GB/T 19634-2021 Active National standards

GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

Publish Date: 2021-10-11 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 19634-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-10-11

Implement Date: 2023-05-01

Pages: 14 pages

Scope

This document specifies the terms and definitions, requirements, test methods, labels and user manuals, packaging, transportation, and storage for self-testing blood glucose monitoring systems.
This document applies to self-testing blood glucose monitoring systems (usually including portable blood glucose meters, disposable test strips, and quality control substances) used to monitor glucose concentrations in human capillary whole blood in vitro.
This document does not apply to:
——Determination of blood glucose concentrations for the purpose of diagnosing diabetes;
——Determination procedures with graded measurement values (such as visual semi-quantitative determination procedures), non-invasive blood glucose monitoring systems, and continuous blood glucose monitoring systems.

Development Information

Word Count: 29 Thousand words Pages: 14 pages

Replace the following standards

GB/T 19634-2005 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

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/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 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting GB/T 29791.5-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 5:In vitro diagnostic instruments for selftesting 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

Adopt standards

ISO 15197:2013

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