• BS EN ISO 19001:2013

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-08-2013

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements for information supplied by the
      manufacturer
    Annex A (informative) - Examples of information
            supplied by the manufacturer with reagents
            commonly used in biological staining
            procedures
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for information supplied by the manufacturer with reagents used in staining in biology.

    Scope - (Show below) - (Hide below)

    This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

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

    Committee CH/212
    Development Note Supersedes 10/30228700 DC. (04/2013) Supersedes BS EN 12376. (09/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 80000-1:2009 Quantities and units — Part 1: General
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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