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

SS-EN-ISO-15798 - 2013 EDITION - CURRENT
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Included in this current edition are the following subparts:

 2013 EDITION - Sept. 27, 2013
 2013/A1:2017 EDITION AMENDMENT - Oct. 26, 2017

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.

To find similar documents by classification:

11.040.70 (Ophthalmic equipment Including ophthalmic implants, glasses, contact lenses and their cleaning products)


Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN ISO 15798:2013

Revision Level

2013 EDITION

Status

Current

Publication Date

Sept. 27, 2013

Language(s)

English

Page Count

32

International Equivalent

EN ISO 15798:2013(IDT); ISO 15798:2013(IDT)