BS EN 30993-1:1994
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices Guidance on selection of tests
Hardcopy , PDF
03-15-1998
English
10-15-1994
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Cooperating organizations
National foreword
Foreword
Introduction
Guide
1. Scope
2. Normative references
3. Definitions
4. General principles applying to biological evaluation
of materials and devices
5. Categorization of medical devices
6. Testing
7. Guidance on selection of biological evaluation tests
8. Assurance of test methods
Annexes
A. (informative) Rationale
B. (informative) Bibliography of international and
national standards and regulations
Tables
1. Guidance for initial evaluation tests
2. Guidance for supplementary evaluation tests
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references
Gives advice on the fundamental principles governing the biological evaluation of medical devices; and the selection of appropriate tests. Also helps with the definition of categories of devices based on the nature and duration of contact with the body. Also gives detailed definitions, tables and annexes.
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes BS 5736-1(1989). (04/2007)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2009 | Similar to |
| UNE-EN 30993-1:1994 | Identical |
| EN 30993-1 : 1994 | Identical |
| UNI EN 30993-1 : 1995 | Identical |
| NF EN 30993-1 : 1994 | Identical |
| NBN EN 30993-1 : 1995 | Identical |
| I.S. EN 30993-1:1995 | Identical |
| DIN EN 30993-1:1994-12 | Identical |
| BS EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| BS EN 30993-6:1995 | Biological evaluation of medical devices Tests for local effects after implantation |
| BS EN 30993-4:1994 | Biological evaluation of medical devices Selection of tests for interactions with blood |
| EN 30993-4 : 1993 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| BS EN ISO 3336:1996 | Dentistry. Synthetic polymer teeth |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 9001:2015 | Quality management systems — Requirements |
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