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medical diagnostic laboratory

medical diagnostic laboratory, Total:8 items.

In the international standard classification, medical diagnostic laboratory involves: Laboratory medicine.

Korean Agency for Technology and Standards (KATS), medical diagnostic laboratory

• KS P 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
• KS P 1977-2018 Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
• KS P 1975-2018 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
• KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
• KS P 2094-2020 Protocol for measurement procedures comparison and bias estimation using patient samples in in-vitro diagnostic medical laboratory

KR-KS, medical diagnostic laboratory

• KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
• KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
• KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

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