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  • PD CEN/TS 16945:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-06-2021

    Language(s):  English

    Published date:  31-05-2016

    Publisher:  British Standards Institution

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

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General Considerations
    5 Urine
    6 Blood
    Annex A (informative) - Long-term stability of
            urine and serum [1]H NMR metabolic profiles
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis.

    Scope - (Show below) - (Hide below)

    This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.

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

    Committee CH/212
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/TS 80004-6:2013 Nanotechnologies Vocabulary Part 6: Nano-object characterization
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO Guide 30:2015 Reference materials Selected terms and definitions
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