This standard has been revised by: ISO 14630:2012
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 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 14630:2008 gives 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. Additional tests are given or referred to in level 2 and level 3 standards.
Document published on: 2008-01 Edition: 3 (Monolingual) ICS: 11.040.40 Status: Withdrawn Stage: 95.99 (2012-11-28) TC/SC: ISO/TC 150 Number of Pages:
Revised by: ISO 14630:2012
Revises: ISO 14630:2005
No corrigenda or amendments available