Standard Svensk standard · SS-EN ISO 21534:2009

Icke aktiva kirurgiska implantat - Ledimplantat - Särskilda krav (ISO 21534:2007)

Status: Gällande

Omfattning
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".

It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.

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 - Joint replacement implants - Particular requirements (ISO 21534:2007)

Artikelnummer: STD-69800

Utgåva: 2

Fastställd: 2009-05-25

Antal sidor: 32

Ersätter: SS-EN ISO 21534:2007