IEC 60601-2-31:2008 Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
Replacement:
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. 109.
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 within the scope of
this standard are not covered by specific requirements in this standard except in 7.2.13 and
8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard does not apply to the implantable parts of active implantable medical devices
covered by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be
connected directly or indirectly to a SUPPLY MAINS.
This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and
antitachycardia ME EQUIPMENT.
IEC 60601-2-31:2008 Referenced Document
ANSI/AAMI PC69-2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
IEC 60601-2-31:2008 history
0000 IEC 60601-2-31:2020 RLV
2011IEC 60601-2-31:2008/AMD1:2011 Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
2011IEC 60601-2-31:2011 Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
2008IEC 60601-2-31:2008 Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
1998IEC 60601-2-31:1994/AMD1:1998 Amendment 1 — Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
1994IEC 60601-2-31:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source