AAMI ISO 10993-1 : 2009 : R2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
English
01-01-2013
31-12-2025
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-1:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management process
Annex C (informative) - Suggested procedure for literature review
Bibliography
Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyze the biological safety of the medical device; - the assessment of the biological safety of the medical device.
| Committee |
WG 01
|
| DocumentType |
Standard
|
| Pages |
39
|
| ProductNote |
Reconfirmed 2013
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2009 | Identical |
A newer version of this standard is available.
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