ISO 14630:2005

Non-active surgical implants — General requirements

Publication date:   May 4, 2005

95.99 Withdrawal of Standard   Jan 7, 2008

General information

95.99 Withdrawal of Standard   Jan 7, 2008

ISO

ISO/TC 150 Implants for surgery

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

ISO 14630:2005 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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14630:1997

NOW

WITHDRAWN
ISO 14630:2005
95.99 Withdrawal of Standard
Jan 7, 2008

REVISED BY

WITHDRAWN
ISO 14630:2008