Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

D155/C077: BT adopted the revised Annexes ZA and ZZ to EN 60601-1-8:2007 --> publication without TC proofing

Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen

Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux

Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih - Dopolnilo A11

General Information

Status
Published
Publication Date
16-Mar-2017
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
15-Mar-2017
Due Date
20-May-2017
Completion Date
17-Mar-2017

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 60601-1-8:2008/A11:2017
01-maj-2017
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SUHVNXãDQMHLQQDSRWNL]DDODUPQHVLVWHPHYPHGLFLQVNLHOHNWULþQLRSUHPLLQ
PHGLFLQVNLKHOHNWULþQLKVLVWHPLK'RSROQLOR$

Medical electrical equipment - Part 1-8: General requirements for basic safety and

essential performance - Collateral Standard: General requirements, tests and guidance

for alarm systems in medical electrical equipment and medical electrical systems

Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme -

Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen

elektrischen Geräten und in medizinischen elektrischen Systemen

Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et

les performances essentielles - Norme collatérale: Exigences générales, essais et guide

pour les systèmes d'alarme des appareils et des systèmes électromédicaux
Ta slovenski standard je istoveten z: EN 60601-1-8:2007/A11:2017
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-8:2008/A11:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-1-8:2008/A11:2017
---------------------- Page: 2 ----------------------
SIST EN 60601-1-8:2008/A11:2017
EUROPEAN STANDARD EN 60601-1-8:2007/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2017
ICS 11.040.01
English Version
Medical electrical equipment -
Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment
and medical electrical systems
Appareils électromédicaux - Medizinische elektrische Geräte -

Partie 1-8: Exigences générales pour la sécurité de base et Teil 1-8: Allgemeine Festlegungen für die Sicherheit

les performances essentielles - Norme collatérale: einschließlich der wesentlichen Leistungsmerkmale -

Exigences générales, essais et guide pour les systèmes Ergänzungsnorm: Alarmsysteme - Allgemeine

d'alarme des appareils et des systèmes électromédicaux Festlegungen, Prüfungen und Richtlinien für Alarmsysteme

in medizinischen elektrischen Geräten und in medizinischen
elektrischen Systemen

This amendment A11 modifies the European Standard EN 60601-1-8:2007; it was approved by CENELEC on 2017-01-07. 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, 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: Avenue Marnix 17, B-1000 Brussels

© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-1-8:2007/A11:2017 E
---------------------- Page: 3 ----------------------
SIST EN 60601-1-8:2008/A11:2017
EN 60601-1-8:2007/A11:2017
European foreword

This document (EN 60601-1-8:2007/A11:2017) has been prepared by CLC/TC 62 "Electrical

equipment in medical practice".
The following dates are fixed:
• latest date by which this document has
(dop) 2018-07-01
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national
(dow) 2020-01-07
standards conflicting with this
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.

For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this

document.
---------------------- Page: 4 ----------------------
SIST EN 60601-1-8:2008/A11:2017
EN 60601-1-8:2007/A11:2017
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", t
...

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