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JB/T 20190-2018 English PDF

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JB/T 20190-2018: Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine
Status: Valid
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JB/T 20190-2018English329 Add to Cart 3 days [Need to translate] Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine Valid JB/T 20190-2018

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Basic data

Standard ID JB/T 20190-2018 (JB/T20190-2018)
Description (Translated English) Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine
Sector / Industry Mechanical & Machinery Industry Standard (Recommended)
Classification of Chinese Standard C92
Classification of International Standard 11.120.30
Word Count Estimation 14,189
Date of Issue 2018-07-04
Date of Implementation 2019-01-01
Regulation (derived from) Ministry of Industry and Information Technology Announcement No. 36 of 2018
Issuing agency(ies) Ministry of Industry and Information Technology
Summary This standard specifies the terms and definitions, abbreviations, markings, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of the inner-sealed infusion bag (bottle) blow-fill seal (BFS) machine. This standard applies to the inner-sealed infusion bag (bottle) blow-fill seal (BFS) one machine.

JB/T 20190-2018: Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine

---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.
(Interior wall with shell powder decorative wall material) ICS 11.120.30 C92 Record number. 64811-2018 People's Republic of China pharmaceutical machinery industry standard Inner sealed infusion bag (bottle) blowing and sealing (BFS) machine Published on.2018-07-04 2019-01-01 implementation Ministry of Industry and Information Technology of the People's Republic of China

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009 "Standardization Work Guide Part 1. Standard Structure and Compilation". This standard was proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356). This standard was drafted. Hunan Qianshan Pharmaceutical Machinery Co., Ltd. The main drafters of this standard. Liu Yan, Hao Xiaofang, Shen Zhifeng, Liu Kun, Chen Cheng. Inner sealed infusion bag (bottle) blowing and sealing (BFS) machine

1 Scope

This standard specifies the terms and definitions, abbreviations, markings, requirements, and test methods of the inner-sealed infusion bag (bottle) blow-fill seal (BFS) machine. Law, inspection rules, signs, instructions for use, packaging, transportation and storage. This standard applies to the inner-sealed infusion bag (bottle) blow-filling seal (BFS) integrated machine (hereinafter referred to as the one-piece machine).

2 Normative references

The following documents are indispensable 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 191 packaging storage and transportation icon GB 5226.1-2008 Mechanical electrical safety machinery and electrical equipment - Part 1. General technical conditions GB/T 6388 transport packaging receipt and delivery mark GB/T 9969 General guidelines for the use of industrial products GB/T 10111 random number generation and its application in product quality sampling inspection GB/T 13306 signage General technical conditions for GB/T 13384 mechanical and electrical product packaging GB/T 16292-2010 Test method for suspended particles in clean room (zone) of the pharmaceutical industry GB/T 16769 metal cutting machine noise sound pressure level measurement method JB/T 20188-2017 Pharmaceutical machinery product model preparation method YBB00012002-2015 low density polyethylene infusion bottle YBB00022002-2015 polypropylene infusion bottle YY/T 0114-2008 Polyethylene special materials for medical infusion, blood transfusion and infusion YY/T 0242-2007 Polypropylene special materials for medical infusion, blood transfusion and infusion "Good Manufacturing Practices" (2010 revised) Ministry of Health of the People's Republic of China Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Inner sealed infusion bag (bottle) innersealedinfusionbag/bottle Under the condition of Class A air shower protection, the sealed container formed by the blowing, filling and sealing processes is completed in the same sealed mold at one time. 3.2 Self-emptying automaticemptyingliquid During the infusion use, the infusion bag (bottle) is automatically discharged through the infusion device without passing air.

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