YY/T 0456.1-2003
Replaced
YY/T 1454-2016
Active
Industry standards-Medicine
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
Basic Information
Standard Code:
YY/T 1454-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
7 pages
Scope
This standard specifies the design principles, markings and information provided by manufacturers, performance evaluation, and user verification for in vitro diagnostic medical devices used for self-testing (hereinafter referred to as self-testing).
This standard applies to in vitro diagnostic medical devices used for self-testing.
This standard does not apply to the medical characteristics of in vitro diagnostic medical devices used for self-testing.
Development Information
Referenced Standards
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements
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 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
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
GB/T 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.5-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 5:In vitro diagnostic instruments for selftesting
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active