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
|Publication Date:||1 June 2011|
|ICS Code (Medical equipment in general):||11.040.01|
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.