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Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2

CLSI ISO 20776-2:2021

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2

Published in 2021

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In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice

CLSI ISO 20916:2019

In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice

Published in 2019

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In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

CLSI ISO 21151:2020

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

Published in 2020

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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

CLSI ISO 21474-1:2020

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

Published in 2020

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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

CLSI ISO 21474-2:2022

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

Published in 2022

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Medical laboratories — Application of risk management to medical laboratories

CLSI ISO 22367:2020

Medical laboratories — Application of risk management to medical laboratories

Published in 2020

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

CLSI ISO 23118:2021

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

Published in 2021

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Basic semen examination — Specification and test methods

CLSI ISO 23162:2021

Basic semen examination — Specification and test methods

Published in 2021

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In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

CLSI ISO 23640:2011

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Published in 2011

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Biorisk Management for Laboratories and Other Related Organizations

CLSI ISO 35001:2019

Biorisk Management for Laboratories and Other Related Organizations

Published in 2019

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