Standard

NS-EN ISO 14630:2012

Mar 2013 Withdrawn

Note: This standard has a new edition: NS-EN ISO 14630:2024

Corrigendums and amendments are bought separately.

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Abstract

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.

Document information

Standard from SN
Published: 1 March 2013
Withdrawn: 9 January 2025
Edition: 2012-12
Version: 1
Document type: NAT
ISBN:

ICS 11.040.40
National Committee CEN/TC 285

Legal references

EU law: 93/42/EEC, 2007/47/EC

Product Relations

Replaced by: NS-EN ISO 14630:2024
Refers: NS-ISO 80000-7:2008
Replaces: NS-EN ISO 14630:2009
Refers: NS-ISO 8601:2004
Adopted from: EN ISO 14630:2012 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 14630:2009
Current product

Withdrawn

NS-EN ISO 14630:2012
Replaced by

Draft

prNS-EN ISO 14630:2022

Published

NS-EN ISO 14630:2024

NS-EN ISO 14630:2012

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NS-EN ISO 14630:2024