SIST EN ISO 80601-2-13:2013/A2:2020

SLOVENSKI STANDARD
01-februar-2020
Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A2 (ISO 80601-2-
13:2011/Amd 2:2018)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-
13:2011/Amd 2:2018)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen -
Änderung 2 (ISO 80601-2-13:2011/Amd 2:2018)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie - Amendement 2
(ISO 80601-2-13:2011/Amd 2:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012/A2:2019
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.

EN ISO 80601-2-
EUROPEAN STANDARD
13:2012/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2019
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation - Amendment 2 (ISO 80601-2-
13:2011/Amd 2:2018)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les postes de travail d'anesthésie - wesentlichen Leistungsmerkmale für Anästhesie-
Amendement 2 (ISO 80601-2-13:2011/Amd 2:2018) Arbeitsplätzen - Änderung 2 (ISO 80601-2-
13:2011/Amd 2:2018)
This amendment A2 modifies the European Standard EN ISO 80601-2-13:2012; it was approved by CEN on 4 November 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-13:2012/A2:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-13:2012/A2:2019) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 80601-2-13:2012 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by May
2020, and conflicting national standards shall be withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2011/Amd 2:2018 has been approved by CEN as EN ISO 80601-2-
13:2012/A2:2019 without any modification.
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