TC 212: Clinical laboratory testing and in vitro diagnostic test systems

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  1. HISTORICAL

    ISO 17511:2003▹

    This document has been replaced. View the most recent version.

    In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials

    standard by International Organization for Standardization, 08/15/2003.

    Languages: English

    Historical Editions: ISO 17511:2020

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  2. MOST RECENT

    ISO 17511:2020▹

    In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

    standard by International Organization for Standardization, 04/01/2020.

    Languages: English

    Historical Editions: ISO 17511:2003

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  3. MOST RECENT

    ISO/TS 17518:2015▹

    Medical laboratories - Reagents for staining biological material - Guidance for users

    standard by International Organization for Standardization (Technical Standard), 04/15/2015.

    Languages: English

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  4. HISTORICAL

    ISO 17593:2007▹

    This document has been replaced. View the most recent version.

    Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

    standard by International Organization for Standardization, 04/15/2007.

    Languages: English

    Historical Editions: ISO 17593:2022

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  5. MOST RECENT

    ISO 17593:2022▹

    Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

    standard by International Organization for Standardization, 03/01/2022.

    Languages: English

    Historical Editions: ISO 17593:2007

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  6. HISTORICAL

    ISO/TS 17822-1:2014▹ [ Withdrawn ]

    This document has been replaced. View the most recent version.

    In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions

    standard by International Organization for Standardization (Technical Standard), 12/15/2014.

    Languages: English

    Historical Editions: ISO 17822:2020

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  7. MOST RECENT

    ISO 17822:2020▹

    In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guideLaboratory quality practice guide

    standard by International Organization for Standardization, 12/01/2020.

    Languages: English

    Historical Editions: ISO/TS 17822-1:2014

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  8. MOST RECENT

    ISO/TR 18112:2006▹ [ Withdrawn ]

    Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer

    standard by International Organization for Standardization (Technical Report), 01/15/2006.

    Languages: English

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  9. HISTORICAL

    ISO 18113-1:2009▹

    This document has been replaced. View the most recent version.

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

    standard by International Organization for Standardization, 12/15/2009.

    Languages: English

    Historical Editions: ISO 18113-1:2022

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  10. MOST RECENT

    ISO 18113-1:2022▹

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements

    standard by International Organization for Standardization, 09/30/2022.

    Languages: English

    Historical Editions: ISO 18113-1:2009

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