YY/T 0456.1-2003
Replaced
YY/T 1549-2017
Replaced
Industry standards-Medicine
YY/T 1549-2017 Calibrator for Biochemical Analyzer
YY/T 1549-2017 Calibrator for Biochemical Analyzer
Basic Information
Standard Code:
YY/T 1549-2017
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2017-05-02
Implement Date:
2018-04-01
Pages:
20 pages
Scope
This standard specifies the terms and definitions, requirements, test methods, labels and usage instructions, packaging, transportation, and storage for calibrators used in biochemical analyzers.
This standard applies to calibrators used on fully automatic and semi-automatic biochemical analyzers for clinical testing projects. Examples of clinical testing projects are provided in Appendix A.
This standard does not apply to calibrators used in electrolyte modules of biochemical analyzers.
Development Information
Superseded by the following standards
Referenced Standards
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
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 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
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