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In vitro diagnostic clinical evaluation

In vitro diagnostic clinical evaluation, Total:80 items.

In the international standard classification, In vitro diagnostic clinical evaluation involves: Laboratory medicine, Medical sciences and health care facilities in general, Medical equipment.

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, In vitro diagnostic clinical evaluation

GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

Professional Standard - Medicine, In vitro diagnostic clinical evaluation

YY/T 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
YY/T 0688.2-2010 Clinical laboratory testing and in vitro diagnostic test systems.Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices.Part 2 : Evaluation of performance of antimicrobial susceptibility test devi
YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic test systems -Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices -Part 1: Reference method for testing the in vitro activity of antimicrobia

ES-UNE, In vitro diagnostic clinical evaluation

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN 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 (ISO 16256:2021) (Endorsed by Asociac...

Association Francaise de Normalisation, In vitro diagnostic clinical evaluation

NF EN ISO 23640:2015 Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
NF EN 13612:2002 Évaluation des performances des dispositifs médicaux de diagnostic in vitro
NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
NF S92-053-2*NF EN ISO 20776-2:2022 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 : evaluation of performance of antimicrobial susceptibility
NF S92-012*NF EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
NF S92-012*NF EN 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

German Institute for Standardization, In vitro diagnostic clinical evaluation

DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
DIN EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
DIN EN ISO 16256:2022-02 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 (ISO 16256:2021); German version EN I...
DIN EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012); German version EN ISO 16256:2012

国家药品监督管理局, In vitro diagnostic clinical evaluation

YY/T 1579-2018 In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation

Korean Agency for Technology and Standards (KATS), In vitro diagnostic clinical evaluation

KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P 1800-2013 Protocol for evaluation of matrix effects in in-vitro diagnostic test
KS P ISO TR 18112-2009(2014) 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 manufacture
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 ISO 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
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 16256:2017 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

AENOR, In vitro diagnostic clinical evaluation

UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 20776-2:2008 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: Evaluation of performance of antimicrobial susceptibility t
UNE-EN ISO 20776-1:2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim
UNE-EN ISO 16256:2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)

European Committee for Standardization (CEN), In vitro diagnostic clinical evaluation

EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
prEN 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 - Part 2: Evaluation of performance of antimicrobial susceptibility test devi
EN 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 (ISO 16256:2021)
EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)

British Standards Institution (BSI), In vitro diagnostic clinical evaluation

BS EN ISO 23640:2015 Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
21/30425530 DC BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test. Part 2. Evaluation of performance of antimicrobial susc...
BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
BS EN ISO 20776-2:2021 Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial suscep...
BS EN ISO 16256:2012 Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
BS ISO 21474-1:2020 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
BS EN ISO 16256:2021 Tracked Changes. 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
BS EN ISO 20776-2:2007 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test device

GOSTR, In vitro diagnostic clinical evaluation

GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R ISO 20776-2-2010 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. Evaluation of performance of antimicrobial susceptibility tes
GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer
GOST R ISO 20776-1-2010 Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 1. Reference method for testing the in vitro activity of antimic

中华人民共和国国家卫生和计划生育委员会, In vitro diagnostic clinical evaluation

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline

Shanxi Provincial Standard of the People's Republic of China, In vitro diagnostic clinical evaluation

DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

American Society for Testing and Materials (ASTM), In vitro diagnostic clinical evaluation

ASTM F2884-12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

Group Standards of the People's Republic of China, In vitro diagnostic clinical evaluation

T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents

KR-KS, In vitro diagnostic clinical evaluation

KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
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
KS P ISO 16256-2017 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
KS P ISO 16256-2022 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 infec

国家药监局, In vitro diagnostic clinical evaluation

YY/T 1789.1-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 1: Precision
YY/T 1789.2-2021 Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy
YY/T 1789.5-2023 Methods for performance evaluation of in vitro diagnostic test systems Part 5: Analytical specificity
YY/T 1789.6-2023 In vitro diagnostic testing system performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
YY/T 1789.3-2022 In vitro diagnostic testing system performance evaluation methods Part 3: Detection limit and quantitation limit
YY/T 1728-2021 Reference method for in vitro activity testing of yeast-like fungal antimicrobials related to systemic infectious diseases for clinical laboratory testing and in vitro diagnostics
YY/T 1789.4-2022 In vitro diagnostic testing system performance evaluation methods Part 4: Linear intervals and reportable intervals

AT-ON, In vitro diagnostic clinical evaluation

OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

International Organization for Standardization (ISO), In vitro diagnostic clinical evaluation

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ISO 16256:2012 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
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

RU-GOST R, In vitro diagnostic clinical evaluation

GOST R ISO 16256-2015 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
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement

Indonesia Standards, In vitro diagnostic clinical evaluation

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

IT-UNI, In vitro diagnostic clinical evaluation

UNI ISO 21474-1:2021 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation