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JB/T 20184-2017 English PDF

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JB/T 20184-2017: Bacterial endotoxin tester
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JB/T 20184-2017169 Add to Cart 3 days Bacterial endotoxin tester Valid

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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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