ISO 14630:2012

Non-active surgical implants — General requirements

Datum objavljivanja: 28. 11. 2012.

95.99 Povučen 4. 9. 2024.

Опште информације

Trenutna faza: 95.99 Effective date: 4. 9. 2024.

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 14630:2012 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.