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

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194