Table of Contents

European foreword<br>Foreword<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Common provisions for implantation test methods<br>5 Test methods, general aspects<br>6 Test report<br>Annex A (normative) - Test methods for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;implantation in subcutaneous tissue<br>Annex B (normative) - Test method for implantation <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in muscle<br>Annex C (normative) - Test method for implantation <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in bone<br>Annex D (normative) - Test method for implantation <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in brain tissue<br>Annex E (informative) - Examples of evaluation of local <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;biological effects after implantation<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 Directive 93/42/EEC <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[OJ L 169] aimed to be covered <br>Annex ZB (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 Directive 90/385/EEC <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[OJ L 189] aimed to be covered

Abstract

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194
Supersedes	ISO/DIS 10993-6 : 60.00 (2016)