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YY/T 1793-2021: (Bacterial endotoxin determination kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1793-2021 | English | 199 |
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(Bacterial endotoxin determination kit)
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YY/T 1793-2021
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Basic data | Standard ID | YY/T 1793-2021 (YY/T1793-2021) | | Description (Translated English) | (Bacterial endotoxin determination kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 9,970 | | Issuing agency(ies) | State Drug Administration | YY/T 1793-2021: (Bacterial endotoxin determination kit)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Bacterial endotoxin determination kit)
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Bacterial Endotoxin Assay Kit
Published on 2021-09-06
2023-03-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This standard was drafted by. Tianjin Sino Biopharmaceutical Co., Ltd., Beijing Medical Device Inspection Institute, Beijing Medical Device Technology Review
Center, Shanghai Clinical Laboratory Center, Beijing Jinshanchuan Technology Development Co., Ltd., Dana (Tianjin) Biotechnology Co., Ltd., Zhanjiang Bokanghai
Ocean Biological Co., Ltd.
The main drafters of this standard. Zang Danrong, Yang Zhong, Sun Rong, Wang Jinghua, He Yongsheng, Wang Baoxue, Mo Jingshen.
Bacterial Endotoxin Assay Kit
1 Scope
This standard specifies the requirements, test methods, labeling, labeling, instructions for use, packaging, transportation and storage of bacterial endotoxin assay kits
and so on.
This standard applies to the quantitative detection of bacterial endotoxins produced by Gram-negative bacteria in human serum and plasma based on the principle of Limulus reagent spectrophotometry.
test kit. The chemical composition of bacterial endotoxin is phospholipid polysaccharide-protein complex, and lipopolysaccharide is the component of bacterial endotoxin.
This standard is also applicable to the quantitative detection of Gram-negative bacteria lipopolysaccharide in human serum and plasma based on the principle of Limulus reagent spectrophotometry
kit.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use
3 Requirements
3.1 Appearance
Appropriate appearance requirements should be specified according to the packaging characteristics of the product. Generally, the composition and properties of each component of the kit should be included; inner and outer packaging, labels
requirements for clarity etc.
a) The kit should have complete components, the inner and outer packaging should be complete, and the labels should be clear;
b) There is no leakage of liquid reagents; the lyophilized components are loose bodies, and the liquid is clear after reconstitution (no particles visible to the naked eye, no precipitation).
3.2 Loading capacity
Should meet one of the following requirements.
a) For single-serve liquid reagents that do not need to be extracted and tested by direct sample addition, the deviation of the net content of the liquid reagents should not exceed ±5%;
b) For multiple doses of liquid reagents, the net content of the liquid reagents should not be less than the indicated value.
3.3 Accuracy
Should meet one of the following requirements.
a) Relative deviation. should not exceed ±20%;
b) Recovery rate. should be in the range of 80%~120%.
3.4 Linear
The manufacturer should specify the linear interval of the kit and meet the following requirements.
a) The upper limit of the linear range of the kit should not be lower than 0.16EU/mL, and the lower limit should not be higher than 0.04EU/mL;
b) The linear correlation coefficient |r| shall not be less than 0.980.
Note. If the enterprise adopts the mass unit, the conversion relationship between the mass unit and the EU unit shall be clearly indicated.
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