EN 60601-1-9:2008/A2:2020

SLOVENSKI STANDARD
01-november-2020
Medicinska električna oprema - 1-9. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Zahteve za okoljsko osveščeno
snovanje - Dopolnilo A2 (IEC 60601-1-9:2007/A2:2020)
Medical electrical equipment - Part 1-9: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for environmentally
conscious design (IEC 60601-1-9:2007/A2:2020)
Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
zur Reduzierung von Umweltauswirkungen (IEC 60601-1-9:2007/A2:2020)
Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Exigences pour une conception éco-
responsable (IEC 60601-1-9:2007/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1-9:2008/A2:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
13.020.01 Okolje in varstvo okolja na Environment and
splošno environmental protection in
general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-1-9:2008/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 11.040.01; 13.020.01
English Version
Medical electrical equipment - Part 1-9: General requirements for
basic safety and essential performance - Collateral Standard:
Requirements for environmentally conscious design
(IEC 60601-1-9:2007/A2:2020)
Appareils électromédicaux - Partie 1-9: Exigences Medizinische elektrische Geräte - Teil 1-9: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Exigences pour une wesentlichen Leistungsmerkmale - Ergänzungsnorm:
conception écoresponsable Anforderungen zur Reduzierung von Umweltauswirkungen
(IEC 60601-1-9:2007/A2:2020) (IEC 60601-1-9:2007/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1-9:2008; it was approved by CENELEC on 2020-08-26. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-9:2008/A2:2020 E

European foreword
The text of document 62A/1393/FDIS, future IEC 60601-1-9/A2, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-05-26
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-08-26
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 60601-1-9:2007/A2:2020 was approved by CENELEC as a
European Standard without any modification.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Replace the Annex ZA of EN 60601-1-9:2008 by the following one:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020 +A2 —
Under preparation. Stage at time of publication: EN 60601-1:2006/FprA2:2020.
IEC 60601-1-9 ®
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
...