YY/T 0456.1-2003
Replaced
YY/T 1423-2016
Active
Industry standards-Medicine
YY/T 1423-2016 Testing kit for helicobacter pylori antibody(colloidal gold)
YY/T 1423-2016 Testing kit for helicobacter pylori antibody(colloidal gold)
Basic Information
Standard Code:
YY/T 1423-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
7 pages
Scope
This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for Helicobacter pylori antibody detection kits (colloidal gold method).
This standard applies to the quality control of kits that use the colloidal gold method to qualitatively detect Helicobacter pylori antibodies in human serum or plasma (hereinafter referred to as "Helicobacter pylori antibody detection kits").
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
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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