CN206473580U - Biological indicator detection means for monitoring lumen class apparatus sterilizing effect - Google Patents
Biological indicator detection means for monitoring lumen class apparatus sterilizing effect Download PDFInfo
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- CN206473580U CN206473580U CN201621085500.0U CN201621085500U CN206473580U CN 206473580 U CN206473580 U CN 206473580U CN 201621085500 U CN201621085500 U CN 201621085500U CN 206473580 U CN206473580 U CN 206473580U
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- tube chamber
- helical form
- form tube
- biological indicator
- class apparatus
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Abstract
The utility model discloses a kind of biological indicator detection means for monitoring lumen class apparatus sterilizing effect, including：Micropore length is away from helical form tube chamber lid, linker and microbial administration cavity；The micropore length is away from helical form tube chamber passage is provided with helical form tube chamber lid, the micropore length is covered away from helical form tube chamber is provided with the first air admission hole, the second air admission hole and venthole；Connected on the venthole in the linker, the microbial administration cavity and be provided with software seal rubber plug, degerming filter membrane, culture medium bag and microbial administration agent carrier.The utility model is used to simulate tube chamber class apparatus, the real work length of its helical form tube chamber passage can be adjusted, make tube chamber channel design and tube chamber class apparatus subject to sterilization closer to, the reliability of sterilizing testing result can be improved, and the utility model can be prevented effectively from the microorganisms such as the bacterium of outside and enter microbial administration cavity, interference detection results, it is the utility model small volume, easy to use, it has highly application value.
Description
Technical field
The utility model is related to biological sterilization detection technique field, especially a kind of to be used for monitoring lumen class apparatus sterilizing effect
The biological indicator detection means of fruit.
Background technology
Medicine equipment is the staple product of relation people's health, and safety and effectiveness is its most basic attribute, and sterile, is
The most basic measurement index that Safe of Medical Device is evaluated.In order to confirm whether sterilization process gets a desired effect, send out so far
Put on display a variety of sterilizing monitoring technology, including physical monitoring, chemical monitoring and biological monitoring.
Wherein physical monitoring to physical parameters such as time, temperature, concentration by measuring, for confirming that sterilization process is transported
Whether row state meets sets requirement.Chemical monitoring is the single or multi-parameter that sterilization process is monitored by color change, and then
Reflection is sterilized the sterilization process whether implements undergo setting.
Biology prison uses strong stress resistance in the gemma of general microorganism as indicator strain, and the quantity and drag of gemma are all remote
More than actual biological load (article subject to sterilization), by observing the killing situation of gemma, inferring the sterilizing of actual biological load has
Effect property.In addition, biological monitoring can be additionally used in sterilizing installation confirming performance, sterilization process checking, system suitability experiment and change
The links such as control.
Medicine equipment can be divided into height, moderate and low degree of hazard equipment according to risk of infection degree when in use, and to it
Microorganism residual proposes different require after sterilizing.Wherein, the use of tube chamber class apparatus is contacted with blood of human body and sterile tissue, is led to
Often there are attractor, laparoscope, rigid endoscope and soft scope etc., it, which sterilizes, requires more strict.Simultaneously as its structure is special
Property, the length of tube chamber is typically larger than many times of its diameter, and complicated construction is difficult to make bactericidal agent be perforated through tube chamber, causes sterilizing
It is required that higher, sterilizing validity is more difficult to reach.
In the past, it is common practice that biological indicator and chemical indicator are positioned in Packs sterilized, this method was only capable of generation
The Sterilization of table tube chamber apparatus outer surface, it is impossible to be used in the sterilization effect inside judging.
Recently, many unit simulation tube chamber apparatuses are have developed, for evaluating sterilization effect.Such as Patent No.
CN101698109A sterilization detection device, discloses a kind of detection means for simulating tube chamber class apparatus, wherein can inside device
Biological or chemical indicant is placed, after sterilizing, indicant is taken out, reflects that tube chamber class apparatus sterilizing is imitated by observing indicant
Really；A kind of Challenge device for chemical gas sterilization (Patent No.：CN202184966U), a kind of chemical gas sterilizing challenge is disclosed
Device, by placing biological indicator or chemical indicator, confirm chemical sterilization gas penetrates effect, and evaluating chemical gas goes out
The reliability of bacterium technique.
