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IEC 60601-2-31

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

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Organization: IEC
Publication Date: 1 June 2011
Status: inactive
Page Count: 22
ICS Code (Medical equipment in general): 11.040.01
scope:

Addition:

This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, powered by an INTERNAL ELECTRICAL POWER SOURCE.

This Standard applies to PATIENT CABLES as defined in 2.1.104.

This Standard does not apply to EQUIPMENT which can be directly or indirectly connected to a SUPPLY MAINS.

This Standard does not apply to pacing LEADS, or other equipment for cardiac stimulation which either:

1) forms an integral part of equipment with other functions; or

2) applies the stimulus across the thorax externally or in the oesophagus; or

3) provides antitachycardia therapy beyond high rate burst pacing; or

4) provides pacing system analysis functions.

Each of the two channels of DUAL CHAMBER EQUIPMENT is subject to the requirements of this Standard.

Document History

January 1, 2020
Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
This part of IEC 60601 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...
September 1, 2011
Medical electrical equipment – Part 2-31: Particular requirements for the 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...
IEC 60601-2-31
June 1, 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
Addition: This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, powered by an...
March 1, 2008
Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Addition: This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, powered by an...
October 1, 1994
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source
Addition: This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, powered by an...
January 1, 1994
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source; (CENELEC EN 60601-2-31: 1995) (AS/NZS 3200.2.31: 1996)
A description is not available for this item.

References

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