Table of Contents

Foreword<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Intended performance<br>5 Design attributes<br>6 Design evaluation<br>7 Sterilization<br>8 Product stability<br>9 Integrity and performance of the delivery system<br>10 Packaging<br>11 Information supplied by the manufacturer<br>Annex A (normative) - Intraocular implantation test<br>Annex B (informative) - Clinical investigation<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directive 93/42/EEC

Abstract

Defines requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/172/7
Supersedes	14/30295064 DC : 0 01/561619 DC : DRAFT MAY 2001