Its structure is fixed after existing tube chamber apparatus analogue means makes, it is impossible to according to the length of tube chamber apparatus subject to sterilization
And corresponding adjustment is made, easily decline the degree of accuracy of testing result.And present self-contained biological sterile indicator, sterilizing is subsequently
Peace a word used in place name bottle is crushed, allows nutrient solution to immerse in strain, wherein, broken peace a word used in place name bottle glass fragment is trapped in blake bottle and can influenceed
Light path stroke, influences the judgement of testing result.And present tube chamber apparatus analogue means also generally existing is easily by outside contamination, behaviour
Make the defects such as cumbersome, device is fragile.
Utility model content
Technical problem to be solved in the utility model is there is provided one kind to be used for for above-mentioned deficiency of the prior art
The biological indicator detection means of monitoring lumen class apparatus sterilizing effect.
In order to solve the above technical problems, the technical solution adopted in the utility model is：One kind is used for monitoring lumen class apparatus
The biological indicator detection means of sterilization effect, including：Micropore length is away from helical form tube chamber lid, linker and microbial administration cavity；
The micropore length is away from helical form tube chamber passage is provided with helical form tube chamber lid, the micropore length is away from helical form tube chamber
The first air admission hole connected with the helical form tube chamber passage is provided with cap upper surface, the micropore length is away from helical form tube chamber lid
The second air admission hole connected with the helical form tube chamber passage is provided with side, the micropore length is away from helical form tube chamber lid bottom
It is provided with the venthole connected with the helical form tube chamber passage；The linker is connected on the venthole；
The top of the microbial administration cavity is connected with bottom fitted seal of the micropore length away from helical form tube chamber lid, institute
The top for stating microbial administration cavity is provided with openend, the openend and is equipped with software seal rubber plug, the software
Degerming filter membrane and culture medium bag are disposed with below seal rubber plug, the microbial administration cavity bottom is provided with biological indicator
Carrier.
Preferably, second air admission hole at least includes 2, along the Vertical Square of the micropore length away from helical form tube chamber lid
Upward uniform intervals are set.
Preferably, first air admission hole is internally provided with inside the first degerming filtering layer, second air admission hole and set
There is the second degerming filtering layer.
Preferably, it is equipped with sealing stopple on first air admission hole and the second air admission hole.
Preferably, the linker has tip-like, is made of stainless steel material, for piercing through the software sealing
Plug, degerming filter membrane and culture medium bag.
Preferably, thalline is provided with the microbial administration agent carrier, the biological indicator carrier surface scribbles viscous
Property material, with effectively fix thalline.
Preferably, the micropore length is integrally formed away from helical form tube chamber lid by polytetrafluoroethylmaterial material by compression moulding.
Preferably, the microbial administration cavity is made from polystyrene material.
Preferably, the software seal rubber plug and sealing stopple are made from silica gel material.
Preferably, the degerming filter membrane, the first degerming filtering layer and the second degerming filtering layer are by polytetrafluoroethylmaterial material system
Into.
The utility model at least includes following beneficial effect：
1. the utility model is used to simulate tube chamber class apparatus, the utility model is by setting the first air admission hole and the second air inlet
Mouthful the real work length of helical form tube chamber passage is adjusted, so that according to the length adjustment spiral of tube chamber class apparatus subject to sterilization
The real work length of shape tube chamber passage, makes tube chamber channel design with tube chamber class apparatus subject to sterilization more closely, so as to improve
The reliability for the testing result that sterilizes.
2. the utility model is provided with degerming filter membrane, the first degerming filtering layer and the second degerming filtering layer, using preceding equipped with biology
The microbial administration cavity and external environment of indicator thalline, by pressing micropore length away from helical form tube chamber lid when using, make connection
Device penetrates seal rubber plug, can be prevented effectively from the microorganisms such as the bacterium of outside and enter microbial administration cavity, interference detection results.
3. the utility model is provided with culture medium bag in microbial administration cavity, after sterilizing by press again micropore length away from
Helical form tube chamber lid, makes linker penetrate culture medium bag, discharges liquid medium to cultivate thalline, detects sterilization effect, biology refers to
Show cavity all the time with external environment, the pollution using process external environment condition is avoided that, so as to effective evaluation sterilization effect.
