Standard Svensk standard · SS-EN ISO 16672:2015

Ögonimplantat - Tamponader för intraokulärt bruk (ISO 16672:2015)

Status: Gällande

Omfattning
This International Standard applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.

With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Ämnesområden

Utrustning för ögonoptik (11.040.70)


Produktinformation

Språk: Engelska

Framtagen av: Ögonoptik, SIS/TK 336

Internationell titel: Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

Artikelnummer: STD-8016021

Utgåva: 2

Fastställd: 2015-09-14

Antal sidor: 28

Ersätter: SS-EN ISO 16672