CN107974402A - Liquid bacterial rejection tests method and system -0.2 μm of normal pore size air filter - Google Patents

Liquid bacterial rejection tests method and system -0.2 μm of normal pore size air filter Download PDF

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CN107974402A
CN107974402A CN201711468733.8A CN201711468733A CN107974402A CN 107974402 A CN107974402 A CN 107974402A CN 201711468733 A CN201711468733 A CN 201711468733A CN 107974402 A CN107974402 A CN 107974402A
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constant
air filter
pressure tank
pore size
filter
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施燕平
王文庆
郝树彬
秦杰
王科镭
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Shandong Quality Inspection Center for Medical Devices
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Shandong Quality Inspection Center for Medical Devices
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    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
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Abstract

0.2 μm of normal pore size of liquid bacterial rejection tests method and system air filter, including constant-pressure tank, connected at the top of constant-pressure tank by air inlet pipe with the gas outlet of air pump, pressure gauge is set on constant-pressure tank, it is located in constant-pressure tank equipped with challenge bacterium solution, the inlet communication of normal pore size 0.2 μm air filter of the constant-pressure tank by outlet tube and for examination, 0.2 μm of normal pore size air filter in filtrate collection bottle, flow valve is set on outlet tube, and the import of outlet tube is located at constant pressure pot bottom.The advantage of the invention is that:The filter effect of 0.2 μm of normal pore size air filter to be measured under worst case can be tested, help people to evaluate the bacterium ability of shutting off air filter, it is ensured that it meets harsh use demands of medical equipment such as infusion, blood transfusion apparatus etc..

