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Bacterial endotoxin tester
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JB/T 20184-2017
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Basic data | Standard ID | JB/T 20184-2017 (JB/T20184-2017) | | Description (Translated English) | Bacterial endotoxin tester | | Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) | | Classification of Chinese Standard | C95 | | Word Count Estimation | 7,743 | | Date of Issue | 2017-04-12 | | Date of Implementation | 2017-10-01 | | Issuing agency(ies) | Ministry of Industry and Information Technology | | Summary | This standard specifies the terms and definitions, markings, requirements, test methods, inspection rules, marking, packaging, transportation and storage of bacterial endotoxin testers. |
JB/T 20184-2017: Bacterial endotoxin tester---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 analyzer)
ICS 11.120.30
C95
Filing number .58597-2017
People's Republic of China pharmaceutical machinery industry standards
Bacterial endotoxin detector
2017-04-12 released
2017-10-01 implementation
Ministry of Industry and Information Technology of the People's Republic of China
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009 "Standardization Guide Part 1. Standard Structure and Preparation".
This standard proposed by the China Pharmaceutical Equipment Industry Association.
This standard by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356) centralized.
This standard was drafted unit. Tianjin Tiantian Technology Co., Ltd., China Institute of Pharmaceutical and Biological Products, Tianjin Pharmaceutical Inspection
Inspection Institute.
The main drafters of this standard. Zhao Haishan, Li Xing, Gao Hua, Cai Tong, Rui Jing.
Bacterial endotoxin detector
1 Scope
This standard specifies the bacterial endotoxin detector marking, requirements, test methods, inspection rules, signs, packaging, transportation and storage.
This standard applies to the use of dynamic turbidimetry or dynamic colorimetric detection of bacterial endotoxin content of bacterial endotoxin detector (to
Hereinafter referred to as "tester"), but also for the detection of fungal-β-D glucan content.
2 Normative references
The following documents for the application of this document is essential. 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 191 Packaging - Pictorial signs
Mechanical and Electrical Safety Machinery - Electrical Equipment Part 1. General Technical Requirements
GB/T 13384 mechanical and electrical product packaging General technical conditions
GB/T 14710 medical appliances environmental requirements and test methods
Industrial machinery - Electrical equipment - Protective earthing continuity test code GB/T
Pharmaceutical machinery - Terminology GB/T 15692-2008
Calibration standards for bacterial endotoxin analyzers
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Terms and definitions
3.1
Optical density (OD) optical density
Optical density is the characterization of the light-shielding ability of a material, a dimensionless unit, which is the logarithm of the ratio of incident light to transmitted light or the light transmittance
Logarithms.
The formula is OD = lg (incident light/transmitted light) or OD = lg (1/light transmittance).
4 mark
4.1 model preparation
Function code. Detection equipment
XD
Type designation. Bacterial endotoxin test
Product Code. Tube hole number
4.2 Marking examples
Example .JXD24. Bacterial endotoxin meter showing 24 wells.
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