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I.S. EN 30993-1:1995

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: GUIDANCE ON SELECTION OF TESTS

Withdrawn date

15-05-1998

Published date

10-11-1995

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
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

Provides guidance on the fundamental principles governing the biological evaluation of medical devices; the definition of categories of devices based on the nature and duration of contact with the body; the selection of appropriate tests.

DocumentType
Standard
PublisherName
National Standards Authority of Ireland
Status
Withdrawn

Standards Relationship
UNE-EN 30993-1:1994 Identical
BS 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
DIN EN 30993-1:1994-12 Identical

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