YY/T 1652-2019 Active Industry standards-Medicine

YY/T 1652-2019 General technical requirements of quality control materials for in vitro diagnostic reagents

YY/T 1652-2019 General technical requirements of quality control materials for in vitro diagnostic reagents

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1652-2019

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 for quality control materials used in in vitro diagnostic reagents, test methods, labels and user manuals, packaging, transportation, and storage.
This standard applies to quality control materials intended for use in the quality control of adaptive reagents.

Development Information

Word Count: 20 Thousand words Pages: 11 pages

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 JJF 1005-2016 General Terms and Definitions Used in Connection with Reference Materials 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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