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BS PD ISO/TR 15499 : 2016

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BS PD ISO/TR 15499 : 2016

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS

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 Biological evaluation as a risk management<br>&nbsp;&nbsp;practice<br>5 Guidance on risk management<br>6 Guidance on specific aspects of biological<br>&nbsp;&nbsp;evaluation<br>Bibliography

Abstract

Pertains to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

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