Clinical in vitro diagnostic equipment
Clinical in vitro diagnostic equipment, Total:18 items.
The international standard classification for "Clinical in vitro diagnostic equipment" includes: Laboratory medicine .
The Chinese standard classification for "Clinical in vitro diagnostic equipment" 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
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
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
British Standards Institution (BSI)
- BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability 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 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
- BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
International Organization for Standardization (ISO)
- 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/IEEE 11073-10408:2010 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
Korean Agency for Technology and Standards (KATS)
- 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 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
KR-KS
- 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
German Institute for Standardization
- DIN 6809-3:1990 Clinical dosimetry; diagnostic radiology
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