Description

Liquid bacterial rejection tests method and system -0.2 μm of normal pore size air filter
Technical field
Shut off the present invention relates to a kind of medical air filter liquid bacterium and detect pilot system and method, specifically A kind of liquid bacterial rejection tests method and system -0.2 μm of normal pore size air filter.
Background technology
The method of some evaluation pneumatic filter interception capacities is currently, there are, mainly includes liquid bacterial rejection tests, gas Colloidal sol bacterium rejection tests and aerosol virus rejection tests etc..Liquid bacterial rejection tests are first to use the liquid of low surface tension Body soaks hydrophobic membrane filtration in advance, then referring again to the bacterium rejection tests method of degerming level liquid medicine filter/film, uses About 0.3 μm ~ 0.4 μm of diameter, the defects of being about 0.6 μm ~ 1.0 μm shortwave monad(ATCC 19146)Bacteria suspension carry out Challenge.Correspondingly, reference fluids aseptic filtration, current most of manufacturers will meet the sky of liquid bacterial rejection tests requirement Air filter is nominally 0.22 μm.Due to the difference of strobe utility, the liquid ratio of precision gas precision of filter is low, has tested The filter for proving that bacteriophage/virus can be retained in aerosol challenge can not retain bacteriophage/disease in liquid challenge Poison.It can be said that liquid bacterial challenge experiment can represent the degerming worst case of gas filtration.
The content of the invention
Liquid bacterial is carried out the object of the present invention is to provide a kind of air filtration to 0.2 μm of normal pore size to shut off retrieval examination The system and method tested, it can evaluate filter capacity of the filter to be measured under worst case.
The present invention to achieve the above object, is achieved through the following technical solutions:Including constant-pressure tank, at the top of constant-pressure tank by into Tracheae is connected with the gas outlet of air pump, and pressure gauge is set on constant-pressure tank, challenge bacterium solution is housed, constant-pressure tank is by going out liquid in constant-pressure tank The inlet communication of pipe and the 0.2 μm of air filter in normal pore size for examination, 0.2 μm of normal pore size air filter, which is located at, to be filtered out In liquid receiving flask, flow valve is set, the import of outlet tube is located at constant pressure pot bottom on outlet tube.The filtrate collection bottle includes Bottle, bottle side wall install one-way exhaust valve, bottleneck ring are installed at bottle upper opening, installs lid on bottleneck ring, lid leads to Cross screw thread to be connected with bottleneck ring, bottleneck ring internal perisporium bottom sets internal projecting ring, and supporting plate, supporting plate, lid are set on internal projecting ring Cavity is surrounded jointly with the side wall of bottleneck ring, the annular liquid capsule of installation in cavity, hydraulically full, the annular liquid capsule center of circle in annular liquid capsule Open up first through hole on lid above position, the second through hole, outlet tube are opened up on the supporting plate below annular liquid capsule center location It is inserted into successively by first through hole, annular liquid capsule and the second through hole inside bottle, supporting plate top surface opens up groove, bottom portion of groove installation Contact switch, contact switch top sets movable plate, spring is installed between movable plate and bottom portion of groove, when movable plate moves down, bullet Spring compresses, and movable plate can press the contact of contact switch, when movable plate moves up, spring-relaxation, movable plate and contact switch Contact separation, supporting plate bottom surface set contact chip, and contact chip is connected by circuit with contact switch, and convex top surface of ring border sets ring Shape contact, when supporting plate is placed on internal projecting ring, contact chip can set control with annular contact pad and turning in bottleneck ring Device, controller are connected by circuit with annular contact, and controller can be controlled by the open and-shut mode of electric circuit inspection contact switch Device is connected with signal transmission line and power circuit.Blind hole is opened up on the bottleneck ring inner wall, electric pushrod, electricity are installed in blind hole Dynamic push rod is connected by circuit with controller, and controller can control the flexible of electric pushrod, the movable boom end of electric pushrod Baffle is installed, baffle can move under the driving of electric pushrod in blind hole, and during electric pushrod extended configuration, baffle is positioned at blind The opening in hole is contacted with annular liquid capsule, and during electric pushrod contraction state, baffle can be withdrawn inside blind hole.
Liquid bacterial is carried out using the pilot system as described in claim 1-3 to 0.2 μm of normal pore size air filter to cut The method of experiment is stayed to include the following steps:
1. bacteria suspension of the injection no less than 2400mL defect shortwave monads ATCC 19146 is as challenge bacterium solution into constant-pressure tank It is spare;
2. booster air pump is slowly inflated into constant-pressure tank, after the rise of constant pressure pressure inside the tank, challenge bacterium solution slowly enters outlet tube, goes out After the air filter filtering of 0.2 μm of normal pore size, filter liquor enters in filtrate collection bottle challenge bacterium solution in liquid pipe;
3. carrying out membrane filtration using membrane-filter procedure to the filter liquor in filtrate collection bottle, analysis filter membrane is transferred to tablet On Count Agar, cultivated in 28 DEG C of -32 DEG C of environment, clump count was recorded at 72h and the 7th day;
4. the clump count of 72h and the 7th day record 3. recorded to step calculates log decreasing value(LRV), to the liquid of air filter Body bacteriological filter ability is evaluated.
