YY/T 0456.1-2003
Replaced
YY/T 1155-2019
Active
Industry standards-Medicine
YY/T 1155-2019 Automatic luminescence immunoassay analyzer
YY/T 1155-2019 Automatic luminescence immunoassay analyzer
Price:
$ 32.00
Basic Information
Standard Code:
YY/T 1155-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2019-05-31
Implement Date:
2020-06-01
Pages:
11 pages
Scope
This standard specifies the requirements, test methods, labels, markings, and user manuals, packaging, transportation, and storage for fully automatic luminescence immunoassay analyzers.
This standard applies to fully automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. The analyzers use luminescence systems and immunoassay methods to quantitatively or qualitatively detect various analytes in human serum, plasma, or other body fluids, including luminescence immunoassay analyzers based on principles such as chemiluminescence, electrochemiluminescence, and fluorescence.
This standard does not apply to:
- luminescence immunoassay analyzers based on image recognition;
- fully automatic luminescence immunoassay analyzers for point-of-care testing (POCT).
Development Information
Replace the following standards
YY/T 1155-2009
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 4793.6-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for laboratory equipment for the heating of materials
GB 4793.6-2008 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 6:Particular requirements for laboratory equipment for the heating of materials
GB 4793.9-2013 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
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
GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment
GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
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 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
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