SIST EN 60601-2-8:2015/A1:2016

Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010/A1:2015)

2015-09-16 - IEC inform CCMC that FDIS should be cancelled since the amendment will skip FDIS and go straight to publication

Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV

Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

Medicinska električna oprema - 2-8. del: Posebne zahteve za osnovno varnost in bistvene lastnosti terapevtske rentgenske opreme, ki deluje v območju od 10 kV do 1 MV - Dopolnilo A1 (IEC 60601-2-8:2010/A1:2015)

General Information

• Status: Published
• Publication Date: 08-Feb-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: 25-Jan-2016
• Due Date: 31-Mar-2016
• Completion Date: 09-Feb-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 60601-2-8:2015/A1:2016 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Relations

• Amends: SIST EN 60601-2-8:2015 - Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 06-Aug-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-8:2015/A1:2016
01-marec-2016
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLWHUDSHYWVNHUHQWJHQVNHRSUHPHNLGHOXMHYREPRþMXRGN9
GR09'RSROQLOR$,(&$
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and
essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1
MV (IEC 60601-2-8:2010/A1:2015)
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen
im Bereich von 10 kV bis 1 MV
Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de thérapie
fonctionnant dans la gamme de 10 kV à 1 MV
Ta slovenski standard je istoveten z: EN 60601-2-8:2015/A1:2016
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-8:2015/A1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-8:2015/A1:2016

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SIST EN 60601-2-8:2015/A1:2016


EUROPEAN STANDARD EN 60601-2-8:2015/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
January 2016
ICS 11.040.50

English Version
Medical electrical equipment - Part 2-8: Particular requirements
for the basic safety and essential performance of therapeutic
X-ray equipment operating in the range 10 kV to 1 MV
(IEC 60601-2-8:2010/A1:2015)
Appareils électromédicaux - Partie 2-8: Exigences Medizinische elektrische Geräte - Teil 2-8: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de thérapie wesentlichen Leistungsmerkmale von Therapie-
fonctionnant dans la gamme de 10 kV à 1 MV Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
(IEC 60601-2-8:2010/A1:2015) (IEC 60601-2-8:2010/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-8:2015; it was approved by CENELEC on 2015-11-03. 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 60601-2-8:2015/A1:2016 E

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SIST EN 60601-2-8:2015/A1:2016
EN 60601-2-8:2015/A1:2016
European foreword
The text of document 62C/593/CDV, future IEC 60601-2-8:2010/A1, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry", of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 60601-2-8:2015/A1:2016.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-08-03
national level by publication of an identical national
standard or by endorsement
(dow) 2018-11-03
• 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, included in EN 60601-2-8:2015.
Endorsement notice
The text of the International Standard IEC 6
...