ISO 14630:2005

Non-active surgical implants -- General requirements

ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.

With regard to safety, ISO 14630:2005 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.


General information

  • Status :  Withdrawn
    Publication date : 2005-05
  • Edition : 2
  • :
    ISO/TC 150
    Implants for surgery
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

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