The advantage of the invention is that:Mistake that can be to 0.2 μm of normal pore size air filter to be measured under worst case Filter effect is tested, and helps people to evaluate the bacterium ability of shutting off air filter, it is ensured that it meets infusion, blood transfusion Harsh use demand of the medical equipments such as device etc..
Brief description of the drawings
Fig. 1 is the structure diagram of the present invention;
Fig. 2 is I portions enlarged structure schematic diagram in Fig. 1;
Fig. 3 is that outlet tube is not inserted into the structure diagram in bottle in structure shown in Fig. 2;
Fig. 4 is the structure diagram of another embodiment of the present invention.
Embodiment
Liquid bacterial rejection tests system of the present invention -0.2 μm of normal pore size air filter includes constant-pressure tank 202, the top of constant-pressure tank 202 is connected by air inlet pipe 209 with the gas outlet of air pump 201, and pressure gauge 204 is set on constant-pressure tank 202, Pass through outlet tube 210 and 0.2 μm of the normal pore size air filter for examination equipped with challenge bacterium solution, constant-pressure tank 202 in constant-pressure tank 202 206 inlet communication, 0.2 μm of normal pore size air filter 206 are located in filtrate collection bottle 208, are set on outlet tube 210 Flow valve 205 is put, the import of outlet tube 210 is located at 202 bottom of constant-pressure tank.Before test, inject and be no less than into constant-pressure tank The bacteria suspension of 2400mL defect shortwave monads ATCC 19146 is as challenge bacterium solution.During test, by for the normal pore size 0.2 of examination The import of μm air filter 206 is docked with outlet tube 210, and 0.2 μm of normal pore size air filter 206 is placed in and is filtered out In liquid receiving flask 208, then booster air pump is slowly inflated into constant-pressure tank, and after the rise of constant pressure pressure inside the tank, challenge bacterium solution is slow Into outlet tube, for the challenge bacterium solution in outlet tube after 0.2 μm of normal pore size air filter filters, filter liquor enters filter liquor In receiving flask.Tester can carry out membrane filtration to the filter liquor in filtrate collection bottle using membrane-filter procedure, will analyze Filter membrane is transferred on plate count agar, is cultivated in 28 DEG C of -32 DEG C of environment, and clump count was recorded at 72h and the 7th day, and right The clump count calculates log decreasing value LRV, and the liquid bacterial filter capacity of air filter is evaluated.The present invention can be right The filter effect of 0.2 μm of normal pore size air filter to be measured under worst case is tested, and helps people to air mistake Filter evaluates the bacterium ability of shutting off, it is ensured that it meets harsh use demands of medical equipment such as infusion, blood transfusion apparatus etc..
Since the test process of the present apparatus is longer, air pump 201 is usually not required to staff after starting and aside observes, this hair The bright microorganism in order to avoid in environment enters in bottle between outlet tube 210 and filtrate collection bottle 208, influences test knot Fruit, can use following structures:The filtrate collection bottle 208 includes bottle 300,300 side wall of bottle installation one-way exhaust valve 303, bottleneck ring 1 is installed at 300 upper opening of bottle, lid 2 is installed on bottleneck ring 1, lid 2 is matched somebody with somebody by screw thread and bottleneck ring 1 Connection is closed, 1 internal perisporium bottom of bottleneck ring sets internal projecting ring 7, sets supporting plate 8 on internal projecting ring 7, supporting plate 8, lid 2 and bottleneck ring 1 Side wall surrounds cavity 9 jointly, the annular liquid capsule 10 of installation in cavity 9, hydraulically full in annular liquid capsule 10, annular 10 center of circle of liquid capsule position Put and first through hole 301 is opened up on the lid 2 of top, the second through hole is opened up on the supporting plate 8 below annular 10 center location of liquid capsule 302, outlet tube 210 is inserted into inside bottle 300 by first through hole 301,10 and second through hole 302 of annular liquid capsule successively, supporting plate 8 Top surface opens up groove 11,11 bottom of groove installation contact switch 12, and the top of contact switch 12 sets movable plate 23, movable plate 23 with Spring 24 is installed, when movable plate 23 moves down, spring 24 compresses, and movable plate 23 can press contact switch 12 between 11 bottom of groove Contact, when movable plate 23 moves up, 24 diastole of spring, the contact separation of movable plate 23 and contact switch 12,8 bottom surface of supporting plate is set Contact chip 13, contact chip 13 are connected by circuit with contact switch 12, and 7 top surface border of internal projecting ring sets annular contact 14, supporting plate 8 When being placed on internal projecting ring 7, contact chip 13 can contact and turn on annular contact 14, and controller 15, control are set in bottleneck ring 1 Device 15 processed is connected by circuit with annular contact 14, controller 15 can by the open and-shut mode of electric circuit inspection contact switch 12, Controller 15 is connected with signal transmission line and power circuit.After outlet tube 112 is inserted into 300 inside of bottle, annular liquid capsule 10 is certainly The softness and resilient characteristic of body can be such that it is fitted close with 112 outer wall of outlet tube, realize good sealing, one-way exhaust valve 303 Go out gas in bottle 300 for entering 300 heel row of bottle in filter liquor or challenge suspension, the side wall of outlet tube 112 is from annular The inner side of liquid capsule 10, which forms annular liquid capsule 10, to be extruded, and annular liquid capsule 10 protrudes Compressive activities plate 23, movable plate 23 at groove 11 The elastic