GB/T 26124-2011 (English Version) PDF

Standard No.: GB/T 26124-2011
Language: Chinese, Available in English version
Release Date: 2011
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 26124-2011

Scope: This standard specifies the general technical requirements for the quality inspection of clinical chemical in vitro diagnostic reagents (boxes) (hereinafter referred to as "reagents (boxes)"), including terms and definitions, classification and naming, requirements, test methods, labels and instructions for use, packaging, Transport and storage. This standard applies to in vitro diagnostic reagents (boxes) based on the principle of spectrophotometry used in medical laboratories for quantitative testing of clinical chemistry items. This standard does not apply to: a) Performance evaluation reagents (such as reagents for research use only); b) POCT (point-of-care rapid test) clinical chemical in vitro diagnostic reagents.

GB/T 26124-2011 Referenced Document

GB 3100 SI units and recommendations for the use of their multiples and of certain other units
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY/T 0638 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials