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IEC 60601-2-31 External Cardiac Pacemakers with Internal Power Source Testing

Medical electrical equipment – Part 2-31: the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-31 Scope:

IEC 60601 2 31 and EN 60601 2 31 testing applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source, hereafter referred to as medical electronic equipment.

IEC 60601-2-31 applies to patient cables as defined in 201.3.109, but does not apply to leads as defined in 201.3.106.

Hazards inherent in the intended physiological function of medical electronic 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.

EN 60601-2-31 does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 IEC 60601-2-31 testing 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 medical electronic equipment and antitachycardia medical electronic equipment.

Keystone Compliance assists manufacturers with IEC 60601-2-31 and EN 60601-2-31 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-31 test lab needs.