M00029490
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Biological evaluation as a risk management
practice
5 Guidance on risk management
6 Guidance on specific aspects of biological
evaluation
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 | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 194 |