Active implantable medical devices - General requirements for safety, marking and information to be provided by the manufacturer

Active implantable medical devices - General requirements for safety, marking and information to be provided by the manufacturer

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1   Scope

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 parts and accessories of the devices (see note 1).

NOTE 1. The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2. The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.

NOTE 3. In this European Standard, terms printed in small capital letters are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.