• BS EN ISO 10993-8:2001

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Selection and qualification of reference materials for biological tests

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  31-10-2007

    Language(s):  English

    Published date:  15-08-2001

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Terms and definitions
       3.1 Certified reference material
       3.2 Reference material
       3.3 Homogeneous
       3.4 Reference method
       3.5 Stability of property values
    4 Use of certified reference materials or reference
       materials
    5 Characteristics of reference materials
       5.1 One or more property values
       5.2 Long-term availability of the reference material
       5.3 Certification of reference materials for
           biological safety testing
    6 Use of reference materials as experimental controls
       6.1 Material screening versus biocompatibility of
           medical devices
       6.2 Misuse of CRMs
    Bibliography
    Annex ZA (normative) Normative references to international
             publications with their relevant European
             publications

    Abstract - (Show below) - (Hide below)

    Gives requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It gives the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference manuals as experimental controls.

    General Product Information - (Show below) - (Hide below)

    Committee CH/194
    Development Note Supersedes 99/561061 DC. (06/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO Guide 30:2015 Reference materials Selected terms and definitions
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