4. it is the utility model small volume, easy to use, simple to operate, it has highly application value.
Brief description of the drawings
Fig. 1 is structural representation of the present utility model
Description of reference numerals：
1-micropore length is away from helical form tube chamber lid；11-sealing stopple；12-the first degerming filtering layer；13-the first air admission hole；
14-helical form tube chamber passage；15-the second degerming filtering layer；16-the second air admission hole；17-linker；18-venthole；2—
Microbial administration cavity；21-software seal rubber plug；22-degerming filter membrane；23-culture medium bag；24-microbial administration agent carrier.
Embodiment
The utility model is described in further detail below in conjunction with the accompanying drawings, to make those skilled in the art with reference to explanation
Book word can be implemented according to this.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein do not allot one or many
The presence or addition of individual other elements or its combination.
As shown in figure 1, a kind of biological indicator for monitoring lumen class apparatus sterilizing effect of the present embodiment detects dress
Put, including：Micropore length is away from helical form tube chamber lid 1, linker 17 and microbial administration cavity 2；
Micropore length is away from helical form tube chamber passage 14 is provided with helical form tube chamber lid 1, micropore length is away from helical form tube chamber lid 1
The first air admission hole 13 connected with helical form tube chamber passage 14 is provided with surface, micropore length is away from the side of helical form tube chamber lid 1
Be provided with the second air admission hole 16 connected with helical form tube chamber passage 14, micropore length away from the bottom of helical form tube chamber lid 1 be provided with
The venthole 18 that helical form tube chamber passage 14 is connected；Device 17 is connected on venthole 18,
Wherein, the second air admission hole 16 includes 2, the uniform intervals along in vertical direction of the micropore length away from helical form tube chamber lid 1
Set.First air admission hole 13 is internally provided with the first degerming filtering layer 12, and the second air admission hole 16 is internally provided with the second degerming filtering layer
15.Sealing stopple 11 is equipped with first air admission hole 13 and the second air admission hole 16.
Wherein, the sterilizing factor (such as ethylene oxide gas, steam etc.), can only pass through, lumen diameter is via spiral tube chamber
1mm-3mm, lumen length 20-150mm.
The utility model is used for simulating the sterilization process of tube chamber class apparatus, and it is entered simultaneously with tube chamber class apparatus subject to sterilization
Row sterilizing, is judged by detecting the sterilizing situation of the strain in microbial administration cavity 2 of the present utility model with batch tube chamber class device
The sterilization effect of tool.Because the length of tube chamber class apparatus subject to sterilization differs, then need to micropore length of the present utility model away from spiral shell
The length of helical form tube chamber passage 14 in rotation shape tube chamber lid 1 is also adjusted accordingly, and can just make helical form of the present utility model
The structure of tube chamber passage 14 is with tube chamber class apparatus subject to sterilization more closely, so that sterilizing testing result is relatively reliable.And this
Utility model is disposable, to improve the accuracy of testing result.
The utility model is by setting the first air admission hole 13 and the second air inlet to adjust the reality of helical form tube chamber passage 14
Border active length, specifically：
When extracting the sealing stopple 11 in the sealing stopple 11 in the first air admission hole 13, beyond the Great Wall the second air admission hole 16, go out
Bacteria factor enters helical form tube chamber passage 14 by the first air admission hole 13, and the real work length of helical form tube chamber passage 14 is first
Air admission hole 13 arrives whole length of venthole 18, and now its actual active length is most long；
When extracting the sealing stopple 11 in the sealing stopple 11 in the second air admission hole 16, beyond the Great Wall the first air admission hole 13, spiral shell
The length that the real work length of shape tube chamber passage 14 arrives venthole 18 for the second air admission hole 16 is revolved, now its actual active length
Less than the total length of helical form tube chamber passage 14, and the second air admission hole 16 includes along micropore length away from the vertical of helical form tube chamber lid 1
Uniform intervals are set on direction at least two, the real work length of helical form tube chamber passage 14 as needed selects it
In second air admission hole 16 as the air inlet port of the sterilizing factor, other air admission holes are filled in supporting sealing stopple 11
On.
