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GB/T 34244-2017: Technical code for liquid sterilizing-grade filter elements
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GB/T 34244-2017: Technical code for liquid sterilizing-grade filter elements

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Technical code for liquid sterilizing-grade filter elements ICS 71.120; 23.100.60 J77 National Standards of People's Republic of China Liquid sterilization filter technology requirements 2017-09-07 Posted 2018-04-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and Definitions, Abbreviations 1 3.1 Terms and definitions 1 3.2 Abbreviations 3 4 Requirements 3 4.1 Appearance 3 4.2 Biosafety 3 4.3 Extractable mass 3 4.4 bacterial retention capacity 3 4.5 Integrity 3 4.6 flux 3 4.7 steam sterilization times 4 4.8 maximum operating pressure 4 4.9 cleanliness 4 4.10 Endotoxin release 4 5 test methods 4 5.1 Appearance 4 5.2 Biosafety 4 5.3 Extractable quality 4 5.4 bacteria retention capacity 6 5.5 Integrity 6 5.6 flux 9 5.7 steam sterilization 10 5.8 Maximum operating pressure 11 5.9 cleanliness 13 5.10 Endotoxin release 14 6 Inspection rules 16 6.1 test classification 16 6.2 factory inspection 16 6.3 type test 16 7 Identification, Packaging, Transport and Storage 17 7.1 logo 17 7.2 Packaging 18 7.3 Transport and storage 18 Appendix A (Informative) Correlation of Integrity Test Parameters to Bacterial Challenge Levels, Relationship between Pressure Decay and Diffusion Flow 19 Appendix B (informative) flux test results calculation 23 References 26

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard by the National Standardization Technical Committee membrane separation (SAC/TC382) and focal point. This standard was drafted unit. Shanghai Yat Ming Filter Technology Co., Ltd., Hangzhou Annuo Filter Equipment Co., Merck Chemical Technology (Shanghai) Co., Co., Ltd., Tianjin Polytechnic University, Hainan Lishui Water Technology Industry Co., Ltd., Beijing Bishuiyuan Membrane Technology Co., Ltd., Tianjin Membrane Division Technology Co., Ltd. The main drafters of this standard. Wuchang Fei, Wang Xin, Zhang Junwei, Sheng Ping, Wang Jie, Chen Qing, Li Tianyu, Wang Yang, Hu Xiaoyu, Fan Yun double, Tang Xiaoshan. Liquid sterilization filter technology requirements

1 Scope

This standard specifies the technical requirements, test methods, inspection rules, labeling, packaging, Transport and storage. This standard applies to the filter aperture is not greater than 0.22μm liquid sterilization grade cartridge filter and capsule filter.

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 14233.2-2005 Medical infusion, transfusion, injection apparatus test methods Part 2. Biological test methods GB/T 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples GB/T 20878 stainless steel and heat-resistant steel grades and chemical composition YY/T 0918 liquid filtration membrane, liquid filter bacterial retention test method The People's Republic of China Pharmacopoeia.2015 edition 3 Terms and Definitions, Abbreviations 3.1 Terms and definitions The following terms and definitions apply to this document. 3.1.1 Pore poresize Filter pore size characterized by specific microbial retention. 3.1.2 Cartridge filter cartridgefilter A cylindrical filter element consisting of a filter and other structural materials that mates with the housing through an interface. 3.1.3 Capsule filter capsulefilter Capsule filter element made of filter membrane and other structural materials and externally with a plastic housing. 3.1.4 Extractables Under extreme conditions (such as organic solvents, extreme high temperatures, ionic strength, pH, contact time, etc.), the extract from the filter all the material Contact surface extraction of chemical components. 3.1.5 Logreductionvalue log reduction value Under specified conditions, the filtered liquid was filtered before the number of microorganisms and the number of microorganisms after filtration than the common logarithm. ...