In vitro diagnostics for clinical trials

In vitro diagnostics for clinical trials, Total:17 items.

The international standard classification for "In vitro diagnostics for clinical trials" includes: Laboratory medicine .

The Chinese standard classification for "In vitro diagnostics for clinical trials" includes: Medical laboratory equipment , Sanitation in general .

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General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

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

Professional Standard - Medicine

• YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry

中华人民共和国国家卫生和计划生育委员会

• 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

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

Korean Agency for Technology and Standards (KATS)

• 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 TR 18112-2020 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 Association of Australia （SAA）

• AS ISO 20776.1:2017 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 antimicro

Gosstandart of Russia

• 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 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

Danish Standards Foundation

• DANSK DS/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

British Standards Institution (BSI)

• 06/30146522 DC BS ISO 18113-4. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
• 06/30146515 DC BS ISO 18113-2. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use

GCC Standardization Organization

• GSO ISO 16256:2016 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

Kingdom of Bahrain Testing and Metrology Directorate

• BH GSO 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

The Directorate General of Specifications and Metrology (DGSM)

• OS GSO ISO 16256:2016 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

Association Francaise de Normalisation

• 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

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