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DIN EN ISO 14630:2009

Non-active surgical implants - General requirements (ISO 14630:2008); German version EN ISO 14630:2009 (Foreign Standard)

This Standard specifies general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.

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Deutsches Institut für Normung [din]

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