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Safety of In Vitro Diagnostics

Safety of In Vitro Diagnostics, Total:26 items.

In the international standard classification, Safety of In Vitro Diagnostics involves: Quality, Medical equipment, Medical sciences and health care facilities in general, Laboratory medicine, Analytical chemistry, Lamps and related equipment.

RU-GOST R, Safety of In Vitro Diagnostics

• GOST R 56894-2016 Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices
• GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents

Korean Agency for Technology and Standards (KATS), Safety of In Vitro Diagnostics

• KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

British Standards Institution (BSI), Safety of In Vitro Diagnostics

• 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
• BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
• BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
• BS EN 13612:2002(2003) Performance evaluation of in vitro diagnostic medical devices
• BS EN 60601-2-41:2000 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
• BS EN IEC 61010-2-101:2022+A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Safety requirements for in vitro diagnostic (IVD) medical equipment

International Organization for Standardization (ISO), Safety of In Vitro Diagnostics

• ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

Association Francaise de Normalisation, Safety of In Vitro Diagnostics

• 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
• NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
• NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
• NF C74-390:1985 Electromedical equipment. Diagnostic equipment from biopotentials other than cardiographic (ecg). Requirements for safety and operation for such equipment.

European Committee for Standardization (CEN), Safety of In Vitro Diagnostics

• EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
• EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
• EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
• CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
• EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents

AENOR, Safety of In Vitro Diagnostics

• UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.

ES-UNE, Safety of In Vitro Diagnostics

• UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.

German Institute for Standardization, Safety of In Vitro Diagnostics

• DIN EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
• DIN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
• DIN EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013

Others:   ISO 23640-2011 In vitro diagnostic medical devices -- Stability assessment of in vitro diagnostic reagents, In vitro diagnostic medical devices. Stability assessment of in vitro diagnostic reagents iso 23640-2013, ISO 23640-2011 Stability assessment of in vitro diagnostic reagents, In vitro diagnostic medical devices - Quantitative measurement of biological samples - Assignment of calibrators and control materials, ISO 23640-2013 In vitro diagnostic medical devices -- Stability assessment of in vitro diagnostic reagents, In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in diabetes management, Information from Manufacturers of In Vitro Diagnostic Medical Devices Part 4, Reference method for in vitro diagnostics, Safety of In Vitro Diagnostics, Stability of In Vitro Diagnostic Reagents, In Vitro Diagnostic Instruments, in vitro diagnostic methods, iso-23640-2011 - Stability assessment of in vitro diagnostic reagents, Reference Laboratory for In Vitro Diagnostics, ISO 23640-2015 In vitro diagnostic medical devices. Stability assessment of in vitro diagnostic reagents.