EVS-EN 45502-2-1:2004

This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. 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 2-1 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 Part 2-1 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1 shall apply.