force of spring 24 is overcome to be moved to 12 side of contact switch, by the contact of moving contact switch 12, controller 15 detects at this time The contact of contact switch 12 is pressed, judge 112 side wall of outlet tube with annular 10 tight fit inside of liquid capsule, sealing performance Well.If outlet tube 112 is pulled out or surprisingly deviates from inside bottle 300 during experiment, the annular inner side of liquid capsule 10 is Pressure is lost, liquid capsule 10 reduces the pressure of movable plate 23, and movable plate 23 leaves contact switch under the elastic force effect of spring 24 12, controller 15 detects that the contact of contact switch 12 is upspring, and judges that the sealing at annular liquid capsule 10 is destroyed, this test number According to accuracy can not ensure that can not be used as Appreciation gist, controller 15 can send alarm signal and record warning message.Such as The sealing that controller 15 is not detected by annular liquid capsule 10 in whole test process goes wrong, then the result of this test can It is higher by property, the effect of the air filter retention bacterium of the batch can be evaluated according to the test result.
The present invention avoids warning function failure from causing bottle close in order to carry out self-test to the warning function of controller 15 Fail to find so as to influencing test result in time during envelope failure, can open up blind hole 19 on 1 inner wall of bottleneck ring, in blind hole 19 Electric pushrod 20 is installed, electric pushrod 20 is connected by circuit with controller 15, and controller 15 can control electric pushrod 20 Flexible, the movable boom end installation baffle 21 of electric pushrod 20, baffle 21 can be under the driving of electric pushrod 20 in blind hole 19 Interior movement, during 20 extended configuration of electric pushrod, the opening that baffle 21 is located at blind hole 19 is contacted with annular liquid capsule 10, electric pushrod During 20 contraction state, baffle 21 can be withdrawn inside blind hole 19.Electric pushrod 20 is in extended configuration, when needing self-test, work usually Making personnel can be shunk by signal line remote control electric pushrod 20, baffle 21 is retracted to inside blind hole 19, at this time blind hole The annular liquid capsules 10 of 19 openings can be to prominent inside blind hole 19, and 23 pressure of the movable plate reduction in groove 11, movable plate 23 exists Contact switch 12 is left under the elastic force effect of spring 24, such as controller 15 normally sends alarm at this time, then judges warning function work Make normal.After self-test, remote control electric push rod 20 recovers extended configuration, and baffle 21 pushes back the annular liquid capsule 10 for blasting blind hole 19 The opening of blind hole 19,23 pressure of the movable plate increase in groove 11, movable plate 23 overcome the elastic force of spring 24 to contact switch 12 sides are moved, and press the contact of contact switch 12.Controller 15 does not send alarm normally during such as self-test, then judges warning function Abnormal state, this test result can not be used as Appreciation gist.
The method that pilot system of the present invention carries out liquid bacterial rejection tests to 0.2 μm of normal pore size air filter Include the following steps:
1. bacteria suspension of the injection no less than 2400mL defect shortwave monads ATCC 19146 is as challenge bacterium into constant-pressure tank 202 Liquid is spare;
2. booster air pump 201 is slowly inflated into constant-pressure tank 202, in constant-pressure tank 202 after pressure rise, challenge bacterium solution slowly enters Outlet tube 210, after 0.2 μm of normal pore size air filter 206 filters, filter liquor enters the challenge bacterium solution in outlet tube 210 In filtrate collection bottle 208;
3. carrying out membrane filtration using membrane-filter procedure to the filter liquor in filtrate collection bottle 208, analysis filter membrane is transferred to On plate count agar, cultivated in 28 DEG C of -32 DEG C of environment, clump count was recorded at 72h and the 7th day;
4. the clump count of 72h and the 7th day record 3. recorded to step calculates log decreasing value(LRV), to the liquid of air filter Body bacteriological filter ability is evaluated.
Above-mentioned steps can carry out the filter effect of 0.2 μm of normal pore size air filter to be measured under worst case Test, helps people to evaluate the bacterium ability of shutting off air filter, it is ensured that it meets that infusion, blood transfusion apparatus etc. are medical and sets Standby harsh use demand etc..In the test method, the measurement direction of air filter is filters from inside to outside, except this method Outside, the test method of ecto-entad can also be used:As shown in figure 4,402 He of constant-pressure tank is set in the air outlet pipe 403 of air pump 401 Flow valve 409, sets on constant-pressure tank 402 and pressure gauge 404 is set on constant-pressure tank 402, and air outlet pipe 403 and a fluid reservoir 405, are stored up Equipped with challenge suspension in flow container 405,407 are put in fluid reservoir 405 for 0.2 μm of the normal pore size air filter of examination, and be dipped in Under the liquid level for challenging suspension, the slave fluid reservoir 405 that 0.2 μm of normal pore size air filter puts 407 is pierced by and filter liquor receipts Collection bottle 408 connects.During test, air pump 401 is pumped into air into fluid reservoir 405, passes through the challenge suspension in fluid reservoir 405 and supplies 0.2 μm of the normal pore size air filter of examination puts 407, and into filtrate collection bottle 408, tester is to filtrate collection bottle Filter liquor in 208 carries out membrane filtration using membrane-filter procedure, analysis filter membrane is transferred on plate count agar, 28 Cultivated in DEG C -32 DEG C of environment, recorded clump count at 72h and the 7th day, you can ability of shutting off to air filter to bacterium carries out Evaluation.

