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SIST EN 60601-1:2007/A13:2024

(Amendment)

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

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 varnost - Dopolnilo A13

General Information

Status
Published
Publication Date
05-May-2024
ICS
11.040 - Medical equipment
11.040.01 - Medical equipment in general
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Apr-2024
Due Date
29-Jun-2024
Completion Date
06-May-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
EN 60601-1:2006/A13:2024 - Medical electrical equipment - Part 1: General requirements for safety

Relations

Amends
SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Effective Date
14-Feb-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1:2007/A13:2024
01-junij-2024
Medicinska električna oprema - 1. del: Splošne zahteve za varnost - Dopolnilo A13
Medical electrical equipment - Part 1: General requirements for safety
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
Ta slovenski standard je istoveten z: EN 60601-1:2006/A13:2024
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A13:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1:2007/A13:2024

---------------------- Page: 2 ----------------------
SIST EN 60601-1:2007/A13:2024


EUROPEAN STANDARD EN 60601-1:2006/A13

NORME EUROPÉENNE

EUROPÄISCHE NORM April 2024
ICS 11.040

English Version
Medical electrical equipment - Part 1: General requirements for
safety
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale
This amendment A13 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2024-02-28. 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,
Türkiye 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1:2006/A13:2024 E

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SIST EN 60601-1:2007/A13:2024
EN 60601-1:2006/A13:2024 (E)
Contents Page
European foreword . 3
1 Replacement of Annex ZA, Annex ZZA and Annex ZZB . 4
Annex ZA (normative) Normative references to international publications with their
corresponding European publications . 5
Annex ZZ (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 12
2

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SIST EN 60601-1:2007/A13:2024
EN 60601-1:2006/A13:2024 (E)
European foreword
This document (EN 60601-1:2006/A13:2024) has been prepared by CLC/TC 62 "Electrical Equipment in
medical practice".
The following dates are fixed:
• latest date by which this document has to be (dop) 2025-02-28
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2027-02-28
conflicting with this document have to be
withdrawn
This amendment A13 modifies EN 60601-1:2006, and EN 60601-1:2006/A1:2013 and
EN 60601-1:2006/A2:2021.
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.
This document has been prepared under a standardization request addressed to CENELEC by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part
...

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