Search result: YY/T 1551.3-2017
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Air filters for medical infusion and transfusion equipments—Part 3: Integrity test methods
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YY/T 1551.3-2017
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| Standard ID | YY/T 1551.3-2017 (YY/T1551.3-2017) | | Description (Translated English) | Air filters for medical infusion and transfusion equipments--Part 3: Integrity test methods | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,165 | | Date of Issue | 2017-02-28 | | Date of Implementation | 2018-01-01 | | Drafting Organization | Shandong Medical Device Quality Inspection Center, Hangzhou Branch Baxter Filter Equipment Co., Ltd., Shanghai Zhenpu Medical Equipment Co., Ltd., Hangzhou Annuo Filter Equipment Co., Ltd., Shandong Zhongbokang Medical Appliance Co., Ltd., Shandong Xinhua Andean Medical Products Co., Ltd. Company, Pall Filter (Beijing) Co., Ltd., Wuhan Zhixun ChuangYuan Technology Development Co., Ltd. | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 25 | | Issuing agency(ies) | State Food and Drug Administration |
YY/T 1551.3-2017
Air filters for medical infusion and transfusion equipments-Part 3. Integrity test methods
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Infusion, blood transfusion device with air filter
Part 3. Integrity test methods
Part 3.Integritytestmethods
2017-02-28 Posted
2018-01-01 implementation
State Food and Drug Administration released
Foreword
YY/T 1551 "infusion, blood transfusion device with air filter" consists of the following components.
--- Part 1. Aerosol bacterial retention test method;
--- Part 2. Liquid bacterial retention test method;
--- Part 3. Integrity test methods.
This part of YY/T 1551 Part 3.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This part of the National Medical Infusion utensils Standardization Technical Committee (SAC/TC106) centralized.
This section mainly drafted unit. Shandong Province Medical Device Quality Inspection Center, Hangzhou Branch Baxter Filter Equipment Co., Ltd., Shanghai Zhen
Pu Medical Equipment Co., Ltd., Hangzhou Annuo Filter Equipment Co., Ltd., Shandong Zhongbokang Medical Appliance Co., Ltd., Shandong Xinhua Ande Medical
Supplies Co., Ltd., Pall Filter (Beijing) Co., Ltd., Wuhan Zhixun ChuangYuan Technology Development Co., Ltd.
The main drafters of this section. Nie Jiaqi, Xu Hui, Bao Shan, Yu Yanwen, Li Wenkai, Gong Jiafu, Li Wenchao, Tang Yan, Guo Wei, Luo Yong, Wu Qiyu.
introduction
For direct confirmation of infusion, blood transfusion devices with air filters to prevent the environment into the transfusion of microorganisms, blood transfusion system, a common method
Liquid bacterial retention test and aerosol bacterial retention test two. The former is the first air filter in the filter by a special treatment, and then press
Similar to the bacteriostasis-type liquid filter bacterial retention test method with a diameter of 0.3μm ~ 0.4μm, length 0.6μm ~ 1.0μm defects
Pseudomonas bacteria challenge test, the specific test methods see the second part of this standard; the latter is the average particle diameter of about
3μm microbial aerosol simulation of clinical conditions of use challenge test, the specific test methods, see YY/T 1551 Part 1.
Air filters that pass the aerosol bacterial entrapment test are thought to effectively filter out airborne microbial aerosols. For nominal membrane pores
The air filter with a diameter of 0.22 μm must meet the more stringent bacterial entrapment test requirements.
As the bacterial retention test method is more complicated, and the requirements of the test conditions and personnel to operate high, the general does not apply to the air filter
Routine control test. Conventional control tests may use non-destructive physical integrity tests that have established correlation with the bacterial retention test
Methods, such as bubble point pressure method. The air filter physical integrity test carried out on the premise that the air filter can withstand the corresponding bacteria interception test
A correlation filter membrane bubble pressure was established. Bubble-point pressure, established on the basis of studies related to bacterial entrapment tests, can be used as infusion, transfusion
Air bubble filter with integrity check bubble pressure. If the air filter integrity check bubble point pressure is lower than the membrane bubble point pressure, still with fine
Bacteria retention test to establish correlation.
At present, infusion, blood transfusion devices with air filters are mainly air intake devices, liquid filter on the vent and other infusion, blood transfusion devices
On the exhaust and other types. This standard mainly to the intake device, liquid filter on the vent as an example to establish air filter integrity
experiment method.
Infusion, blood transfusion device with air filter
Part 3. Integrity test methods
1 Scope
YI/T 1551 provisions of this part of the infusion, blood transfusion device with air filter integrity test methods, including bubble point pressure test and water
Breakthrough/penetration test.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Outside outside
The air filter of the infusion set is exposed to the side of the air environment when in use.
2.2
Inside inside
The other side of the infusion set's air filter, opposite the outside.
3 state conditioning and test environment
The sample should be conditioned for 24 h at (23 ± 2) ° C ambient temperature and (50 ± 5)% relative humidity and conditioned under conditions of conditioning
test.
NOTE Sterilization of the filter will have some effect on the integrity of the filter, and the integrity test should be performed on the sterilized product.
4 bubble point pressure test
4.1 principle
Air filters wetted with a suitable wetting fluid (see Appendix A), the filter membrane of which is wetted, immersed in a test medium (water or other moistened
Wet liquid), a predetermined gas pressure (bubble point depression limit value) is applied from the inside thereof, and whether or not an air flow passes is observed from the outside.
4.2 wetting
Apply a suitable amount of a suitable wetting fluid (see A.1.1) to both sides of the air filter with a syringe to allow the filter membrane to fully wet.
NOTE When using water as the bubble point pressure test medium, a syringe pre-filled with purified water is used to inject a suitable amount of air from the inside of the air filter
Purified water Rinse the filter lumen and filter membrane (over the membrane rinse) to fully remove the wetting fluid. See A.1.2.
4.3 test layout
The air filter after 4.2 wetting arrangement test system according to FIG. The cavity volume of the test system should be as small as possible to stabilize the pressure.
Also avoid pipe twisting in the test system.
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