ISO 14630:2012
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ISO 14630:2012
61749

Abstract

 Preview

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 

  •  : Published
     : 2012-12
  •  : 4
     : 13
  •  : ISO/TC 150 Implants for surgery
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

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