UNI EN 30993-4 : 1995
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
01-06-2004
12-01-2013
Cooperating organizations
National foreword
Foreword
Guide
Introduction
1. Scope
2. Normative references
3. Definitions
4. Abbreviations
5. Devices contacting blood
6. Tests
Annexes
A. (informative) Evaluation of cardiovascular devices
and prostheses during in vivo function
B. (informative) Laboratory tests: principles and
scientific basis
C. (informative) Bibliography
Tables
1. Abbreviations
2. External communicating devices - Level 1 - Blood
path, indirect
3. External communicating devices - Level 1 -
Circulating blood
4. External communicating devices - Level 2 - Optional
5. Implant devices - Level 1
6. Implant devices - Level 2 - Optional
7. Commercially available assays for platelet,
coagulation, fibrinolytic and complement factors
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references
Gives guidance for evaluating the interactions of medical devices with blood. Coverage includes definitions, abbreviations and devices contacting blood. Also gives detailed tables and annexes.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 30993-4 : 1993 | Identical |
| UNE-EN 30993-4:1994 | Identical |
| I.S. EN 30993-4:1994 | Identical |
| BS EN 30993-4:1994 | Identical |
| DIN EN 30993-4:1994-06 | Identical |
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