CN109439531B - Be applied to aseptic inspection's of medical instrument product device - Google Patents
Be applied to aseptic inspection's of medical instrument product device Download PDFInfo
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- CN109439531B CN109439531B CN201811332503.3A CN201811332503A CN109439531B CN 109439531 B CN109439531 B CN 109439531B CN 201811332503 A CN201811332503 A CN 201811332503A CN 109439531 B CN109439531 B CN 109439531B
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- 238000007689 inspection Methods 0.000 title claims abstract description 32
- 239000007788 liquid Substances 0.000 claims abstract description 31
- 238000007789 sealing Methods 0.000 claims abstract description 16
- 238000012546 transfer Methods 0.000 claims abstract description 15
- 239000012530 fluid Substances 0.000 claims description 5
- 230000001580 bacterial effect Effects 0.000 claims 2
- 238000000034 method Methods 0.000 abstract description 32
- 230000001954 sterilising effect Effects 0.000 abstract description 22
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 21
- 238000012360 testing method Methods 0.000 abstract description 18
- 230000008569 process Effects 0.000 abstract description 17
- 238000001514 detection method Methods 0.000 abstract description 15
- 239000011521 glass Substances 0.000 abstract description 14
- 239000003480 eluent Substances 0.000 abstract description 12
- 230000002829 reductive effect Effects 0.000 abstract description 11
- 238000002360 preparation method Methods 0.000 abstract description 8
- 238000012864 cross contamination Methods 0.000 abstract description 7
- 239000000047 product Substances 0.000 description 42
- 241001411320 Eriogonum inflatum Species 0.000 description 12
- 241000894006 Bacteria Species 0.000 description 8
- 238000010828 elution Methods 0.000 description 8
- 230000010355 oscillation Effects 0.000 description 8
- 238000005406 washing Methods 0.000 description 6
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 239000012528 membrane Substances 0.000 description 5
- 239000002504 physiological saline solution Substances 0.000 description 4
- 238000010586 diagram Methods 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- 239000012085 test solution Substances 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000002572 peristaltic effect Effects 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 206010036790 Productive cough Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000013100 final test Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 238000009210 therapy by ultrasound Methods 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Public Health (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Examining Or Testing Airtightness (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The utility model provides a be applied to aseptic device that inspects of medical instrument product, includes the liquid collecting bag, and liquid collecting bag one end is equipped with sealing device, and the other end is equipped with the bottle plug, and the bottle plug is used for linking to each other with film filter. Compared with the prior art, the sterile detection device is simple and convenient to operate, can be used immediately, and does not need sterilization treatment; the preparation procedure of the product to be tested, namely the eluent, is simplified, the product to be tested does not need to be transferred into a glass bottle after being eluted by a sterilization transfer container, and the operation is simple and easy to be carried out; the method has the advantages that the operation is simplified, the probability of cross contamination in the test process is reduced, the false positive rate in the test process is greatly reduced, and the sterile inspection is easier to succeed.
Description
Technical Field
The patent relates to the field of medical instruments and relates to the field of biological detection, in particular to a device applied to sterile inspection of medical instrument products.
Background
According to the existing inspection technical scheme, according to requirements of a general rule 1101 aseptic inspection method of the pharmacopoeia of the people's republic of China (2015 edition), the equipment and experimental articles used in the aseptic inspection are emphasized more, the aseptic operation level of inspection personnel and the control capability of a laboratory disinfection and sterilization process are emphasized more, and due to the difference of personnel capability and laboratory disinfection and sterilization management capability, the risk of uncontrollable cross contamination in the aseptic inspection process of medical equipment is high, the false positive probability of an aseptic inspection result is high, the final test is failed, and the laboratory detection capability is affected very negatively.
