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  • BS EN 30993-1:1994

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    Biological evaluation of medical devices Guidance on selection of tests

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  15-03-1998

    Language(s):  English

    Published date:  15-10-1994

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

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    Committee CH/194
    Development Note Supersedes BS 5736-1(1989). (04/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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