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.
General information
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Status : PublishedPublication date : 2012-12
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Edition : 4Number of pages : 13
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- ICS :
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Implants for surgery, prosthetics and orthotics
Buy this standard
| Format | Language | |
|---|---|---|
| PDF + ePub | ||
| Paper | ||
- CHF88
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 14630:2008
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Now under review
ISO 14630:2012 -
Will be replaced by
ISO/AWI 14630
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