Claims (4)

1. liquid bacterial rejection tests system -0.2 μm of normal pore size air filter, it is characterised in that:Including constant-pressure tank (202), constant-pressure tank(202)Top passes through air inlet pipe(209)With air pump(201)Gas outlet connection, constant-pressure tank(202)Upper setting Pressure gauge(204), constant-pressure tank(202)It is interior that challenge bacterium solution, constant-pressure tank are housed(202)Pass through outlet tube(210)With supplying the nominal of examination 0.2 μm of aperture air filter(206)Inlet communication, 0.2 μm of normal pore size air filter(206)Received positioned at filter liquor Collect bottle(208)It is interior, outlet tube(210)Upper setting flow valve(205), outlet tube(210)Import be located at constant-pressure tank(202)Bottom Portion.
2. liquid bacterial rejection tests system according to claim 1-0.2 μm of normal pore size air filter, its feature It is:The filtrate collection bottle(208)Including bottle(300), bottle(300)Side wall installs one-way exhaust valve(303), bottle (300)Bottleneck ring is installed at upper opening(1), bottleneck ring(1)Upper installation lid(2), lid(2)Pass through screw thread and bottleneck ring (1)It is connected, bottleneck ring(1)Internal perisporium bottom sets internal projecting ring(7), internal projecting ring(7)Upper setting supporting plate(8), supporting plate(8)、 Lid(2)And bottleneck ring(1)Side wall surround cavity jointly(9), cavity(9)The interior annular liquid capsule of installation(10), annular liquid capsule (10)It is interior hydraulically full, annular liquid capsule(10)Lid above center location(2)On open up first through hole(301), annular liquid capsule (10)Supporting plate below center location(8)On open up the second through hole(302), outlet tube(210)Pass through first through hole successively (301), annular liquid capsule(10)With the second through hole(302)It is inserted into bottle(300)Inside, supporting plate(8)Top surface opens up groove(11), it is recessed Groove(11)Bottom is installed by contact switch(12), contact switch(12)Top sets movable plate(23), movable plate(23)With groove (11)Spring is installed between bottom(24), movable plate(23)When moving down, spring(24)Compression, movable plate(23)Can be by lower contact Switch(12)Contact, movable plate(23)When moving up, spring(24)Diastole, movable plate(23)With contact switch(12)Contact point From supporting plate(8)Bottom surface sets contact chip(13), contact chip(13)Pass through circuit and contact switch(12)Connection, internal projecting ring(7)Top Face border sets annular contact(14), supporting plate(8)It is placed on internal projecting ring(7)When upper, contact chip(13)Can be with annular contact (14)Contact and turn on, bottleneck ring(1)Interior setting controller(15), controller(15)Pass through circuit and annular contact(14)Even Connect, controller(15)Electric circuit inspection contact switch can be passed through(12)Open and-shut mode, controller(15)With signal transmission line Connected with power circuit.
3. liquid bacterial rejection tests system according to claim 2-0.2 μm of normal pore size air filter, its feature It is:The bottleneck ring(1)Blind hole is opened up on inner wall(19), blind hole(19)Interior installation electric pushrod(20), electric pushrod(20) Pass through circuit and controller(15)Connection, controller(15)Electric pushrod can be controlled(20)Flexible, electric pushrod(20)'s Movable boom end installs baffle(21), baffle(21)Can be in electric pushrod(20)Driving under in blind hole(19)Interior movement, electricity Dynamic push rod(20)During extended configuration, baffle(21)Positioned at blind hole(19)Opening and annular liquid capsule(10)Contact, electric pushrod (20)During contraction state, baffle(21)Blind hole can be withdrawn(19)It is internal.
4. liquid bacterial retention is carried out to 0.2 μm of normal pore size air filter using the pilot system as described in claim 1-3 The method of experiment, it is characterised in that:Include the following steps:
1. to constant-pressure tank(202)Bacteria suspension of the interior injection no less than 2400mL defect shortwave monads ATCC 19146 is as challenge Bacterium solution is spare;
2. booster air pump(201)To constant-pressure tank(202)Interior slowly inflation, constant-pressure tank(202)After interior pressure rise, challenge bacterium solution is delayed Slow-motion enters outlet tube(210), outlet tube(210)Interior challenge bacterium solution is through 0.2 μm of normal pore size air filter(206)Filtering Afterwards, filter liquor enters filtrate collection bottle(208)It is interior;
3. to filtrate collection bottle(208)Interior filter liquor carries out membrane filtration using membrane-filter procedure, by analysis filter membrane transfer To plate count agar, cultivated in 28 DEG C of -32 DEG C of environment, clump count was recorded at 72h and the 7th day;
4. the clump count of 72h and the 7th day record 3. recorded to step calculates log decreasing value(LRV), to the liquid of air filter Body bacteriological filter ability is evaluated.
CN201711468733.8A 2017-12-29 2017-12-29 Liquid bacterial rejection tests method and system -0.2 μm of normal pore size air filter Pending CN107974402A (en)

