EN 60601-2-13:2006

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

Superseded by EN ISO 80601-2-13:2012 (the DOW of which is 2015-12-31)

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

Appareils électromédicaux - Partie 2-13: Règles particulières de sécurité et performance essentielle pour les systèmes d'anesthésie

Medicinska električna oprema – 2-13. del: Posebne varnostne zahteve in bistvene lastnosti sistemov za anestezijo (IEC 60601-2-13:2003)

General Information

• Status: Withdrawn
• Publication Date: 27-Jun-2006
• Withdrawal Date: 30-Dec-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-Dec-2015
• Completion Date: 31-Dec-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-13:2006 - Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

Relations

• Amended By: EN 60601-2-13:2006/A1:2007 - Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI SIST EN 60601-2-13:2006

STANDARD
oktober 2006
Medicinska električna oprema – 2-13. del: Posebne varnostne zahteve in
bistvene lastnosti sistemov za anestezijo (IEC 60601-2-13:2003)
Medical electrical equipment – Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems (IEC 60601-2-13:2003)
ICS 11.040.10 Referenčna številka
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD
EN 60601-2-13
NORME EUROPÉENNE
June 2006
EUROPÄISCHE NORM
ICS 11.040.10
English version
Medical electrical equipment
Part 2-13: Particular requirements
for the safety and essential performance
of anaesthetic systems
(IEC 60601-2-13:2003)
Appareils électromédicaux  Medizinische elektrische Geräte
Partie 2-13: Règles particulières de Teil 2-13: Besondere Festlegungen
sécurité et performance essentielle für die Sicherheit von
pour les systèmes d'anesthésie Anästhesiesystemen
(CEI 60601-2-13:2003) (IEC 60601-2-13:2003)

This European Standard was approved by CENELEC on 2006-05-01. CENELEC 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 Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-13:2006 E
Foreword
The text of the International Standard IEC 60601-2-13:2003, prepared by SC 62D, Electromedical
equipment, of IEC TC 62, Electrical equipment in medical practice, and ISO TC 121/SC 1, Breathing
attachments and anaesthetic machines, was submitted to the Unique Acceptance Procedure and was
approved by CENELEC as EN 60601-2-13 on 2006-05-01.
The following dates were fixed:
- latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-05-01
- latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard partly replaces EN 740:1998, Anaesthetic workstations and their modules -
Particular requirements.
Other European Standards relating to anaesthetic workstations and their components prepared or in
preparation by CEN/TC215 which, when all published will together with EN 60601-2-13:2006 replace
EN 740:1998 in total, are:
– prEN ISO/DIS 8835-2:2005, Inhalational anaesthesia systems – Part 2: Anaesthetic breathing
systems for adults
– prEN ISO/DIS 8835-3.2:2005, Inhalational anaesthesia systems – Part 3: Transfer and receiving
systems of active anaesthetic gas scavenging systems
– EN ISO 8835-4:2004, Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery devices
– EN ISO 8835-5:2004, Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators
Attention is also drawn to ISO/TS 18835:2004, Inhalational anaesthesia systems — Draw-over vaporizers
and associated equipment.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD: SMALL
CAPITALS.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-13:2003 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 60601-2-13:2006
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60079-4 1975 Electrical apparatus for explosive gas - -
atmospheres
Part 4: Method of test for ignition temperature

IEC 60079-11 1999 Electrical apparatus for explosive gas -
-
atmospheres
Part 11: Intrinsic safety "i"
ISO 32 1977 Gas cylinders for medical use - Marking for - -
identification of content
ISO 407 1991 Small medical gas cylinders - Pin-index yoke-- -
type valve connections
ISO 3746 1995 Acoustics - Determination of sound power - -
levels of noise sources using sound pressure
Survey method using an enveloping
measurement surface over a reflecting plane

ISO 4135 2001 Anaesthetic and respiratory equipment - - -
Vocabulary
ISO 5145 1990 Cylinder valve outlets for gases and gas - -
mixtures - Selection and dimensioning

