NBN EN ISO 10993-1 : 2009 COR 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
12-01-2013
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
Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.
| DevelopmentNote |
Supersedes NBN EN 30993-1 (11/2003)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| 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 |
| ONORM EN ISO 10993-1 : 2011 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
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