BAS EN ISO 14630:2010
Non-active surgical implants - General requirements
General Information
Status: Withdrawn
No. of pages: 19
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 14630:2009, identical
- ISO 14630:2008, identical