• DIN EN 12287:1999-08

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-10-2009

    Language(s):  English

    Published date:  12-01-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification and naming of reference materials
    5 Description of a reference material
    6 Label
    7 Certificate
    8 Package insert
    Annex A (informative) Materials with properties other than
                          quantities
    Annex B (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
                           addressing essential requirements or
                           other provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 378. Defines requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This standard also provides instruction on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
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