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GB/T 19634-2005 (GBT 19634-2005)

Chinese standards (related to): 'GB/T 19634-2005'
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GB/T 19634-2005English125 Add to Cart 0--10 minutes. Auto immediate delivery. [Including 2006XG1] In vitro diagnostic test systems -- General technical requirement for blood-glucose monitoring systems for self-testing GB/T 19634-2005 Valid GBT 19634-2005


   
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 17,178
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
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee
Proposing organization State Food and Drug Administration
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).