EN 60601-2-31:2008

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-31:2008 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1994 and its Amendment 1 (1998). This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains minimal technical revisions from the first edition.

Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit interner Stromversorgung

Appareils électromédicaux - Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne

La CEI 60601-2-31:2008 s'applique à la sécurité de base et aux performances essentielles des stimulateurs externes alimentés par une source d'énergie électrique interne. Les exigences minimales de sécurité spécifiées dans la présente norme particulière sont considérées comme assurant un degré pratique de sécurité dans le fonctionnement des stimulateurs cardiaques externes à source d'énergie interne. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette deuxième édition annule et remplace la première édition publiée en 1994 et son Amendement 1 (1998). Cette deuxième édition de la CEI 60601-2-31 est structurée selon la CEI 60601-1:2005 et apporte des modifications techniques mineures par rapport à la première édition.

Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom (IEC 60601-2-31:2008)

General Information

• Status: Withdrawn
• Publication Date: 24-Jul-2008
• Withdrawal Date: 31-May-2011
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Apr-2023
• Completion Date: 03-Apr-2023
• 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 60601-2-31:2008 - Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Relations

• Replaces: EN 60601-2-31:1995 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-31:1995/A1:1998 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Replaced By: EN IEC 60601-2-31:2020 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 07-Apr-2020
• Amended By: EN 60601-2-31:2008/A1:2011 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-31:2008
01-november-2008
1DGRPHãþD
SIST EN 60601-2-31:1995
SIST EN 60601-2-31:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]XQDQMLKVUþQLKVSRGEXMHYDOQLNRY]YJUDMHQLPQDSDMDOQLPYLURP
,(&
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and
essential performance of external cardiac pacemakers with internal power source (IEC
60601-2-31:2008)
Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit
interner Stromversorgung (IEC 60601-2-31:2008)
Appareils électromédicaux - Partie 2-31: Regles particulieres de sécurité de base et de
performances essentielles des stimulateurs cardiaques externes a source d'énergie
interne (CEI 60601-2-31:2008)
Ta slovenski standard je istoveten z: EN 60601-2-31:2008
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-2-31:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-31:2008

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

SIST EN 60601-2-31:2008

EUROPEAN STANDARD
EN 60601-2-31

NORME EUROPÉENNE
July 2008
EUROPÄISCHE NORM

ICS 11.040.01 Supersedes EN 60601-2-31:1995 + A1:1998


English version


Medical electrical equipment -
Part 2-31: Particular requirements for the basic safety
and essential performance of external cardiac pacemakers
with internal power source
(IEC 60601-2-31:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-31: Exigences particulières Teil 2-31: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des stimulateurs cardiaques externes von externen Schrittmachern
à source d'énergie interne mit interner Stromversorgung
(CEI 60601-2-31:2008) (IEC 60601-2-31:2008)




This European Standard was approved by CENELEC on 2008-06-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
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 Central Secretariat or to any CENELEC member.

This European Standard 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-31:2008 E

---------------------- Page: 3 ----------------------

SIST EN 60601-2-31:2008
EN 60601-2-31:2008 - 2 -
Foreword
The text of document 62D/603/CDV, future edition 2 of IEC 60601-2-31, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-31 on 2008-06-01.
This European Standard supersedes EN 60601-2-31:1995 + A1:1998.
EN 60601-2-31:2008 is aligned with EN 60601-1:2006, and contains minimal technical revisions from
EN 60601-2-31:1995.
The following dates were fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2009-03-01
national standard or by endorsement

– latest date by which the national standards conflicting
(dow) 2011-06-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, exampl
...