GB/T 19634-2021 Active
GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
Abstract
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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 19634-2021 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2023-05-01 |