YY/T 1529-2017 Active Industry standards-Medicine

YY/T 1529-2017 ELISA analytical instruments

YY/T 1529-2017 ELISA analytical instruments

Publish Date: 2017-05-02 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1529-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2017-05-02

Implement Date: 2018-04-01

Pages: 10 pages

Scope

This standard defines the terms and definitions of enzyme-linked immunosorbent assay analyzers (hereinafter referred to as analyzers), and stipulates their classification, requirements, test methods, marking, labeling, user manuals, packaging, storage, and transportation.
This standard applies to enzyme-linked immunosorbent assay analyzers and the reading modules of fully automatic enzyme-linked immunosorbent assay analyzers.

Development Information

Word Count: 18 Thousand words Pages: 10 pages

Superseded by the following standards

YY/T 1529-2024 ELISA analytical instruments

Referenced Standards

JJG 861-2007 ELISA Analytical Instruments 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/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

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