AAMI/ISO TIR15499:2017
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
English
27-08-2017
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO/TR 15499:2016
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.
| Committee |
TC 194
|
| DocumentType |
Technical Report
|
| ISBN |
978-1-57020-686-3
|
| Pages |
26
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/TR 15499:2016 | Identical |
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