CN209481673U - A kind of device applied to medical device product sterility test - Google Patents
A kind of device applied to medical device product sterility test Download PDFInfo
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- CN209481673U CN209481673U CN201821845886.XU CN201821845886U CN209481673U CN 209481673 U CN209481673 U CN 209481673U CN 201821845886 U CN201821845886 U CN 201821845886U CN 209481673 U CN209481673 U CN 209481673U
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Abstract
A kind of device applied to medical device product sterility test, including liquid-collection bag, liquid-collection bag one end are equipped with sealing device, and the other end is equipped with bottle stopper, and bottle stopper with membrane filter for being connected.Compared with prior art, the Sterility testing device of this patent is easy to operate, brings and uses, liquid-collection bag is without sterilization treatment；The preparation procedure for simplifying product test liquid, that is, eluent to be measured does not need to be then transferred in vial after sterilizing transfer vessel elution, and operation is succinct, easy to get started；Simplify operation and also reduce the probability of cross contamination during test, the false positive rate during test is substantially reduced, so that sterility test is easier to be succeeded.
Description
Technical field
It is field of biological detection that this patent, which is related to medical instrument, and in particular to one kind is applied to medical device product without bacterial examination
The device looked into.
Background technique
Existing inspection technology scheme, according to the Pharmacopoeia of the People's Republic of China (version in 2015) general rule 1101 without bacterial examination
Method requirement is looked into, utensil and experimental article used in sterility test more emphasize reviewer's sterile working level and laboratory
The ability of sterilization process control leads to Medical treatment device due to the difference of personnel ability and laboratory sterilization managerial ability
Uncontrollable cross contamination risk is relatively high during tool sterility test, cause the false positive probability of sterility test result compared with
Height leads to final test failure, causes very negative impact to laboratory testing capability.
The technical solution of the prior art, General Introduction are as follows: 1, preparation sterility test test tool, such as vial,
Capping machine, corking, transfer vessel etc., articles described above are required to carry out sterilization treatment, sterilisation process and parameter in advance
Setting is variant because of Laboratory Instruments configuration, and test tool reaches sterility assurance level after the overall principle guarantees sterilizing. 2,
Utensil after sterilizing and medical device product to be detected are transferred in clean bench or Biohazard Safety Equipment, to product surface to be measured
It carries out disinfection after processing, opens packaging, by transferred product to be measured into the transfer vessel that sterilized, a certain amount of sterile physiological is added
Salt water carries out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial, jumps a queue, gland processing.3, right
After the processing of sterile sleeve package sterilization, sterile sleeve is opened, sterile sleeve is installed to germ collector, then by sterile sleeve and glass
Eluent is filtered through membrane filter after the connection of glass bottle, carries out Sterility testing.4, subsequent operation is referring to pharmacopeia sterility test
Operation sequence.Disadvantage of the prior art is that 1, sterility test test tool sterilization treatment link, Preparatory work of experiment is cumbersome, labor
The reasons such as fatigue resistance is big, and the sterilizing of high pressure steam sterilization process is not thorough, it will the false positive during sterility test is caused, so that
Sterility test failure.2, after sterility test is sterilized with test tool, product test liquid is carried out in cleaning cabinet or Biohazard Safety Equipment
In preparation process, operation sequence is cumbersome, and sterile working Capability Requirement is high, harsher to personnel requirement, be easy to cause and tested
Cross contamination in journey causes sterility test false positive, so that sterility test fails.
Summary of the invention
In order to solve the above technical problems, this patent provides a kind of device applied to medical device product sterility test.It
Product test liquid preparation procedure to be measured can be simplified, so that operation is succinct.
The technical solution of the patent is as follows,
A kind of device applied to medical device product sterility test, including liquid-collection bag, liquid-collection bag one end are equipped with sealing dress
It sets, the other end is equipped with bottle stopper, and bottle stopper with sterility test with membrane filter for being connected.
The Sterility testing device of this patent and medical device product to be detected are placed in cleaning cabinet or Biohazard Safety Equipment,
Medical device product to be detected is dismantled, the sealing device of liquid-collection bag is opened in sterile working, by medical device product to be detected
It is transferred in liquid-collection bag, then sealing device is closed, medical device product is in liquid-collection bag with a certain amount of sterile physiological later
Salt water carries out oscillation elution.To the processing of sterile sleeve package sterilization, sterile sleeve is opened after package sterilization processing, by sterile sleeve
On installation to germ collector, the sample introduction of membrane filter is needled into present apparatus bottle stopper, subsequent operation is grasped referring to pharmacopeia sterility test
Make program.It in existing technical solution, needs for medical device product to be detected to be transferred in the transfer vessel that sterilized, be added
A certain amount of sterile saline carries out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial, adds
Plug, gland processing.Sterile sleeve filters eluent through membrane filter after connecting with vial, carries out Sterility testing.It compares
The Sterility testing device of the prior art, this patent is easy to operate, brings and uses, liquid-collection bag is without sterilization treatment；Simplify production to be measured
Product test liquid, that is, eluent preparation procedure does not need to be then transferred in vial after sterilizing transfer vessel elution, operation letter
It is clean, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the false positive during test
Rate, so that sterility test is easier to be succeeded.
