GB/T 19634-2005
In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing (English Version)
- Standard No.
- GB/T 19634-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2023-05
- Replace By
- GB/T 19634-2021
- GB/T 19634-2005(XG1-2006)
- Latest
- GB/T 19634-2021
- Scope
- This standard 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 standard applies 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 concentrations in human capillary whole blood and/or venous whole blood.
GB/T 19634-2005 Referenced Document
- GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General requirements
- GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
- GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
- YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
GB/T 19634-2005 history
- 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