ISO 5356-1 1996 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 1: Cones and sockets
ISO 5356-2 1987 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 2: Screw-threaded weight-bearing
connectors
ISO 5359 2000 Low-pressure hose assemblies for use with - -
medical gas systems
ISO 5362 2000 Anaesthetic reservoir bags - -

ISO 7396-1 2002 Medical gas pipeline systems - -
Part 1: Pipelines for compressed medical
gases and vacuum
Publication Year Title EN/HD Year
1)
ISO 7767 1997 Oxygen monitors for monitoring patient - -
breathing mixtures - Safety requirements

ISO 8835-2 1999 Inhalational anaesthesia systems - -
Part 2: Anaesthetic breathing systems for
adults
ISO 8835-3 1997 Inhalational anaesthesia systems - -
Part 3: Anaesthetic gas scavenging systems -
Transfer and receiving 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

ISO 9170-1 1999 Terminal units for medical gas pipeline - -
systems
Part 1: Terminal units for use with
compressed medical gases and vacuum

2)
ISO 9703-1 1992 Anaesthesia and respiratory care alarm - -
signals
Part 1: Visual alarm signals
2)
ISO 9703-2 1994 Anaesthesia and respiratory care alarm - -
signals
Part 2: Auditory alarm signals

2)
ISO 9703-3 1998 Anaesthesia and respiratory care alarm - -
signals
Part 3: Guidance on application of alarms

1)
ISO 9918 1993 Capnometers for use with humans - - -
Requirements
3)
ISO 10524 1995 Pressure regulators and pressure regulators - -
with flow-metering devices for medical gas
systems
1)
ISO 11196 1995 Anaesthetic gas monitors - -

ISO 15223 2000 Medical devices - Symbols to be used with - -
medical device labels, labelling and
information to be supplied
1)
ISO 7767:1997, ISO 9918:1993 and ISO 11196:1995 are superseded by ISO 21647:2004, which is harmonized as
EN ISO 21647:2004, Medical electrical equipment -- Particular requirements for the basic safety and essential performance of
respiratory gas monitors.
2)
The ISO 9703 series is superseded by IEC 60601-1-8:2003, which is harmonized as EN 60601-1-8:2004.
3)
ISO 10524:1995 is superseded by ISO 10524-1:2006, which is harmonized as EN ISO 10524-1:2006, Pressure regulators for use
with medical gases -- Part 1: Pressure regulators and pressure regulators with flow-metering devices.

- 5 - EN 60601-2-13:2006
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
INTERNATIONAL IEC
STANDARD
60601-2-13
Third edition
2003-05
Medical electrical equipment –
Part 2-13:
Particular requirements for the safety and
essential performance of anaesthetic systems
Appareils électromédicaux –
Partie 2-13:
Règles particulières de sécurité et
performance essentielle pour les systèmes d’anesthésie
 IEC 2003
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 the publisher.
IEC Copyright Office Case postale 56 CH-1211 Genève 20 Switzerland
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PRICE CODE
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For price, see current catalogue

– 2 – 60601-2-13  IEC:2003(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
SECTION ONE – GENERAL
1 Scope and object . 7
2 Terminology and definitions .10
3 General requirements .12
4 General requirements for tests.12
6 Identification, marking and documents .12
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
*43 Fire prevention .18
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization
and disinfection .18
49 Interruption of the POWER SUPPLY .19
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output .19
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
52 Abnormal opertion and fault conditions .23
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General .24
56 Components and general assembly .24
57 MAINS PARTS, components and layout.24

60601-2-13  IEC:2003(E) – 3 –
SECTION 101 – ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS
DELIVERY SYSTEMS
101 Medical gas supply.25
102 Medical gas pipeline inlet connections .25
103 Medical gas supply pressure monitoring.26
104 Medical gas supply PRESSURE REGULATORs.26
105 Anaesthetic gas delivery system piping .26
106 Gas flow metering .27
107 Gas mixer .28
108 Oxygen flush.29
109 Fresh gas outlet .29
110 Checklist.
...