GB/T 19634-2005: [Including 2006XG1] In vitro diagnostic test systems -- General technical requirement for blood-glucose monitoring systems for self-testing

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Scope

This Standard specifies the terms and definitions, requirements, test methods, labels
and instructions for use, packaging, transportation, and storage for blood-glucose
monitoring systems for self-testing.
This Standard is applicable to the blood-glucose monitoring systems for self-testing
intended for in vitro monitoring the glucose concentration in capillary whole blood
and/or venous whole blood (normally including portable glucose meters, disposable
test strips, and control materials).

Basic Data

Standard ID	GB/T 19634-2005 (GB/T19634-2005)
Description (Translated English)	[Including 2006XG1] In vitro diagnostic test systems - General technical requirement for blood-glucose monitoring systems for self-testing
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	17,131
Date of Issue	2005-01-24
Date of Implementation	2005-05-01
Quoted Standard	GB 4793.1-1995; GB 9706.1-1995; GB/T 14710-1993; YY 0466-2003
Adopted Standard	ISO 15197-2003, NEQ
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary	This standard specifies the terms and definitions for self blood glucose monitoring systems, requirements, test methods, label and instructions for use, packaging, transport and storage. This standard applies to whole blood in vitro monitoring of human blood vessels and/or venous whole blood glucose concentration of blood glucose monitoring systems for self (usually including a portable blood glucose meter, disposable test strips and quality control material).