JB/T 20190-2018Inner sealed infusion bag/bottle Blow-Fill-Seal (BFS) integrated machine (English PDF)
内封式输液袋(瓶)吹灌封（BFS）一体机
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Issued by
MIIT
Level / Type
Industry · Recommended
Issue date
July 4, 2018
Implementation date
January 1, 2019
Scope
JB/T 20190-2018 is the English-translated version of 内封式输液袋(瓶)吹灌封（BFS）一体机.
JB/T 20190-2018 is the Chinese standard "Inner sealed infusion bag/bottle Blow-Fill-Seal (BFS) integrated machine". Its scope clause reads: 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). Its clauses include terms and definitions.
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Document preview — JB/T 20190-2018
National Standard of the People's Republic of China
Issued by: Ministry of Industry and Information Technology of the People's Republic of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 3.1 Inner sealed infusion bag (bottle)
- 3.2 Self-emptying automaticemptyingliquid
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)
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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