Abstract
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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General information
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Status: PublishedPublication date: 2012-12Stage: International Standard to be revised [90.92]
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Edition: 4Number of pages: 13
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Technical Committee :ISO/TC 150ICS :11.040.40
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Life cycle
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Previously
WithdrawnISO 14630:2008
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Now
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Will be replaced by
Under developmentISO/FDIS 14630
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