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BS PD ISO/TR 10993-22 : 2017

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BS PD ISO/TR 10993-22 : 2017

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 22: GUIDANCE ON NANOMATERIALS

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General principles<br>5 Characterization of nanomaterials<br>6 Sample preparation<br>7 Release of nano-objects from medical devices<br>8 Toxicokinetics<br>9 Toxicological evaluation<br>10 Presentation of characterization and test results<br>11 Risk assessment<br>12 Biological evaluation report<br>Bibliography

Abstract

Gives considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/194