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ISO 14630:2012

Non-active surgical implants — General requirements

Standard Details

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
Standard Type: Main
Document No: ISO 14630:2012
Document Year: 2012
Pages: 13
Edition: 4
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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ISO 14630:2012
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