ISO-14708-1 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO-14708-1 - 2ND EDITION - CURRENT
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ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices.

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.

ISO 14708-1:2014 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).

ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

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11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ISO 14708-1:2014

Revision Level

2ND EDITION

Status

Current

Publication Date

Aug. 15, 2014

Committee Number

ISO/TC 150/SC 6