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

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

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1   Scope

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.

NOTE 1 For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular parts of ISO 14708.

The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.
This part of ISO 14708 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 ISO 14708 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

NOTE 2 The device that is commonly referred to as an active implantable medical device can 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 3 In this part of ISO 14708, 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.

NOTE 4 The terminology used in this part of ISO 14708 is intended to be consistent with the terminology of ISO/TR 14283:2004.