11.100.10: In vitro diagnostic test systems
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MOST RECENT
ISO 15198:2004
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
- MULTI-USER
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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
- MULTI-USER
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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ISO/TR 18112:2006 [ Withdrawn ]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
- MULTI-USER
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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
- MULTI-USER
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MOST RECENT
ISO 20916:2019
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
standard by International Organization for Standardization, 05/01/2019.
Languages: English
- MULTI-USER
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MOST RECENT
ISO 23640:2011
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
standard by International Organization for Standardization, 12/01/2011.
Languages: English
- MULTI-USER
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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
- MULTI-USER
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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
- MULTI-USER
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MOST RECENT
ISO 18113-2:2022
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
standard by International Organization for Standardization, 09/30/2022.
Languages: English
Historical Editions: ISO 18113-2:2009
- MULTI-USER
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HISTORICAL
ISO 18113-2:2009
This document has been replaced. View the most recent version.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
standard by International Organization for Standardization, 12/15/2009.
Languages: English
Historical Editions: ISO 18113-2:2022
- MULTI-USER
