NBN EN ISO 10993-4 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood
(as categorised in ISO 10993-1)
5.1 Non-contact devices
5.2 External communicating devices
5.3 Implant devices
6 Characterization of blood interactions
6.1 General requirements
6.2 Categories of tests and blood interactions
6.3 Types of test
Annex A (informative) Preclinical evaluation of
cardiovascular devices and prostheses
Annex B (informative) Laboratory tests - Principles,
scientific basis and interpretation
Annex C (informative) Evaluation of haemolytic properties
of medical devices and their components
Bibliography
Gives general requirements for evaluating the interactions of medical devices with blood.
| DevelopmentNote |
Supersedes NBN EN 30993-4. (06/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 10993-4:2017 | Identical |
| UNI EN ISO 10993-4 : 2009 | Identical |
| NF EN ISO 10993-4 : 2017 | Identical |
| EN ISO 10993-4:2017 | Identical |
| SN EN ISO 10993-4:2018 | Identical |
| ONORM EN ISO 10993-4 : 2018 | Identical |
| UNE-EN ISO 10993-4:2018 | Identical |
| I.S. EN ISO 10993-4:2017 | Identical |
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