YY/T 1592-2018
Active
Industry standards-Medicine
YY/T 1592-2018 ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)
YY/T 1592-2018 ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)
Basic Information
Standard Code:
YY/T 1592-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2018-02-24
Implement Date:
2019-03-01
Pages:
9 pages
Scope
This standard specifies the requirements, test methods, labels and instructions, packaging, transportation, and storage for ABO phenotyping and RhD blood group typing test cards (column agglutination method). This standard is applicable to microcolumn filling materials such as gels and glass microbeads, which use a combination of immunohaematology, particle sieving, and centrifugation techniques to conduct clinical red blood cell ABO blood group system phenotyping and detection of the normal D antigen in the Rh system. This standard is not applicable to diagnostic reagents used for ABO phenotyping and RhD blood group identification in blood source screening.
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/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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YY 0464-2003
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YY 0464-2003 Single use hemoperfutor
YY 0054-2003
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