EN 60601-1-8:2007/A11:2017

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
2021: CLC legacy converted by DCLab NISOSTS

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: 09-Mar-2017
• Withdrawal Date: 06-Jan-2020
• ICS: 11.040.01 - Medical equipment in general
• 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: 10-Mar-2017
• Completion Date: 10-Mar-2017
• 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 60601-1-8:2008/A11:2017 - 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

Relations

• Amends: EN 60601-1-8:2007 - 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
• Effective Date: 24-Jan-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHWHKQLþQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG6SORãQH]DKWHYH
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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.
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
...