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GB/T 36118-2018: Filter elements of pleated polytetrafluoroethylene microfiltration membrane for gas sterilizing
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GB/T 36118-2018: Filter elements of pleated polytetrafluoroethylene microfiltration membrane for gas sterilizing

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Filter elements of pleated polytetrafluoroethylene microfiltration membrane for gas sterilizing ICS 71.120; 23.100.60 J77 National Standards of People's Republic of China Gas sterilizing PTFE microfiltration membrane Folding filter Published by.2018-03-15 2018-10-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration released Directory Preface III 1 Scope 1 2 Normative references 1 3 Terms, definitions and abbreviations 1 3.1 Terms and Definitions 1 3.2 Abbreviations 2 4 Category 2 5 Request 3 5.1 Appearance 3 5.2 Bacterial Retention 3 5.3 Leakage 3 5.4 Integrity 3 5.5 Resistance 4 5.6 steam sterilization times 4 5.7 Hot Air Resistance 4 5.8 Oxidant Resistance 4 6 Test method 4 6.1 appearance 4 6.2 Bacterial Retention 4 6.3 Leakage 5 6.4 Integrity 6 6.5 Resistance 8 6.6 steam sterilization times 10 6.7 Hot Air Resistance 11 6.8 Oxidant Resistance 12 7 Inspection Rules 12 7.1 Batch Rules 12 7.2 Inspection Classification 12 7.3 Factory Inspection 12 7.4 Type Inspection 13 8 Identification, Packaging, Transport and Storage 13 8.1 Logo 13 8.2 Packaging 14 8.3 Transportation and Storage 14 Appendix A (informative annex) Bubble point pressure and bacterial challenge level 15 Appendix B (informative annex) Diffusion flow and bacterial challenge levels 17 Appendix C (informative annex) Water intrusion and bacterial challenge levels 19 Appendix D (Informative) Test Example of Hot Air Resistance Test 21 Reference 22

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Separation Membrane Standardization Technical Committee (SAC/TC382). This standard was drafted by. Shanghai Yiming Filtration Technology Co., Ltd., Hangzhou Annuo Filtration Equipment Co., Ltd., Renmin University of China, Chinese Institute of Medical Equipment, PLA Institute of Military Medical Sciences, Tianjin University of Technology, Hangzhou Qiushi Film Technology Co., Ltd., Tianjin Membrane Film Project Technology Co., Ltd. The main drafters of this standard. Wu Changfei, Zhang Junwei, Zheng Xiang, Liu Hongbin, Wang Jie, Zhang Xingxing, Zhang Sihan, Lu Zhongbao, Fan Yunshuang, Yang Yilin. Gas sterilizing PTFE microfiltration membrane Folding filter

1 Scope

This standard stipulates the classification, requirements, test methods, and inspection rules for PTFE microfiltration membrane folded filter cartridges (hereinafter referred to as “filter cartridges”). Then, identification, packaging, transportation and storage. This standard applies to gas sterilizing folded PTFE micro filter cartridge filter cartridge, also applicable to gas sterilization with folded PTFE Allen microfiltration membrane filter.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 packaging, storage and transportation logo GB/T 6165-2008 HEPA filter performance test method efficiency and resistance GB/T 7141-2008 Thermal aging test method for plastics YY/T 0918-2014 Liquid filtration membrane, liquid filter, bacterial retention test method YY/T 1551.1-2017 Air filter for infusion and blood transfusion apparatus - Part 1. Aerosol bacterial retention test method Pharmacopoeia of the People's Republic of China (2015 edition) 3 Terms, definitions and abbreviations 3.1 Terms and Definitions The following terms and definitions apply to this document. 3.1.1 Folded filter element filterelementsofpleatedmembrane A flat-plate microfiltration membrane is a filter element formed in a folded form. 3.1.2 Cartridge filter cartridgefilter A cylindrical filter element consisting of a filter membrane and other structural materials and that is used in conjunction with the housing through an interface. [GB/T 34244-2017, definition 3.1.2] 3.1.3 Capsule filter capsulefilter A capsule filter element consisting of a filter membrane and other structural materials with a plastic housing on the outside. [GB/T 34244-2017, definition 3.1.3] 3.1.4 Log reduction value Under the specified conditions, the common logarithm of the ratio of the number of microorganisms before filtration to the filtered liquid or gas to the number of filtered microorganisms. ...