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Publication number Priority date Publication date Assignee Title
CN108744988A (en) * 2018-08-15 2018-11-06 河南省医疗器械检验所 Air filtering device for transfusion/film liquid bacterial interception capacity experimental test component
CN109126475A (en) * 2018-08-15 2019-01-04 河南省医疗器械检验所 A kind of liquid bacterial interception capacity detection method of air filtering device for transfusion/film
CN109238943A (en) * 2018-10-17 2019-01-18 迈博瑞生物膜技术(南通)有限公司 A kind of positive press filtration device bacteria particles object interception capacity testing tool

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CN204087398U (en) * 2014-09-03 2015-01-07 贵州电网公司信息通信分公司 A kind of walling crib formula well lid monitoring alarm triggered device
CN204428579U (en) * 2015-01-05 2015-07-01 张茂 Tracheal inserting device

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US20070164058A1 (en) * 2005-12-15 2007-07-19 Igor Burkovskiy Pouring apparatus for carbonated beverages in bottles
CN103537195A (en) * 2012-07-12 2014-01-29 上海中立德医药科技有限公司 Germ entrapping detection apparatus and method by virtue of filter
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Publication number Priority date Publication date Assignee Title
CN108744988A (en) * 2018-08-15 2018-11-06 河南省医疗器械检验所 Air filtering device for transfusion/film liquid bacterial interception capacity experimental test component
CN109126475A (en) * 2018-08-15 2019-01-04 河南省医疗器械检验所 A kind of liquid bacterial interception capacity detection method of air filtering device for transfusion/film
CN109126475B (en) * 2018-08-15 2021-08-27 河南省医疗器械检验所 Method for detecting liquid bacteria interception capability of air filter/membrane for transfusion
CN108744988B (en) * 2018-08-15 2023-10-24 河南省药品医疗器械检验院(河南省疫苗批签中心) Air filter/membrane liquid bacteria interception capability test module for transfusion
CN109238943A (en) * 2018-10-17 2019-01-18 迈博瑞生物膜技术(南通)有限公司 A kind of positive press filtration device bacteria particles object interception capacity testing tool

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Application publication date: 20180501