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YY/T 1648-2019: Methods of establishing correlation between bubble point pressure and bacterial retention ability of filters for medical infusion equipments Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1648-2019: Methods of establishing correlation between bubble point pressure and bacterial retention ability of filters for medical infusion equipments---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1648-2019 Methods of establishing correlation between bubble point pressure and bacterial retention ability of filters for medical infusion equipments ICS 11.040.20 C31 People's Republic of China Pharmaceutical Industry Standard Bubble point pressure and bacteria retention of filters for infusion devices Ability association method Methodsofestablishingcorrelationbetweenbubblepointpressureandbacterial Retentionabilityoffiltersformedicalinfusionequipments Published on.2019-05-31 2020-06-01 implementation State Drug Administration issued ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Hangzhou Annuo Filtration Equipment Co., Ltd., Hangzhou Ke Baite Filter Equipment Co., Ltd., Pall Filter (Beijing) Co., Ltd. The main drafters of this standard. Xu Hui, Zhang Junwei, Jiang Shuping, Liu Hongyan, Wu Ping, Wang Wenqing, Mon Qing, Zhao Dan.introductionThe filtration performance test of the liquid filter and the air filter for the infusion device can be carried out by physical integrity test and bacterial retention test. Ways. The characteristics of the former type of test are simple and time-consuming, but the test results can only indirectly reflect the filtration performance of the product. The product process inspection project, the representative test is the bubble point pressure test and the water breakthrough method test; the latter type of test is characterized by direct reflection of the product Bacterial retention performance, but the method is complex, time-consuming, high cost, high requirements for inspection facilities and inspection personnel, suitable for type inspection projects, Representative test methods are liquid bacterial retention test and aerosol bacterial retention test. It should be noted that this standard only provides a method for correlating the bubble point pressure with the bacteria retention capacity for the filter for infusion devices. Filters for infusion sets are not required to establish a correlation between bubble point pressure and bacterial retention capacity when performing integrity testing, only when When using the bubble point test results as the daily control standard for the filter integrity project for infusion sets, the bubble point test results need to be followed. This standard can only be used if it is associated with the results of the bacteria retention test. See Appendix A for further description of specific test operations. Bubble point pressure and bacteria retention of filters for infusion devices Ability association method1 ScopeThis standard specifies the bubble point pressure and bacteria of the liquid filter (including the infusion circuit on the blood transfusion device) and the air filter. The method of establishing the ability to intercept. This standard applies to correlating the bubble point pressure of a filter for an infusion set with the ability to retain bacteria.2 Normative referencesThe 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 edition (including all amendments) applies to this document. YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention YY/T 0929.1 Infusion filter for infusion - Part 1. Liquid filter integrity test YY/T 0929.2 Liquid filter for infusions - Part 2. Capsules of Candida albicans with a nominal pore size of 1.2 μm method Air filters for infusion and blood transfusion devices - Part 1 . Methods Air filters for infusion and blood transfusion devices - Part 2. Methods Air filters for infusion and blood transfusions - Part 3. Methods of completeness test3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Bubble point bubblepointvalue (BPi) When the physical integrity test is performed, as the pressure increases, the first bubble is observed on the test sample and the criticality of continuous bubble generation is guided. Pressure value. Note. When near the bubble point, it is easier to obtain a precise bubble point pressure value by slowly applying the test pressure. 3.2 Bubble point lower limit bubblepointlowerlimitvalue(BP0) The minimum value of the bubble point of all samples in the filter sample that meet the bacterial retention requirements. 3.3 Associated bubble point pressure correlatedbubblepointpressure(BPmin) Multiply the lower limit of the bubble point by a value derived from a safety factor. Note. This value is the final result report value of the association study and is used as a technical indicator for the passage of bacterial retention by the filter. 