YY/T 1261-2015 Active Industry standards-Medicine

YY/T 1261-2015 Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization )

YY/T 1261-2015 Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization )

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1261-2015

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 7 pages

Scope

This standard specifies the definition, requirements, test methods, marking, labeling, user's manual, packaging, transportation, and storage of HER2 gene detection kits (fluorescence in situ hybridization method).
This standard applies to kits composed of HER2 gene loci and fluorescence in situ hybridization probes and counterstaining agents on chromosome 17. By detecting abnormalities in the HER2 gene loci on samples (usually breast cancer tissue sections), the kits assist in diagnosing tumors related to the HER2 gene (such as breast cancer) and guide clinical medication during treatment.

Development Information

Word Count: 12 Thousand words Pages: 7 pages

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 0456.1-2003 Replaced

YY/T 0456.1-2003 Regents for hematology analyzer use—Part 1:Rinse

Publish Date: 2003-06-20

YY/T 0456.2-2003 Replaced

YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin

Publish Date: 2003-06-20

YY/T 0456.3-2003 Replaced

YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent

Publish Date: 2003-06-20

YY/T 0475-2004 Replaced

YY/T 0475-2004 General technical requirements for urine analyzer

Publish Date: 2004-03-23

YY/T 0478-2004 Replaced

YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis

Publish Date: 2004-03-23

YY/T 0032-2004 Active

YY/T 0032-2004 Haemoglobin instrument

Publish Date: 2004-11-08