ISO 14630:2008

Non-active surgical implants — General requirements

Publication date:   Jan 7, 2008

95.99 Withdrawal of Standard   Nov 28, 2012

General information

95.99 Withdrawal of Standard   Nov 28, 2012

ISO

ISO/TC 150 Implants for surgery

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14630:2005

NOW

WITHDRAWN
ISO 14630:2008
95.99 Withdrawal of Standard
Nov 28, 2012

CORRIGENDA / AMENDMENTS

ABANDON
ISO 14630:2008/DAmd 1

REVISED BY

WITHDRAWN
ISO 14630:2012