ISO-14630 › Historical Revision Information
Non-active surgical implants -- General requirements

ISO-14630 - 1ST EDITION - SUPERSEDED
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ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.

With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

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To find similar documents by classification:

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

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Document Number

ISO 14630:1997

Revision Level

1ST EDITION

Status

Superseded

Publication Date

Nov. 1, 1997

Committee Number

ISO/TC 150