ISO 14630:2012

Non-active surgical implants — General requirements

Publication date: Nov 28, 2012

General information

Current stage: 90.92 Effective date: Sep 20, 2018

Originator: ISO

Owner: ISO/TC 150

Type: International Standard

ICS: 11.040.40

Languages: English French Russian

Buying

Status: Published

PDF - EC$276.92

Paper - EC$276.92

PDF and Paper - EC$553.84

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Scope

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 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 14630:2012 specifies 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.

Life cycle

PREVIOUSLY

Revises
ISO 14630:2008

Revises
ISO 14630:2008/DAmd 1

NOW

PUBLISHED
ISO 14630:2012
90.92 Standard to be revised
Sep 20, 2018

REVISED BY

IN_DEVELOPMENT
ISO/DIS 14630

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