Standard Svensk standard · SS-EN ISO 14630:2012

Icke aktiva kirurgiska implantat - Allmänna krav (ISO 14630:2012)

Status: Gällande

Omfattning
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.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40)


Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

Internationell titel: Non-active surgical implants - General requirements (ISO 14630:2012)

Artikelnummer: STD-88315

Utgåva: 5

Fastställd: 2012-12-11

Antal sidor: 28

Ersätter: SS-EN ISO 14630:2009