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

Publication date:   Feb 27, 2009

General information

99.60 Withdrawal effective   Apr 3, 2023

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.01   Medical equipment in general

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-31:1995

WITHDRAWN
EN 60601-2-31:1995/A1:1998

NOW

WITHDRAWN
EN 60601-2-31:2008
99.60 Withdrawal effective
Apr 3, 2023

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 60601-2-31:2008/A1:2011

REVISED BY

PUBLISHED
EN IEC 60601-2-31:2020