The technical scheme of the prior art is generally summarized as follows: 1. preparing a test device for sterile inspection, such as a glass bottle, a capping machine, a plug cover, a transfer container and the like, wherein the products all need to be sterilized in advance, the sterilization process and the parameter setting are different due to laboratory instrument configuration, and the general principle is to ensure that the test device reaches a sterility assurance level after sterilization. 2. Transferring the sterilized instrument and the medical instrument product to be detected to a clean workbench or a biosafety cabinet, sterilizing the surface of the product to be detected, opening the package, transferring the product to be detected to a sterilized transfer container, adding a certain amount of sterile normal saline, performing oscillation elution, transferring the eluent to a glass bottle in a sterile mode after the elution is completed, adding a plug, and capping. 3. After the aseptic sleeve is packaged and sterilized, the aseptic sleeve is opened, the aseptic sleeve is mounted on a bacteria collecting instrument, and then the aseptic sleeve is connected with a glass bottle, and eluent is filtered by a film filter for aseptic detection. 4. Subsequent operations refer to pharmacopoeia sterility-checking procedures. The defects of the prior art are that 1, the sterilization treatment link of the test device for the sterile inspection is complicated in experimental preparation, high in labor intensity, incomplete in sterilization in the high-pressure steam sterilization process and the like, false positive in the sterile inspection process can be caused, and the sterile inspection is failed. 2. After the sterilization of the test device for the sterile inspection, in the process of preparing the product test liquid in the clean cabinet or the biosafety cabinet, the operation procedure is complicated, the requirement on the sterile operation capability is high, the requirements on personnel are severe, the cross contamination in the test process is easy to cause the false positive of the sterile inspection, and the sterile inspection fails.
Disclosure of Invention
In order to solve the technical problem, the patent provides a device applied to sterile inspection of medical instrument products. The method can simplify the preparation procedure of the product to be tested and the test solution, so that the operation is concise.
The technical proposal of the patent is as follows,
the utility model provides a be applied to aseptic inspection's of medical instrument product device, includes the liquid collecting bag, and liquid collecting bag one end is equipped with sealing device, and the other end is equipped with the bottle plug, and the bottle plug is used for linking to each other with aseptic inspection with film filter.
The sterile detection device and the medical instrument product to be detected are placed in a clean cabinet or a biological safety cabinet, the medical instrument product to be detected is disassembled, sterile operation is performed, a sealing device of a liquid collecting bag is opened, the medical instrument product to be detected is transferred into the liquid collecting bag, the sealing device is closed, and then the medical instrument product is subjected to oscillation elution in the liquid collecting bag by a certain amount of sterile normal saline. And (3) packaging and sterilizing the sterile sleeve, opening the sterile sleeve after packaging and sterilizing, mounting the sterile sleeve on a bacteria collecting instrument, penetrating a sample injection needle of the film filter into a bottle stopper of the device, and performing subsequent operation according to a pharmacopoeia sterile inspection operation program. In the prior art, the medical instrument product to be detected is required to be transferred to a sterilized transfer container, a certain amount of sterile physiological saline is added for oscillation elution, and after the elution is finished, the eluent is transferred to a glass bottle in a sterile mode, and the glass bottle is plugged and capped. And after the sterile sleeve is connected with the glass bottle, the eluent is filtered by a membrane filter for sterile detection. Compared with the prior art, the sterile detection device is simple and convenient to operate, can be used immediately, and does not need sterilization treatment; the preparation procedure of the product to be tested, namely the eluent, is simplified, the product to be tested does not need to be transferred into a glass bottle after being eluted by a sterilization transfer container, and the operation is simple and easy to be carried out; the method has the advantages that the operation is simplified, the probability of cross contamination in the test process is reduced, the false positive rate in the test process is greatly reduced, and the sterile inspection is easier to succeed.
Further, the sealing device is a closure strip. Closure strips are commonly used sealing devices that are easy to open and close.
Further, the device also comprises a connecting port with a pump pipe, wherein the type of the connecting port comprises but is not limited to a luer connector, a dialyzer connector, an external circulation pipeline connector and the like, and the type of the connecting port comprises but is not limited to a luer connector, a dialyzer connector, an external circulation pipeline connector and the like. Some medical instrument products have inner cavities which are not easy to elute in the liquid collecting bag in a manual oscillation mode, and other medical instrument products only need to ensure the inner cavities to be sterile and only need to clean the inner cavities.
