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Clinical in vitro diagnostic equipment

Clinical in vitro diagnostic equipment, Total:22 items.

In the international standard classification, Clinical in vitro diagnostic equipment involves: Laboratory medicine, Medical equipment, Applications of information technology.

Korean Agency for Technology and Standards (KATS), Clinical in vitro diagnostic equipment

• 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 18112-2009(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

International Organization for Standardization (ISO), Clinical in vitro diagnostic equipment

• 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/IEEE 11073-10408:2010 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
• ISO/IEEE 11073-10415:2010 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
• ISO/IEEE 11073-10417:2010 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter

British Standards Institution (BSI), Clinical in vitro diagnostic equipment

• BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
• BS EN ISO 23640:2015 Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
• BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

KR-KS, Clinical in vitro diagnostic equipment

• 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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Clinical in vitro diagnostic equipment

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

Professional Standard - Medicine, Clinical in vitro diagnostic equipment

• 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, Clinical in vitro diagnostic equipment

• 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, Clinical in vitro diagnostic equipment

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

Association Francaise de Normalisation, Clinical in vitro diagnostic equipment

• NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
• NF S97-518-10415*NF EN ISO 11073-10415:2011 Health informatics - Personal health device communication - Part 10415 : device specialization - Weighing scale.
• NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude

未注明发布机构, Clinical in vitro diagnostic equipment

• DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use

GOSTR, Clinical in vitro diagnostic equipment

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

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