Draft
International Standard
ISO/DIS 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
Reference number
ISO/DIS 14708-1
Edition 3
© ISO 2026
Draft International Standard

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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 14708-1:2014

ISO/DIS 14708-1

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Abstract

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.

General information

  • Status
     : Under development

    You can help develop this draft international standard by contacting your national member

    Stage
    : DIS ballot initiated: 12 weeks [40.20]
  • Edition
     : 3
    Number of pages
     : 75
  • Technical Committee :
    ISO/TC 150/SC 6
    ICS :
    11.040.40 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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