SIST EN IEC 60601-1-3:2008/A2:2021

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008/A2:2021)

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten (IEC 60601-1-3:2008/A2:2021)

Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic (IEC 60601-1-3:2008/A2:2021)

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A2 (IEC 60601-1-3:2008/A2:2021)

General Information

• Status: Published
• Publication Date: 13-Apr-2021
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Mar-2021
• Due Date: 24-May-2021
• Completion Date: 14-Apr-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: EN 60601-1-3:2008/A2:2021 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Relations

• Amends: SIST EN 60601-1-3:2008 - Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 30-Jun-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-1-3:2008/A2:2021
01-maj-2021
Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski
diagnostični opremi - Dopolnilo A2 (IEC 60601-1-3:2008/A2:2021)
Medical electrical equipment - Part 1-3: General requirements for basic safety and
essential performance - Collateral Standard: Radiation protection in diagnostic X-ray
equipment (IEC 60601-1-3:2008/A2:2021)
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten (IEC 60601-1-3:2008/A2:2021)
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Radioprotection dans les appareils à
rayonnement X de diagnostic (IEC 60601-1-3:2008/A2:2021)
Ta slovenski standard je istoveten z: EN 60601-1-3:2008/A2:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN IEC 60601-1-3:2008/A2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-1-3:2008/A2:2021


EUROPEAN STANDARD EN 60601-1-3:2008/A2

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2021
ICS 11.040.50; 13.280

English Version
Medical electrical equipment - Part 1-3: General requirements for
basic safety and essential performance - Collateral Standard:
Radiation protection in diagnostic X-ray equipment
(IEC 60601-1-3:2008/A2:2021)
Appareils électromédicaux - Partie 1-3: Exigences Medizinische elektrische Geräte - Teil 1-3: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Radioprotection dans les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils à rayonnement X de diagnostic Strahlenschutz von diagnostischen Röntgengeräten
(IEC 60601-1-3:2008/A2:2021) (IEC 60601-1-3:2008/A2:2021)
This amendment A2 modifies the European Standard EN 60601-1-3:2008; it was approved by CENELEC on 2021-03-02. 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 60601-1-3:2008/A2:2021 E

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SIST EN IEC 60601-1-3:2008/A2:2021
EN 60601-1-3:2008/A2:2021 (E)
European foreword
The text of document 62B/1176/CDV, future IEC 60601-1-3/A2, prepared by SC 62B “Diagnostic
imaging equipment” of IEC/TC 62 “Electrical equipment in medical practice” was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN 60601-1-3:2008/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021–12–02
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–03–02
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.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60601-1-3:2008/A2:2021 was approved by CENELEC as a
European Standard without any modification.
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SIST EN IEC 60601-1-3:2008/A2:2021
EN 60601-1-3:2008/A2:2021 (E)
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 existing reference to EN 60601-1 with the following:
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 2010
Mar.
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  - -

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SIST EN IEC 60601-1-3:2008/A2:2021



IEC 60601-1-3

®


Edition 2.0 2021-01




INTERNATIONAL



STANDARD




NORME


INTERNATIONALE




A MENDMENT 2

AM ENDEMENT 2





Medical electrical equipment –

Part 1-3: General requirements for basic safety and essential performance –

Collateral Standard: Radiation protection in diagnostic X-ray equipment



Appareils électromédicaux –

Partie 1-3: Exigences générales pour la sécurité de base et les pe
...