ÖNORM EN 45502-1

This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. 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 applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This Part of EN 45502 is also applicable to some non-implantable park and accessories of the devices (see note 1).