3.4 Overall population The entirety of the filter of the same type (see Table 1) made of at least 3 batches of film. Note. Three batches of membranes refer to different batches of membranes of the same manufacturer and with the same pore size, feedstock and process. YY/T 1648-2019 Methods of establishing correlation between bubble point pressure and bacterial retention ability of filters for medical infusion equipments ICS 11.040.20 C31 People's Republic of China Pharmaceutical Industry Standard Bubble point pressure and bacteria retention of filters for infusion devices Ability association method Methodsofestablishingcorrelationbetweenbubblepointpressureandbacterial Retentionabilityoffiltersformedicalinfusionequipments Published on.2019-05-31 2020-06-01 implementation State Drug Administration issuedForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This standard was drafted. Shandong Medical Device Product Quality Inspection Center, Hangzhou Annuo Filtration Equipment Co., Ltd., Hangzhou Ke Baite Filter Equipment Co., Ltd., Pall Filter (Beijing) Co., Ltd. The main drafters of this standard. Xu Hui, Zhang Junwei, Jiang Shuping, Liu Hongyan, Wu Ping, Wang Wenqing, Mon Qing, Zhao Dan.introductionThe filtration performance test of the liquid filter and the air filter for the infusion device can be carried out by physical integrity test and bacterial retention test. Ways. The characteristics of the former type of test are simple and time-consuming, but the test results can only indirectly reflect the filtration performance of the product. The product process inspection project, the representative test is the bubble point pressure test and the water breakthrough method test; the latter type of test is characterized by direct reflection of the product Bacterial retention performance, but the method is complex, time-consuming, high cost, high requirements for inspection facilities and inspection personnel, suitable for type inspection projects, Representative test methods are liquid bacterial retention test and aerosol bacterial retention test. It should be noted that this standard only provides a method for correlating the bubble point pressure with the bacteria retention capacity for the filter for infusion devices. Filters for infusion sets are not required to establish a correlation between bubble point pressure and bacterial retention capacity when performing integrity testing, only when When using the bubble point test results as the daily control standard for the filter integrity project for infusion sets, the bubble point test results need to be followed. This standard can only be used if it is associated with the results of the bacteria retention test. See Appendix A for further description of specific test operations. Bubble point pressure and bacteria retention of filters for infusion devices Ability association method1 ScopeThis standard specifies the bubble point pressure and bacteria of the liquid filter (including the infusion circuit on the blood transfusion device) and the air filter. The method of establishing the ability to intercept. This standard applies to correlating the bubble point pressure of a filter for an infusion set with the ability to retain bacteria.2 Normative referencesThe 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 edition (including all amendments) applies to this document. YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention YY/T 0929.1 Infusion filter for infusion - Part 1. Liquid filter integrity test YY/T 0929.2 Liquid filter for infusions - Part 2. Capsules of Candida albicans with a nominal pore size of 1.2 μm method Air filters for infusion and blood transfusion devices - Part 1 . Methods Air filters for infusion and blood transfusion devices - Part 2. Methods Air filters for infusion and blood transfusions - Part 3. Methods of completeness test3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Bubble point bubblepointvalue (BPi) When the physical integrity test is performed, as the pressure increases, the first bubble is observed on the test sample and the criticality of continuous bubble generation is guided. Pressure value. Note. When near the bubble point, it is easier to obtain a precise bubble point pressure value by slowly applying the test pressure. 3.2 Bubble point lower limit bubblepointlowerlimitvalue(BP0) The minimum value of the bubble point of all samples in the filter sample that meet the bacterial retention requirements. 3.3 Associated bubble point pressure correlatedbubblepointpressure(BPmin) Multiply the lower limit of the bubble point by a value derived from a safety factor. Note. This value is the final result report value of the association study and is used as a technical indicator for the passage of bacterial retention by the filter. 3.4 Overall population The entirety of the filter of the same type (see Table 1) made of at least 3 batches of film. Note. Three batches of membranes refer to different batches of membranes of the same manufacturer and with the same pore size, feedstock and process. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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