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ISO 14630:2012

Non-active surgical implants -- General requirements

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Kehtiv alates 28.11.2012
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28.11.2012
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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.

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ISO 10555-1:2013

Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements
Kehtetu alates 14.11.2023