In vitro diagnostic equipment
In vitro diagnostic equipment, Total:17 items.
The international standard classification for "In vitro diagnostic equipment" includes: Industrial process measurement and control .
The Chinese standard classification for "In vitro diagnostic equipment" includes: Medical laboratory equipment , Industrial automation and control device in general .
未注明发布机构
- CLSI EP22-P-2010 Guidance for manufacturers to present risk mitigation information to users of in vitro diagnostic devices
Group Standards of the People's Republic of China
- T/CAMDI 125-2024 Reliability test methods for in vitro diagnostic (IVD) medical equipment
Professional Standard - Medicine
- YY 0648-2008 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment
Bureau of Indian Standards
- IS 17713-2023 In-Vitro Diagnostic IVD Devices - Elisa Plate Reader
- IS 17715-2023 In-Vitro Diagnostic IVD Device - Elisa Plate Washer
- IS 17721-2024 In-Vitro Diagnostic (IVD) Devices-Electrolyte Analyzer
- IS 17714-2023 In-Vitro Diagnostic IVD Devices - Automated Elisa Processor
GOST
- GOST R ISO 18113-5-2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
- GOST R ISO 18113-3-2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
IX-EU/EC
- COM(95)/C 172/02-1995 Proposal for a European Parliament and Council Directive on in Vitro Diagnostic Medical Devices
- COM(96) 643 FINAL-1996 Amended Proposal for a European Parliament and Council Directive Amending the Directive Proposal on 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
International Organization for Standardization (ISO)
- ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
Ente Nazionale Italiano di Unificazione
- UNI EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
German Institute for Standardization
- DIN EN 592:2002 Instructions for use for devices for in-vitro diagnostic examinations for personal use
Swedish Institute for Standards
- SS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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