BS EN 60601-2-31:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Section 2.31 Specification for external cardiac pacemakers with internal power source
Withdrawn
Printed version of this is available at library. To request, please e-mail to referencepk@usm.my and include a copy of this record in your e-mail.
BS EN 60601-2-31:1995 is a European standard that specifies the safety requirements and testing methods for external cardiac pacemakers. Cardiac pacemakers are medical devices that are used to regulate the heartbeat of patients who have an irregular or slow heartbeat.
The standard covers several aspects of safety, including electrical safety, mechanical safety, and fire safety. It also specifies requirements for electromagnetic compatibility, user safety, and performance. The standard provides guidance on the testing procedures for these safety requirements.
In addition, the standard specifies requirements for the labeling and documentation of external cardiac pacemakers, including information on their safety features and operating instructions.
It is important to note that this standard has been superseded by the updated version, EN 60601-2-47:2012. This newer version includes additional safety requirements and updated testing procedures to reflect advances in technology and changes in industry practices.
This clause of the General Standard applies, except as follows:
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.
BS EN 60601-2-31:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Section 2.31 Specification for external cardiac pacemakers with internal power source
