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.
Document identifier
ISO 14630:2012
Title
Non-active surgical implants - General requirements
ISO Category
TC 150: Implants for surgery
Publication date
2012-12-01
International Relationship
BS EN ISO 14630:2012 * DIN EN ISO 14630 * BS EN ISO 14630:2012
History of version
ISO 14630:2012 * ISO 14630:2008 * ISO 14630:2005
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