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EN 60601-1-3:2008/A11:2016

(Amendment)

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

D155/C032-C033: Publication of revised Annex ZA and Annex ZZ
2021: CLC legacy converted by DCLab NISOSTS

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten

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

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zaščita pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A11

General Information

Status
Published
Publication Date
17-Nov-2016
Withdrawal Date
31-Oct-2019
ICS
11.040.50 - Radiographic equipment
13.280 - Radiation protection
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
CLC/TC 62 - Electrical equipment in medical practice
Current Stage
6060 - Document made available - Publishing
Start Date
18-Nov-2016
Completion Date
18-Nov-2016
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
SIST EN 60601-1-3:2008/A11:2017 - 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
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
26-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-3:2008/A11:2017
01-januar-2017
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DãþLWDSUHGVHYDQMHPSULUHQWJHQVNL
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Medical electrical equipment - Part 1-3: General requirements for basic safety and
essential performance - Collateral Standard: Radiation protection in diagnostic X-ray
equipment
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten
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
Ta slovenski standard je istoveten z: EN 60601-1-3:2008/A11:2016
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-1-3:2008/A11:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1-3:2008/A11:2017

---------------------- Page: 2 ----------------------

SIST EN 60601-1-3:2008/A11:2017


EUROPEAN STANDARD EN 60601-1-3:2008/A11

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2016
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
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
This amendment A11 modifies the European Standard EN 60601-1-3:2008; it was approved by CENELEC on 2016-11-01. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-3:2008/A11:2016 E

---------------------- Page: 3 ----------------------

SIST EN 60601-1-3:2008/A11:2017
EN 60601-1-3:2008/A11:2016
European foreword
This document (EN 60601-1-3:2008/A11:2016) has been prepared by CLC/TC 62 "Electrical
equipment in medical practice".
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2017-11-01
national level by publication of an identical national
standard or by endorsement
(dow) 2019-11-01
• latest date by which the national standards conflicting with
the 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 [and/or CEN] 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, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
2

---------------------- Page: 4 ----------------------

SIST EN 60601-1-3:2008/A11:2017
EN 60601-1-3:2008/A11:2016
1 Modifications to annexes
Replace Annex ZA and Annex ZZ with the following.
Anne
...

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