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Basic data | Standard ID | JB/T 20200-2021 (JB/T20200-2021) | | Description (Translated English) | (Filter integrity tester) | | Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) | | Classification of Chinese Standard | C95 | | Word Count Estimation | 15,12 | | Issuing agency(ies) | Ministry of Industry and Information Technology |
JB/T 20200-2021: (Filter integrity 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.
(Filter integrity tester)
ICS 11.120.30
CCSC95
Record number. 83809-2021
People's Republic of China Machinery Industry Standard
Filter Integrity Tester
Published on 2021-08-21
2022-02-01 Implementation
Published by the Ministry of Industry and Information Technology of the People's Republic of China
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Mark 2
5 Requirements 2
6 Test method 3
7 Inspection rules9
8 Logo, instruction manual, packaging, transportation and storage 10
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is proposed by China Pharmaceutical Equipment Industry Association.
This document is under the jurisdiction of the National Standardization Technical Committee of Pharmaceutical Equipment (SAC/TC356).
This document is drafted by. Zhejiang Tailin Biotechnology Co., Ltd., Beijing Niuyin Huaxin Technology Development Co., Ltd.
The main drafters of this document. Zhu Liang, Ye Wuqing, Wang Ruodong, Wang Xiaojun, Dai Shengqun.
Filter Integrity Tester
1 Scope
This document specifies the terms and definitions, markings, requirements, test methods, inspection rules, and markings, use of filter integrity testers
Instructions, packaging, transportation and storage.
This document applies to testers for non-destructive integrity testing of cartridge filters, membrane filters, etc. (hereinafter referred to as "testers").
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 4208-2017 Protection class of enclosure (IP code)
GB/T 6388 Receipt and Delivery Marks for Transport Packaging
GB/T 9969 General Principles of Instruction Manual for Industrial Products
GB/T 10111 Generation of random numbers and its application in product quality sampling inspection
GB/T 13306 Signs
GB/T 13384 General technical conditions for packaging of mechanical and electrical products
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 36035-2018 General requirements for electrical safety of pharmaceutical machinery
Pharmacopoeia of the People's Republic of China (Announcement No. 78 [2020] of the National Health Commission of the State Food and Drug Administration)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
bubblepoint
The maximum required for continuous extrusion of gas from the largest membrane pores in a well-wetted porous membrane to form a continuous steady or large amount of gas.
little pressure.
3.2
forwardflow
diffusionflow
When a gas pressure below the bubble point is applied, the gas molecules diffuse through the well-wetted membrane pores to the gas flow downstream of the filter membrane.
3.3
water intrusion
Measures the "apparent" water flow resulting from a small but measurable drop in liquid level at pressures below water breakthrough (where water is forced through).
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