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In Vitro Diagnostic Clinical Trials

In Vitro Diagnostic Clinical Trials, Total:85 items.

In the international standard classification, In Vitro Diagnostic Clinical Trials involves: Laboratory medicine, Medical sciences and health care facilities in general, Medical equipment, Packaging and distribution of goods in general.

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, In Vitro Diagnostic Clinical Trials

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

RU-GOST R, In Vitro Diagnostic Clinical Trials

GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications
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 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories
GOST R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

Professional Standard - Medicine, In Vitro Diagnostic Clinical Trials

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

中华人民共和国国家卫生和计划生育委员会, In Vitro Diagnostic Clinical Trials

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

Korean Agency for Technology and Standards (KATS), In Vitro Diagnostic Clinical Trials

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 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 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
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 TR 18112:2009 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
KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
KS P ISO 20776-2:2009 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 test d

Shanxi Provincial Standard of the People's Republic of China, In Vitro Diagnostic Clinical Trials

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

Association Francaise de Normalisation, In Vitro Diagnostic Clinical Trials

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 S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
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 S92-012*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
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 S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
NF S92-053-2*NF 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 - Part 2 : evaluation of performance of antimicrobial susceptibility

European Committee for Standardization (CEN), In Vitro Diagnostic Clinical Trials

EN 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
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)
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 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 t
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN ISO 20776-1:2020 Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi

GOSTR, In Vitro Diagnostic Clinical Trials

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
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

International Organization for Standardization (ISO), In Vitro Diagnostic Clinical Trials

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
ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO/TR 18112:2006 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
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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 - Part 2: Evaluation of performance of antimicrobial susceptibility t
ISO 20776-1:2019 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: Refe

KR-KS, In Vitro Diagnostic Clinical Trials

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 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
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
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

British Standards Institution (BSI), In Vitro Diagnostic Clinical Trials

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 EN 13640:2002 Stability testing of in vitro diagnostic reagents
BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
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 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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
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...
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 EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

AENOR, In Vitro Diagnostic Clinical Trials

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)
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 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

Indonesia Standards, In Vitro Diagnostic Clinical Trials

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

AT-ON, In Vitro Diagnostic Clinical Trials

OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
OENORM 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/DIS 16256:2021)
ONORM EN 829-1996 In vitro diagnostic systems-Transport packages for medical and biological specimens-Requirements,test

German Institute for Standardization, In Vitro Diagnostic Clinical Trials

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 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
DIN 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/DIS 16256:2021); German and English
DIN 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

Professional Standard - Agriculture, In Vitro Diagnostic Clinical Trials

164药典三部-2015 Monograph IV In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents
138药典三部-2010 Items of each monograph Ⅳ In vitro diagnosis of syphilis Toluidine red unheated serum test diagnostic reagents

ES-UNE, In Vitro Diagnostic Clinical Trials

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...

国家药监局, In Vitro Diagnostic Clinical Trials

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

CEN - European Committee for Standardization, In Vitro Diagnostic Clinical Trials

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 - Part 2: Evaluation of performance of antimicrobial susceptibility t
EN ISO 20776-1:2006 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