Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale

Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)

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Status
Published
Publication Date
07-Oct-2021
Current Stage
6060 - Document made available - Publishing
Start Date
08-Oct-2021
Completion Date
08-Oct-2021

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SLOVENSKI STANDARD
SIST EN 60601-1:2007/A2:2021
01-december-2021
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in
bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005/A2:2020)
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles (IEC 60601-1:2005/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1:2006/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1:2007/A2:2021

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SIST EN 60601-1:2007/A2:2021


EUROPEAN STANDARD EN 60601-1:2006/A2

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2021
ICS 11.040.01

English Version
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
(IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Basissicherheit einschließlich der
(IEC 60601-1:2005/A2:2020) wesentlichen Leistungsmerkmale
(IEC 60601-1:2005/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2020-09-24. 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1:2006/A2:2021 E

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SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
European foreword
The text of document 62A/1389/FDIS, future IEC 60601-1/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
EN 60601-1:2006/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-04-08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-10-08
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-1:2005/A2:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-57 NOTE Harmonized as EN 60601-2-57
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
ISO 2409 NOTE Harmonized as EN ISO 2409
ISO 4624 NOTE Harmonized as EN ISO 4624
ISO 10524-1:2018 NOTE Harmonized as EN ISO 10524-1:2019 (not modified)
ISO 13732-1:2006 NOTE Harmonized as EN ISO 13732-1:2008 (not mo
...

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