Further, the sealing device is sealing strip.Sealing strip is common sealing device, is easily opened and closes.
It further, further include the converting interface with pump line, interface type includes but is not limited to female Luer, dialyzer
Interface, extracorporeal circulation pipeline interface etc., with have hose converting interface, interface type include but is not limited to female Luer, thoroughly
Parser interface, extracorporeal circulation pipeline interface etc..The inner cavity of some medical device products is not easy in liquid-collection bag through oscillation by hand
Mode be eluted, also some medical device products only need to guarantee that inner cavity is sterile, it is only necessary to clean inner cavity.
Further, the bottle stopper is bottle closure of rubber.Bottle closure of rubber repeats jack, no leakage.Bottle stopper contains protective cap.
Compared with prior art, the beneficial effect of this patent is, the Sterility testing device of this patent is easy to operate, brings
It uses, liquid-collection bag is without sterilization treatment；The preparation procedure for simplifying product test liquid, that is, eluent to be measured does not need to shift in sterilizing
It is then transferred in vial after container elution, operation is succinct, easy to get started；Simplify operation and also reduces cross contamination during test
Probability, substantially reduce test during false positive rate so that sterility test is easier to be succeeded.It is not only suitable for elution doctor
Device product outer surface is treated, is readily applicable to be not easy the inside eluted in cleaning medical device product, be applicable in comprehensive.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of this patent embodiment one.
Fig. 2 is the use state diagram of this patent embodiment one.
Fig. 3 is the structural schematic diagram of this patent embodiment two.
Fig. 4 is the structural schematic diagram of this patent embodiment three.
It include liquid-collection bag 1, sealing device 2, bottle stopper 3, sample introduction needle 4, membrane filter 5, sterile sleeve 6, germ collector in figure
7, hose 8, pump line 9, the first converting interface 10, the second converting interface 11, intubation 12, female Luer 13.
Specific embodiment
This patent is further described below in conjunction with attached drawing.Wherein, only for illustration, expression is only for attached drawing
It is schematic diagram, rather than pictorial diagram, it should not be understood as the limitation to this patent；It is attached in order to which the embodiment of this patent is better described
Scheme certain components to have omission, zoom in or out, does not represent the size of actual product；It will be understood by those skilled in the art that attached
It is understandable that some well-known structures and descriptions thereof may be omitted in figure.
Embodiment one
A kind of device applied to medical device product sterility test, as shown in Figure 1, including liquid-collection bag 1, liquid-collection bag 1 one
End is equipped with sealing device 2, and the sealing device 2 is that the sealing device is sealing strip.Sealing strip is common sealing device 2,
It is easily opened and closes.1 other end of liquid-collection bag is equipped with bottle stopper 3, and 4 one end of sample introduction needle passes through the bottle stopper 3 and is inserted into liquid-collection bag 1, excellent
Selection of land, the bottle stopper 3 are bottle closure of rubber, and one end of sample introduction needle 4 is plastic spike, in this way, plastic spike is easier to insertion rubber
In bottle stopper, bottle closure of rubber repeats jack, no leakage, and bottle stopper 3 contains protective cap.
Liquid-collection bag with sealing strip includes several specifications, and length-width ratio and volume are more conform with medical instrument sample preparation
Situation, general volume are 400 ~ 800mL, are applied to syringe, the sterility test of the medical instruments such as surgical glove, strip character
The liquid-collection bag of 400 ~ 800mL volume be suitable for the sterility tests of the medical instruments such as trachea cannula, sputum aspirator tube.
As shown in Fig. 2, 4 other end of sample introduction needle connection membrane filter 5 is connected.Membrane filter 5 is arranged in sterile sleeve 6
On, sterile sleeve 6 is mounted on germ collector 7.
The use step of the Sterility testing device of this patent is: by the Sterility testing device of this patent and medical treatment to be detected
Device product is placed in cleaning cabinet or Biohazard Safety Equipment, dismantles medical device product to be detected, and liquid-collection bag is opened in sterile working
1 sealing device 2, medical device product to be detected is transferred in liquid-collection bag 1, then sealing device 2 is closed, medical later
Device product carries out oscillation elution with a certain amount of sterile saline in liquid-collection bag 1, and eluent is as next step for examination
Liquid.
After the package sterilization processing of sterile sleeve 6, sterile sleeve 6 is opened, sterile sleeve 6 is installed to germ collector 7,
Test liquid is filtered by the orientation wriggling pressurization of germ collector 7, after filtering, carries out Sterility testing by germ collector 7, subsequent
Operation is referring to pharmacopeia sterility test operation sequence.
In existing technical solution, needs for medical device product to be detected to be transferred in the transfer vessel that sterilized, add
Enter a certain amount of sterile saline, carry out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial,
It jumps a queue, gland processing.Sterile sleeve 6 filters eluent through membrane filter 5 after connecting with vial, carries out Sterility testing.
