GB/T 19634-2021 (English Version) PDF

Scope: This document specifies the terms and definitions, requirements, test methods, labels and instructions for use, packaging, transportation and storage of blood glucose monitoring systems for self-test. This document is applicable to self-test blood glucose monitoring systems (usually including portable blood glucose meters, disposable test strips and quality control substances) for in vitro monitoring of glucose concentration in human capillary whole blood. This document does not apply to: --- Blood glucose concentration measurement for the purpose of diagnosing diabetes; --- Measurement procedures with graded measurement values (such as visual semi-quantitative measurement procedures), non-invasive blood glucose monitoring systems, continuous blood glucose monitoring systems .

GB/T 19634-2021 Referenced Document

GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 1:General requirements
GB/T 18268.26 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 29791.4 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.5 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting

2021 GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
2005 GB/T 19634-2005 In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing