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

D155/C032-C033: Publication of revised Annex ZA and Annex ZZ

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: 29-Nov-2016
• 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: 23-Nov-2016
• Due Date: 28-Jan-2017
• Completion Date: 30-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: EN 60601-1-3:2008/A11:2016 - 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: 15-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-3:2008/A11:2017
01-januar-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DãþLWDSUHGVHYDQMHPSULUHQWJHQVNL
GLDJQRVWLþQLRSUHPL'RSROQLOR$
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.

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

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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

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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

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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.
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
However, for any use of this standard “within the meaning of Annex ZZ", the user must always check
that any referenced document has not been superseded and that its relevant contents can still be
considered the generally acknowledged state-of-art.
When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a
normative reference to the parallel EN standard, as outlined below, including the foreword and the
Annexes ZZ.
NOTE 1 The way in which referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
NOTE 2 When an international publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
Publication Year Title EN/HD Year
IEC 60336 Medical electrical equipment - X-ray EN 60336 2005
tube assemblies for medical use -
Characteristics of focal spots
IEC 60522 1999 Determination of the permanent filtration EN 60522 1999
of X-ray tube assemblies
IEC 60601-1 2005 Medical electrical equipment EN 60601-1 2006
Part 1: General requirements for basic
A1 2012 EN 60601-1/A1 2013
safety and essential performance
 EN 60601-1/A12 2014
IEC 60788 2004 Medical electrical equipment - Glossary
of defined terms
ISO 497 Guide to the choice of series of
preferred numbers and of series
containing more rounded values of
preferred numbers

3

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SIST EN 60601-1-3:2008/A11:2017
EN 60601-1-3:2008/A11:2016
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to the
Essential Requirements given in Annex I of EU Directive 93/42/EEC.
General Guidance:
Once this standard will be cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope
of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of
that Directive and associated EFTA regulations.
NOTE 1 The standard’s scope is limited to the specific uses, environments, contexts, objective situations
specifically indicated. It cannot provide for presumption of conformity in other conditions. Some clauses or
subclauses may be not applicable due to the specific type of equipment under consideration.
NOTE 2 Only prescriptions contained in the normative parts of the text are relevant to the presumption of
conformity of this standard. Informative parts may, however, support users to interpret such prescriptions
correctly.
NOTE 3 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC. This means that risks have to be
reduced "as far as possible", "to a minimum", "to the lowest possible level", "minimized" or "removed", according
to the wording of the corresponding essential requirement which must be interpreted and applied in such a way as
to take account of technology and practice existing at the time of design and of technical and economical
considerations compatible with a high level of protection of health and safety.
NOTE 4
...