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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.
| Author | ISO/TC 150 Implants for surgery |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 4 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics
|
| Number of pages | 13 |
| Replace | ISO 14630:2008 |
| Weight(kg.) | 0.1221 |
| Year | 2012 |
| Country | Switzerland |