EN 60601-2-13:2006
(Main)Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
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Superseded by EN ISO 80601-2-13:2012 (the DOW of which is 2015-12-31)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
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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
SIST EN 60601-2-13:2006(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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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
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EN 60601-2-13:2006 - 2 -
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.
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