NEN EN ISO 10993-1 : 2009 C1 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
01-12-2013
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General principles applying to biological evaluation
of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation tests
7 Assurance of test methods
Annex A (informative) Rationale
Annex B (informative) Flow chart to aid in ensuring a
systematic approach to biological evaluation of
medical devices
Bibliography
Explains the general principles governing the biological evaluation of medical devices within a risk management process.
| DevelopmentNote |
Supersedes NEN ISO 10993-1. (09/2002)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-1 : 2011 | Identical |
| DIN EN ISO 10993-1:2010-04 | Identical |
| NF EN ISO 10993-1 : 2010 | Identical |
| UNI EN ISO 10993-1 : 2010 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
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