Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 Intended performance<br>6 Design attributes<br>7 Materials<br>8 Design evaluation<br>9 Preclinical in vivo evaluation test methods for<br>&nbsp;&nbsp;&nbsp;vascular prostheses<br>10 Clinical investigation methods for vascular prostheses<br>11 Manufacturing<br>12 Sterility<br>13 Packaging and labelling<br>Annex A (informative) - Test methods<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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[OJ L 169] on medical devices

Abstract

Defines requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/150/2
Supersedes	14/30281557 DC : 0 BS ISO 7198 : 1998