Further, the bottle stopper is a rubber bottle stopper. The rubber bottle plug can be repeatedly inserted into the hole without leakage. The bottle stopper contains a protective cap.
Compared with the prior art, the sterile detection device has the beneficial effects that the sterile detection device is simple and convenient to operate, is used immediately after being taken, and does not need sterilization treatment; the preparation procedure of the product to be tested, namely the eluent, is simplified, the product to be tested does not need to be transferred into a glass bottle after being eluted by a sterilization transfer container, and the operation is simple and easy to be carried out; the method has the advantages that the operation is simplified, the probability of cross contamination in the test process is reduced, the false positive rate in the test process is greatly reduced, and the sterile inspection is easier to succeed. The washing machine is suitable for washing the outer surface of the medical instrument product and also can be used for washing the interior which is not easy to wash in the medical instrument product, and is comprehensive in application.
Drawings
Fig. 1 is a schematic structural diagram of a first embodiment of the present patent.
Fig. 2 is a schematic view of a usage state of the first embodiment of the present disclosure.
Fig. 3 is a schematic structural diagram of a second embodiment of the present disclosure.
Fig. 4 is a schematic structural diagram of a third embodiment of the present patent.
The device comprises a liquid collecting bag 1, a sealing device 2, a bottle stopper 3, a sample injection needle 4, a membrane filter 5, a sterile sleeve 6, a bacteria collector 7, a hose 8, a pump pipe 9, a first adapter 10, a second adapter 11, a cannula 12 and a luer connector 13.
Detailed Description
This patent is further described below with reference to the accompanying drawings. Wherein the drawings are for illustrative purposes only and are shown in schematic, non-physical, and not intended to be limiting of the present patent; for the purpose of better illustrating the embodiments of the present patent, certain elements of the drawings may be omitted, enlarged or reduced and do not represent the actual product dimensions; it will be appreciated by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted.
Example 1
The device for sterile inspection of medical instrument products comprises a liquid collecting bag 1, wherein one end of the liquid collecting bag 1 is provided with a sealing device 2, and the sealing device 2 is a sealing strip. The closure strip is a common sealing device 2 which is easy to open and close. The other end of the liquid collecting bag 1 is provided with a bottle stopper 3, one end of a sample injection needle 4 penetrates through the bottle stopper 3 to be inserted into the liquid collecting bag 1, preferably, the bottle stopper 3 is a rubber bottle stopper, one end of the sample injection needle 4 is a plastic needle, and therefore the plastic needle is easier to insert into the rubber bottle stopper, the rubber bottle stopper can be repeatedly inserted into a hole, liquid is not leaked, and the bottle stopper 3 contains a protective cap.
The liquid collecting bag with the sealing strip comprises a plurality of specifications, the aspect ratio and the volume of the liquid collecting bag are in accordance with the situation of medical instrument sample preparation, the general volume is 400-800 mL, the liquid collecting bag is applied to the sterile inspection of medical instruments such as syringes and surgical gloves, and the liquid collecting bag with the long-strip-shaped volume of 400-800 mL is suitable for the sterile inspection of medical instruments such as trachea cannula and sputum suction tube.
As shown in fig. 2, the other end of the sample injection needle 4 is connected with the membrane filter 5. The membrane filter 5 is arranged on a sterile sleeve 6, and the sterile sleeve 6 is arranged on a bacteria collector 7.
The application steps of the sterile detection device of the patent are as follows: the sterile detection device and the medical instrument product to be detected are placed in a clean cabinet or a biosafety cabinet, the medical instrument product to be detected is disassembled, sterile operation is performed, the sealing device 2 of the liquid collecting bag 1 is opened, the medical instrument product to be detected is transferred into the liquid collecting bag 1, the sealing device 2 is closed, and then the medical instrument product is subjected to oscillation elution in the liquid collecting bag 1 by using a certain amount of sterile physiological saline, and the eluent is used as a test solution in the next step.
After the packaging sterilization treatment of the sterile sleeve 6, the sterile sleeve 6 is opened, the sterile sleeve 6 is mounted on the bacteria collector 7, the test solution is filtered through the directional peristaltic pressurization action of the bacteria collector 7, and after the filtration, the bacteria collector 7 performs sterile detection, and the subsequent operation refers to the pharmacopoeia sterile inspection operation program.
