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

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  1. MOST RECENT

    ISO 15194:2009▹

    In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation

    standard by International Organization for Standardization, 05/01/2009.

    Languages: English

    Historical Editions: ISO 15194:2002

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  2. HISTORICAL

    ISO 15195:2003▹

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

    Laboratory medicine - Requirements for reference measurement laboratories

    standard by International Organization for Standardization, 10/01/2003.

    Languages: English

    Historical Editions: ISO 15195:2018

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  3. MOST RECENT

    ISO 15195:2018▹

    Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures

    standard by International Organization for Standardization, 01/01/2018.

    Languages: English

    Historical Editions: ISO 15195:2003

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  4. HISTORICAL

    ISO 15197:2003▹

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

    In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

    standard by International Organization for Standardization, 05/01/2003.

    Languages: English

    Historical Editions: ISO 15197:2013

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  5. MOST RECENT

    ISO 15197:2013▹

    In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

    standard by International Organization for Standardization, 05/15/2013.

    Languages: English

    Historical Editions: ISO 15197:2003

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  6. MOST RECENT

    ISO 15198:2004▹ [ Withdrawn ]

    Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

    standard by International Organization for Standardization, 07/15/2004.

    Languages: English

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  7. HISTORICAL

    ISO 16256:2012▹

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

    Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

    standard by International Organization for Standardization, 12/01/2012.

    Languages: English

    Historical Editions: ISO 16256:2021

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  8. MOST RECENT

    ISO 16256:2021▹

    Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

    standard by International Organization for Standardization, 10/01/2021.

    Languages: English

    Historical Editions: ISO 16256:2012

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  9. MOST RECENT

    ISO/TS 16766:2024▹

    Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

    standard by International Organization for Standardization (Technical Standard), 11/01/2024.

    Languages: English

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  10. MOST RECENT

    ISO/TS 16782:2016▹

    Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

    standard by International Organization for Standardization (Technical Standard), 10/15/2016.

    Languages: English

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