB.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for an ANAESTHETIC WORKSTATION and its individual components designed for use in the
ANAESTHETIC WORKSTATION (as defined in 201.3.211) and its ACCESSORIES.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and Clause 201.2 of this particular standard.
IEC 60601-1-3:2008 and IEC 60601-1-11:2010 do not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
general standard and collateral standards, as appropriate for the particular ME EQUIPMENT under consideration,
and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 is referred to in this particular standard as the general standard. Collateral
standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general
standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general
standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-2 collateral standard, 206.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-6 collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:
“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is
replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of the general
standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this particular standard.
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Subclauses, figures or tables which are additional to those of the general standard are numbered starting from
201.101. However, due to the fact that definitions in the general standard are numbered 3.1 to 3.139,
additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered
AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x,
where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for IEC 60601-1-6, etc.
The term “this standard” is used to make reference to the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of
the general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
IEC 60601-1:2005, Clause 2 applies, except as follows:
Replacement:
Replace references to ISO 2878, ISO 15223, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 by the following:
ISO 2878:2005, Rubber — Antistatic and conductive products — Determination of electrical resistance
1)
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied — Part 1: General requirements
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
Addition:
ISO 407:2004, Small medical gas cylinders — Pin-index yoke-type valve connections [alternative normative
reference to ISO 5145]
2)
ISO 594-2:1998 , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

1) To be published.
2) To be revised by ISO 80369-7, Small bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors with 6% (Luer) taper for intravascular or hypodermic applications, which is under preparation.
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ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning [alternative
normative reference to ISO 407]
ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2006, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 5359:2008, Low-pressure hose assemblies for use with medical gases
ISO 5360:2006, Anaesthetic vaporizers — Agent-specific filling systems
ISO 5362:2006, Anaesthetic reservoir bags
ISO 5367:2000, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
ISO 8836, Suction catheters for use in the respiratory tract
ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 9170-2, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas
scavenging systems
ISO 10079-1, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety
requirements [alternative normative reference to ISO 10079-3]
ISO 10079-3, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure
source [alternative normative reference to ISO 10079-1]
ISO 10524-1:2006, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
3)
ISO 80601-2-55:— , Medical electrical equipment — Part 2-55: Particular requirements for the basic safety
and essential performance of respiratory gas monitors
IEC 60079-11, Explosive atmospheres — Part 11: Equipment protection by intrinsic safety "i"
IEC 60079-20-1, Explosive atmospheres — Part 20-1: Material characteristics for gas and vapour
classification — Test methods and data
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability

3) To be published.
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ISO 80601-2-13:2011(E)
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requiremen
...