Standard Swedish standard · SS-EN ISO 15798:2013

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

Status: Valid · Amended by: SS-EN ISO 15798:2013/A1:2017

Scope
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.

Subjects

Ophthalmic equipment (11.040.70)


Product information

Language: English

Written by: SIS - Standardiseringens stöd

International title:

Article no: STD-99541

Edition: 3

Approved: 9/27/2013

No of pages: 32

Replaces: SS-EN ISO 15798:2010