YYT 1513-2017 Industry Standard On C-reactive Protein Testing Kit

Preface
This standard is drafted in accordance with the rules given in GB/T1.1-2009.Please note that some of
the contents of this document may involve patents. The issuing organization of this document is not
responsible for identifying these patents. This standard was proposed by the National Medical
Product Administration. This standard is under the jurisdiction of the National Medical Clinical
Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SEC/TC 136).
This standard was drafted: Beijing Medical Device Inspection Institute, Zhongsheng North Control
Biotechnology Co., Ltd., Beijing Jiuqiang Biotechnology Unit Co., Ltd., Xisen Meikang Biotechnology
(Wuxi) Co., Ltd., Shanghai Rongsheng Biological Pharmaceutical Co., Ltd.
The main drafters of this standard: Wang Ruixia, Xia Youchao, Zhang Xiaorui, Dai Leiying, Zhang Jie,
Zhang Zhengqiang.
YY/T1513-2017
C-reactive protein assay kit
1 Range
This standard specifies the classification, requirements, test methods and signs, labels, instructions for
use, packaging, and transportation of C-reactive protein assay kits.
This standard is applicable to the kit for quantitative determination of C-reactive protein in blood
samples based on the reaction of antigen-antibody reaction (hereinafter referred to as: CRP kit),
including quantitative labeling immunoassays [e.g. (electro) chemiluminescence] and
immunoturbidimetry (e.g. Immunoturbidimetry, Strong immune turbidimetry)
This standard does not apply to:
1) Evaluation of C-reactive protein calibrators and controls.
2) Various types of colloidal gold-labeled test strips.
2 Normative reference
The following documents are indispensable for the application of this document. For dated references,
only dated versions apply to this article.
For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon.
GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement
calibrator and control substance assignment value measurement traceability.
GB/T 2979L2 in vitro diagnostic medical device manufacturers (labeling) Part 2: Professional in vitro
diagnostic reagents