ISO 14630:2012 Preview

Non-active surgical implants -- General requirements

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.


General information

  • Status :  Published
    Publication date : 2012-12
  • Edition : 4
    Number of pages : 13
  • :
    ISO/TC 150
    Implants for surgery
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

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This standard contributes to the following Sustainable Development Goal:

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