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BS EN 30993-1:1994

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices Guidance on selection of tests
Available format(s)

Hardcopy , PDF

Withdrawn date

03-15-1998

Language(s)

English

Published date

10-15-1994

Publisher

British Standards Institution

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Withdrawn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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Hardcopy - English
PDF - English
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