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SIST EN 60601-2-33:2010/A12:2017

(Amendment)

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

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

Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Magnetresonanzgeräten für die medizinische Diagnostik

Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical

Medicinska električna oprema - 2-33. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za magnetno resonanco za medicinsko diagnostiko - Dopolnilo A12

General Information

Status
Published
Publication Date
29-Nov-2016
ICS
11.040.55 - Diagnostic equipment
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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 60601-2-33:2010/A12:2016 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Relations

Amends
SIST EN 60601-2-33:2010 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
Effective Date
15-Nov-2016

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EN 60601-2-33:2010/A12:2017
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-33:2010/A12:2017
01-januar-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DPDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR
'RSROQLOR$
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical diagnosis
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Magnetresonanzgeräten für die
medizinische Diagnostik
Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à résonance magnétique utilisés pour le
diagnostic médical
Ta slovenski standard je istoveten z: EN 60601-2-33:2010/A12:2016
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-33:2010/A12:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-33:2010/A12:2017

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

SIST EN 60601-2-33:2010/A12:2017


EUROPEAN STANDARD EN 60601-2-33:2010/A12

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2016
ICS 11.040.55

English Version
Medical electrical equipment - Part 2-33: Particular requirements
for the basic safety and essential performance of magnetic
resonance equipment for medical diagnosis
Appareils électromédicaux - Partie 2-33: Exigences Medizinische elektrische Geräte - Teil 2-33: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à résonance magnétique utilisés wesentlichen Leistungsmerkmale von
pour le diagnostic médical Magnetresonanzgeräten für die medizinische Diagnostik
This amendment A12 modifies the European Standard EN 60601-2-33:2010; 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 60601-2-33:2010/A12:2016 E

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SIST EN 60601-2-33:2010/A12:2017
EN 60601-2-33:2010/A12:2016
European foreword
This document (EN 60601-2-33:2010/A12:2016) 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 60601-2-33:2010/A12:2017
EN 60601-2-33:2010/A12:2016
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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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