In the prior art, the medical instrument product to be detected is required to be transferred to a sterilized transfer container, a certain amount of sterile physiological saline is added for oscillation elution, and after the elution is finished, the eluent is transferred to a glass bottle in a sterile mode, and the glass bottle is plugged and capped. After the aseptic sleeve 6 is connected with a glass bottle, the eluent is filtered by a membrane filter 5 for aseptic detection. Compared with the prior art, the sterile detection device of the patent is simple and convenient to operate, can be used immediately, and the liquid collecting bag 1 does not need sterilization treatment; the preparation procedure of the product to be tested, namely the eluent, is simplified, the product to be tested does not need to be transferred into a glass bottle after being eluted by a sterilization transfer container, and the operation is simple and easy to be carried out; the method has the advantages that the operation is simplified, the probability of cross contamination in the test process is reduced, the false positive rate in the test process is greatly reduced, and the sterile inspection is easier to succeed.
Example two
Unlike the embodiment, the device further comprises a hose 8, a pump tube 9, a first adapter 10 and a second adapter 11. The first swivel port 10 is connected to the fluid collection bag 1 by a length of hose 8 and the second swivel port 11 is connected to the fluid collection bag 1 by a length of pump tubing 9. The first transfer interface 10 and the second interface can be matched with different instrument interfaces according to actual needs. Types of first transfer port 10, second transfer port 11 include, but are not limited to, luer ports, dialyzer ports, extracorporeal circulation line ports. Some medical instrument products have inner cavities which are not easy to elute in the liquid collecting bag 1 in a manual oscillation mode, and some medical instrument products only need to ensure the inner cavities to be sterile and only need to clean the inner cavities. This is the case for a first adapter 10 with hose 8 and a second adapter 11 with pump tube 9. In one embodiment, the second transfer port 11 with the pump tube 9 is connected with the liquid collecting bag 1 and the hose 8 with the first transfer port 10 to form a circulation pipeline, a peristaltic pump is adopted to drive the liquid to flow, the sterile physiological saline is eluted through the inner cavity of the medical instrument product, and in order to enhance the eluting effect, the pipeline can be placed on an oscillator for oscillation treatment or ultrasonic treatment in ultrasonic equipment or other devices which can enhance the eluting efficiency and have no inhibiting effect on the recovered bacteria.
Example III
Unlike the second embodiment, luer 13 is chosen as the adapter, cannula 12 is chosen as pump tube 9 or hose 8, luer 13 is connected to the fluid collection bag 1 by cannula 12. The cannula 12 protrudes from the opening closing strip of the drip bag 1. The third embodiment also aims at the situation that the inner cavity of some medical instrument products is not easy to be eluted in the liquid collecting bag 1 in a manual vibration mode and some medical instrument products only need to be cleaned.
The sterile detection device is simple and convenient to operate, can be used immediately after being taken, and the liquid collecting bag 1 does not need sterilization treatment; the preparation procedure of the product to be tested, namely the eluent, is simplified, the product to be tested does not need to be transferred into a glass bottle after being eluted by a sterilization transfer container, and the operation is simple and easy to be carried out; the method has the advantages that the operation is simplified, the probability of cross contamination in the test process is reduced, the false positive rate in the test process is greatly reduced, and the sterile inspection is easier to succeed. The washing machine is suitable for washing the outer surface of the medical instrument product and also can be used for washing the interior which is not easy to wash in the medical instrument product, and is comprehensive in application. In addition, the sterility test device can be used for testing medical equipment products, medicines, raw materials, intermediate products, accessories, workpieces and other biological load evaluation in the production process. The device does not need to be adjusted, and the application range is enlarged.
It is to be understood that the above examples of this patent are presented for purposes of illustration only and are not intended to limit the scope of the embodiments of this patent. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. Any modification, equivalent replacement, improvement, etc. that comes within the spirit and principles of the present patent should be included in the protection scope of the present patent claims.