Compared with prior art, the Sterility testing device of this patent is easy to operate, brings and uses, and liquid-collection bag 1 is without sterilization treatment；Simplify to
Product test liquid, that is, eluent preparation procedure is surveyed, does not need to be then transferred in vial after sterilizing transfer vessel elution, grasp
Make succinctly, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the vacation during test
Positive rate, so that sterility test is easier to be succeeded.
Embodiment two
It further include hose 8, pump line 9, the first converting interface 10 and the second converting interface 11 unlike embodiment.First turn
Interface 10 is connected to liquid-collection bag 1 by one section of hose 8, and the second converting interface 11 is connected to liquid-collection bag 1 by one section of pump line 9.It is described
First converting interface 10 can match different instrument interfaces from second interface according to actual needs.First converting interface 10, the second converting interface
11 type includes but is not limited to female Luer, dialyzer interface, extracorporeal circulation pipeline interface.Some medical device products it is interior
Chamber is not easy to be eluted by way of vibrating by hand in liquid-collection bag 1, also some medical device products only need to guarantee inner cavity without
Bacterium, it is only necessary to clean inner cavity.The first converting interface 10 with hose 8 and the second converting interface 11 with pump line 9 are then needles
To such case.In one embodiment, the second converting interface 11 and liquid-collection bag 1, the hose containing the first converting interface 10 with pump line 9
8 connect into circulation line, flow liquid using peristaltic pump driving, allow inner cavity of the sterile saline by medical device product
It is eluted, elutes effect for enhancing, pipeline can be placed on oscillator and be carried out in oscillation treatment or ultrasonic device at ultrasound
Reason can enhance elution efficiency using other and not inhibit to handle in the device influenced on recycling bacterium.
Embodiment three
Unlike embodiment two, female Luer 13 is selected to be used as converting interface, intubation 12 is used as pump line 9 or hose 8, Shandong
Your interface 13 passes through intubation 12 and is connected to liquid-collection bag 1.Intubation 12 protrudes into from the closure of openings item of liquid-collection bag 1.Embodiment three
It is to be not easy to be eluted by way of vibrating by hand in liquid-collection bag 1 for the inner cavities of some medical device products, also some doctors
Treat the situation that device product only needs to clean inner cavity.
The Sterility testing device of this patent is easy to operate, brings and uses, and liquid-collection bag 1 is without sterilization treatment；Simplify production to be measured
Product test liquid, that is, eluent preparation procedure does not need to be then transferred in vial after sterilizing transfer vessel elution, operation letter
It is clean, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the false positive during test
Rate, so that sterility test is easier to be succeeded.Eluting medical device product external surfaces are not only suitable for, are readily applicable to clean
It is not easy the inside eluted in medical device product, is applicable in comprehensive.In addition, this sterility test device can not only be used to check medical treatment
Device product can also be used to check that the biological load of raw material in drug, with production process, intermediate product, accessory, workpiece etc. is commented
Estimate.Device does not need to adjust, and application range is expanded.
Obviously, above-described embodiment of this patent is only intended to clearly illustrate this patent example, and is not pair
The restriction of the embodiment of this patent.For those of ordinary skill in the art, may be used also on the basis of the above description
To make other variations or changes in different ways.There is no necessity and possibility to exhaust all the enbodiments.It is all this
Made any modifications, equivalent replacements, and improvements etc., should be included in patent claims within the spirit and principle of patent
Protection scope within.
Claims (3)
1. a kind of device applied to medical device product sterility test, which is characterized in that including liquid-collection bag, liquid-collection bag one end is set
There is sealing device, the sealing device is sealing strip, and the other end is equipped with bottle stopper, and bottle stopper with membrane filter for being connected；Also wrap
The converting interface with pump line is included, the converting interface connects liquid-collection bag by pump line；It further include the converting interface with hose, described turn
Interface connects liquid-collection bag by hose.
2. a kind of device applied to medical device product sterility test according to claim 1, which is characterized in that switching
The type of mouth includes female Luer, dialyzer interface, extracorporeal circulation pipeline interface.
3. a kind of device applied to medical device product sterility test according to claim 1, which is characterized in that described
Bottle stopper is bottle closure of rubber.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201821845886.XU CN209481673U (en) | 2018-11-09 | 2018-11-09 | A kind of device applied to medical device product sterility test |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201821845886.XU CN209481673U (en) | 2018-11-09 | 2018-11-09 | A kind of device applied to medical device product sterility test |
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| CN209481673U true CN209481673U (en) | 2019-10-11 |
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| CN201821845886.XU Active CN209481673U (en) | 2018-11-09 | 2018-11-09 | A kind of device applied to medical device product sterility test |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109439531A (en) * | 2018-11-09 | 2019-03-08 | 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 CN201821845886.XU patent/CN209481673U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109439531A (en) * | 2018-11-09 | 2019-03-08 | 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 |
| CN109439531B (en) * | 2018-11-09 | 2023-12-08 | 广东省医疗器械质量监督检验所 | Be applied to aseptic inspection's of medical instrument product device |
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