Standard ISO standard · ISO 14708-1:2014

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

Status: Valid

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Standard ISO standard · ISO 14708-1:2014

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

Subjects

Implants for surgery, prosthetics and orthotics (11.040.40)


Buy this standard

Standard ISO standard · ISO 14708-1:2014

Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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Price: 2 614 SEK
standard ikon pdf

PDF

Price: 2 614 SEK
standard ikon

Paper

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Product information

Language: English

Written by: ISO

International title:

Article no: STD-917686

Edition: 2

Approved: 8/11/2014

No of pages: 57

Replaces: ISO 14708-1:2000