Claims (4)
1. The utility model provides a be applied to aseptic device that inspects of medical instrument product, its characterized in that includes album liquid bag, film filter, advances needle, aseptic sleeve and collection bacterial instrument, album liquid bag one end is equipped with sealing device, and the other end is equipped with the bottle plug, and the bottle plug is used for linking to each other with film filter, advances needle one end and passes the bottle plug inserts album liquid bag, advances the needle other end and connects film filter, and film filter sets up on aseptic sleeve, and aseptic sleeve installs on collection bacterial instrument, sealing device is the closure strip, the bottle plug is the rubber bottle plug.
2. The device for sterile inspection of medical device products of claim 1, further comprising an adapter port with a pump tube, the adapter port being connected to the fluid collection bag by the pump tube.
3. The device for sterile inspection of medical device products of claim 1, further comprising an adapter port with a hose, the adapter port being connected to the fluid collection bag by the hose.
4. A device for the sterile inspection of medical device products according to claim 2 or 3, characterized in that the type of transfer port comprises a luer, a dialyzer port, an extracorporeal circulation line port.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811332503.3A CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811332503.3A CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109439531A CN109439531A (en) | 2019-03-08 |
| CN109439531B true CN109439531B (en) | 2023-12-08 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811332503.3A Active CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0014447A1 (en) * | 1979-02-05 | 1980-08-20 | Arvey Corporation | Sterilization pouch with insertable sterilization indicator |
| JP2000300245A (en) * | 1999-04-22 | 2000-10-31 | Sekisui Chem Co Ltd | Bag for examination |
| CN2856050Y (en) * | 2005-12-28 | 2007-01-10 | 广东环凯微生物科技有限公司 | Detection bag for microbes |
| CN101893589A (en) * | 2010-06-29 | 2010-11-24 | 中国人民解放军第三○二医院 | Sterility test method and totally closed bacteria collection ampoule incubator used thereby |
| CN105670916A (en) * | 2014-11-20 | 2016-06-15 | 华仁药业股份有限公司 | Fully closed membrane filter for sterile examination of sterile packaging interlayer and detection method of fully closed membrane filter |
| WO2018071732A1 (en) * | 2016-10-12 | 2018-04-19 | Verrix, Llc | Systems and methods for sterility assurance |
| WO2018091788A1 (en) * | 2016-11-15 | 2018-05-24 | Biron Jean Francois | Method for validating a sterilisation method comprising two successive contaminations |
| CN209481673U (en) * | 2018-11-09 | 2019-10-11 | 广东省医疗器械质量监督检验所 | A kind of device applied to medical device product sterility test |
-
2018
- 2018-11-09 CN CN201811332503.3A patent/CN109439531B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0014447A1 (en) * | 1979-02-05 | 1980-08-20 | Arvey Corporation | Sterilization pouch with insertable sterilization indicator |
| JP2000300245A (en) * | 1999-04-22 | 2000-10-31 | Sekisui Chem Co Ltd | Bag for examination |
| CN2856050Y (en) * | 2005-12-28 | 2007-01-10 | 广东环凯微生物科技有限公司 | Detection bag for microbes |
| CN101893589A (en) * | 2010-06-29 | 2010-11-24 | 中国人民解放军第三○二医院 | Sterility test method and totally closed bacteria collection ampoule incubator used thereby |
| CN105670916A (en) * | 2014-11-20 | 2016-06-15 | 华仁药业股份有限公司 | Fully closed membrane filter for sterile examination of sterile packaging interlayer and detection method of fully closed membrane filter |
| WO2018071732A1 (en) * | 2016-10-12 | 2018-04-19 | Verrix, Llc | Systems and methods for sterility assurance |
| WO2018091788A1 (en) * | 2016-11-15 | 2018-05-24 | Biron Jean Francois | Method for validating a sterilisation method comprising two successive contaminations |
| CN209481673U (en) * | 2018-11-09 | 2019-10-11 | 广东省医疗器械质量监督检验所 | A kind of device applied to medical device product sterility test |
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| CN109439531A (en) | 2019-03-08 |
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