Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½± 14630:2008
Ïã¸ÛÁùºÏ²Ê¿ª½± 14630:2008
Non-active surgical implants — General requirements
Edition 3
2008-01
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½± 14630:2008
42966
Withdrawn (Edition 3, 2008)

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½± 14630:2008 specifies general requirements for non-active surgical implants. Ïã¸ÛÁùºÏ²Ê¿ª½± 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, Ïã¸ÛÁùºÏ²Ê¿ª½± 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.

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