YY/T 0456.1-2003
Replaced
YY/T 1246-2014
Active
Industry standards-Medicine
YY/T 1246-2014 Glycohemoglobin analyzer
YY/T 1246-2014 Glycohemoglobin analyzer
Basic Information
Standard Code:
YY/T 1246-2014
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2014-06-17
Implement Date:
2015-07-01
Pages:
7 pages
Scope
This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for glycated hemoglobin analyzers (hereinafter referred to as analyzers).
This standard applies to:
——instruments used to detect the concentration of glycated hemoglobin (HbA1c) in human blood;
——instruments that include the glycated hemoglobin (HbA1c) detection item in the testing process, when evaluating the glycated hemoglobin detection module of such instruments.
This standard does not apply to instruments used by non-professionals or outside of laboratories for detecting the concentration of glycated hemoglobin (HbA1c) in human blood.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
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
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment
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