EN 60601-1-8:2007/A1:2013

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

2013-01-29: Publication allocated to [e-mail]

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 A1 (IEC 60601-1-8:2006/A1:2012)

General Information

• Status: Published
• Publication Date: 21-Mar-2013
• Withdrawal Date: 30-Dec-2018
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-Mar-2013
• Completion Date: 22-Mar-2013
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 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/A1:2014 - 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: 29-Jan-2023
• Corrected By: EN 60601-1-8:2007/A1:2013/AC:2014 - 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: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-8:2008/A1:2014
01-februar-2014
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/A1:2013
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-8:2008/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-8:2008/A1:2014

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SIST EN 60601-1-8:2008/A1:2014

EUROPEAN STANDARD
EN 60601-1-8/A1

NORME EUROPÉENNE
March 2013
EUROPÄISCHE NORM

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
(IEC 60601-1-8:2006/A1:2012)

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Exigences générales pour la Teil 1-8: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Exigences générales, Ergänzungsnorm: Alarmsysteme -
essais et guide pour les systèmes Allgemeine Festlegungen, Prüfungen und
d'alarme des appareils et des systèmes Richtlinien für Alarmsysteme in
électromédicaux medizinischen elektrischen Geräten und in
(CEI 60601-1-8:2006/A1:2012) medizinischen elektrischen Systemen
(IEC 60601-1-8:2006/A1:2012)


This amendment A1 modifies the European Standard EN 60601-1-8:2007; it was approved by CENELEC on
2013-01-02. 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.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2007/A1:2013 E

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SIST EN 60601-1-8:2008/A1:2014
EN 60601-1-8:2007/A1:2013 - 2 -
Foreword
The text of document 62A/824/FDIS, future edition 1 of IEC 60601-1-8:2006/A1, prepared by SC 62A,
"Common aspects of electrical equipment used in medical practice", of IEC/TC 62, "Electrical equipment
in medical practice" and ISO SC 3, "Lung ventilators and related devices" of ISO/TC 121, "Anaesthetic
and respiratory equipment" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-1-8:2007/A1:2013.

The following dates are fixed:
(dop) 2013-10-02
• latest date by which the document has
to be implem
...