This standard specifies the design principles of in vitro diagnostic medical devices for self-testing (hereinafter referred to as self-testing), marking and information provided by the manufacturer, performance evaluation, user verification, etc. This standard applies to in vitro diagnostic medical devices for self-testing. This standard does not apply to the medical characteristics of in vitro diagnostic medical devices for self-testing.
YY/T 1454-2016 Referenced Document
GB 4793.1-2007 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB/T 18268.1 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 1:General requirements
GB/T 18268.26 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment
GB/T 29791.1-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
GB/T 29791.4 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.5 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting
YY/T 1441 General requirements of performance evaluation of in vitro diagnostic medical devices
YY/T 1454-2016 history
2016YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing