This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.
The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.
This part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this particular standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified.