In vitro diagnostic clinical evaluation
In vitro diagnostic clinical evaluation, Total:47 items.
The international standard classification for "In vitro diagnostic clinical evaluation" includes: Laboratory medicine .
The Chinese standard classification for "In vitro diagnostic clinical evaluation" includes: Medical laboratory equipment , Sanitation in general .
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
国家药品监督管理局
- YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents
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
Group Standards of the People's Republic of China
- T/CI 310-2024 Performance evaluation of blockers in raw materials for in vitro diagnostic products
- T/GDAQI 84-2022 Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents
- T/CSBME 070-2023 Clinical Image Quality Evaluation of Computed Tomography
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
Fujian Provincial Standard of the People's Republic of China
- DB35/T 1033-2010 Protocol for clinical diagnosis of fish cucurbit disease
Spanish Association for Standardization (UNE)
- UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- 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 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
British Standards Institution (BSI)
- BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
Association Francaise de Normalisation
- NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
- NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
SCC
- DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- AENOR UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
- DIN EN ISO 23640 E:2013 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
- AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
- AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
German Institute for Standardization
- 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 6809-3:1990 Clinical dosimetry; diagnostic radiology
Korean Agency for Technology and Standards (KATS)
- 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 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
- 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
- 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
European Committee for Standardization (CEN)
- EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
- EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
GOSTR
- GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
American Society for Testing and Materials (ASTM)
- ASTM F2884-12 Standard Guide for Pre-clinical
in vivo Evaluation of Spinal Fusion
KR-KS
- KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
International Organization for Standardization (ISO)
- ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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