I.S. EN 30993-4:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
17-01-2003
English
01-01-1994
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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 to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| SN EN 30993-4 : 1994 | Identical |
| BS EN 30993-4:1994 | Identical |
| EN 30993-4 : 1993 | Identical |
| NBN EN 30993-4 : 1994 | Identical |
| ISO 10993-4:2017 | Identical |
| UNI EN 30993-4 : 1995 | Identical |
| UNE-EN 30993-4:1994 | Identical |
| NF EN 30993-4 : 1994 | Identical |
| DIN EN 30993-4:1994-06 | Identical |
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