DZ/T 0101.12-1994
Active
YY/T 1529-2024
Active
Industry standards-Medicine
YY/T 1529-2024 ELISA analytical instruments
YY/T 1529-2024 ELISA analytical instruments
Basic Information
Standard Code:
YY/T 1529-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2024-09-29
Implement Date:
2025-10-15
Pages:
20 pages
Scope
This document specifies the requirements, marking, labeling, and user manuals for enzyme-linked immunosorbent assay analyzers (hereinafter referred to as analyzers), as well as their packaging, storage, and transportation. It also describes the corresponding test methods.
This document applies to enzyme-linked immunosorbent assay (ELISA) analyzers that use the ELISA method and the Lambert-Beer law as measurement principles to conduct quantitative or qualitative analysis of target substances. These analyzers typically include detection modules, reagent addition modules, incubation modules, and cleaning modules, among others.
Development Information
Replace the following standards
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/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
JJG 861-2007 ELISA Analytical Instruments
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
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