Standard Svensk standard · SS-EN ISO 15798:2013

Ögonoptik - Ögonimplantat - Viskokirurgiska hjälpmedel (ISO 15798:2013)

Status: Gällande · Tillägg: SS-EN ISO 15798:2013/A1:2017

Omfattning
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.

This International Standard specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Ämnesområden

Utrustning för ögonoptik (11.040.70)


Produktinformation

Språk: Engelska

Framtagen av: Ögonoptik, SIS/TK 336

Internationell titel: Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)

Artikelnummer: STD-99541

Utgåva: 3

Fastställd: 2013-09-27

Antal sidor: 32

Ersätter: SS-EN ISO 15798:2010