ISO 14630:2008

Non-active surgical implants — General requirements

Datum objavljivanja: 7. 1. 2008.

95.99 Povučen 28. 11. 2012.

Опште информације

Trenutna faza: 95.99 Effective date: 28. 11. 2012.

Inicijator: ISO

Pripada: ISO/TC 150

Vrsta: Međunarodni standard

ICS: 11.040.40

Jezik: engleski francuski

Kupovina

Status: Povučen

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Apstrakt

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.