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YY/T 1551.3-2017 (YYT 1551.3-2017)

YY/T 1551.3-2017_English: PDF (YYT1551.3-2017)
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YY/T 1551.3-2017English199 Add to Cart 3 days Air filters for medical infusion and transfusion equipments—Part 3: Integrity test methods YY/T 1551.3-2017 Valid YY/T 1551.3-2017

BASIC DATA
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
Br