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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
British Standards Institution
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Availability date: 11/05/2021
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Biological evaluation as a risk management<br> practice<br>5 Guidance on risk management<br>6 Guidance on specific aspects of biological<br> evaluation<br>Bibliography
Pertains to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/194 |