Table of Contents

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (normative) - Intraocular implantation test
Annex B (informative) - Patient numbers for clinical
                        investigation of intra-ocular pressure
Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 172
Supersedes	ISO/DIS 15798 : 60.00 (2013) ISO 15798 : 2010