DS/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

Standard No.

DS/EN 60601-2-31:2008

Release Date

2008

Published By

Danish Standards Foundation

Status

Be replaced 2011-10

Replace By

DS/EN 60601-2-31/A1:2011

Latest

DS/EN 60601-2-31/A1:2011

Replace

DS/EN 60601-2-31-1997 DS/EN 60601-2-31/A1-1998

Scope

Subclause 1.1 of the general standard is replaced by:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.This standard applies to PATIENT CABLES as defined in 201.3.209. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT

DS/EN 60601-2-31:2008 history

• 2011 DS/EN 60601-2-31/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
• 2008 DS/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