The top of microbial administration cavity 2 is connected with bottom fitted seal of the micropore length away from helical form tube chamber lid 1, microbial administration
The top of cavity 2, which is provided with openend, openend, is equipped with software seal rubber plug 21, the lower section of software seal rubber plug 21 according to
Secondary to be provided with degerming filter membrane 22 and culture medium bag 23, the bottom of microbial administration cavity 2 is provided with microbial administration agent carrier 24, culture medium
It is equipped with bag 23 on liquid medium, microbial administration agent carrier 24 and strain is housed.
When in use, first appropriate pressing micropore length, away from helical form tube chamber lid 1, makes linker 17 penetrate seal rubber plug but not wear
Saturating degerming filter membrane 22, the first air admission hole 13 or the of the present utility model is selected according to the physical length of tube chamber class apparatus subject to sterilization
An air inlet port as the sterilizing factor in two air admission holes 16, it is long with the real work for adjusting helical form tube chamber passage 14
Degree, make its length with tube chamber class apparatus more closely, other air admission holes with supporting sealing stopple 11 beyond the Great Wall；Again by this reality
Sterilization treatment is carried out with new be together placed in ethylene oxide sterilizer with tube chamber class apparatus subject to sterilization, sterilizing parameter is：Temperature
Spend for 50 DEG C, relative humidity is 40%~65%, ethylene oxide gas bulk concentration is 650mg/L, action time is 2 hours.Again will
The utility model takes out, and pressing micropore length makes linker 17 penetrate culture medium bag 23 away from helical form tube chamber lid 1, discharges culture medium
Liquid medium in bag 23, makes liquid medium be mixed with the thalline on microbial administration agent carrier 24, is cultivated 7 days at 37 DEG C, root
Confirm whether ethylene oxide sterilizing effect reaches requirement according to cultivation results, so as to judge the sterilization effect of this batch of tube chamber class apparatus.
Wherein, degerming filter membrane 22, the first degerming filtering layer 15 of degerming filtering layer 12 and second use 0.22um polytetrafluoroethyl-ne
Alkene hydrophobic membrane is made.Degerming filter membrane 22, the first degerming filtering layer 15 of degerming filtering layer 12 and second can prevent the microorganisms such as outside bacterium
Into microbial administration cavity 2, interference detection results.
Wherein, linker 17 has tip-like, is made of stainless steel material, for piercing through software seal rubber plug 21, removing
Bacterium filter membrane 22 and culture medium bag 23.
Wherein, the thalline after air-drying processing is provided with microbial administration agent carrier 24, thalline is bacillus subtilis
(ATCC9372) gemma, the surface of microbial administration agent carrier 24 scribbles cohesive material, effectively to fix thalline.
Wherein, micropore length is integrally formed away from helical form tube chamber lid 1 by polytetrafluoroethylmaterial material by compression moulding.
Wherein, microbial administration cavity 2 is made from polystyrene material, and its internal diameter is 8mm, and wall thickness is 0.5mm.
Wherein, software seal rubber plug 21 and sealing stopple 11 are made from silica gel material.
In description of the present utility model, it is to be understood that term " " center ", " longitudinal direction ", " transverse direction ", " length ", " width
Degree ", " thickness ", " on ", " under ", "front", "rear", "left", "right", " vertical ", " level ", " top ", " bottom " " interior ", " outer ", " suitable
The orientation or position relationship of the instruction such as hour hands ", " counterclockwise ", " axial direction ", " radial direction ", " circumference " are based on orientation shown in the drawings
Or position relationship, be for only for ease of description the utility model and simplify and describe, rather than indicate or imply signified device or
Element must have specific orientation, with specific azimuth configuration and operation, therefore it is not intended that to limit of the present utility model
System.
Although embodiment of the present utility model is disclosed as above, it is not restricted in specification and embodiment
It is listed to use.It can be applied to various suitable fields of the present utility model completely.For those skilled in the art,
Other modification is easily achieved.Therefore under the universal limited without departing substantially from claim and equivalency range, this reality
Specific details is not limited to new and shown here as the legend with description.
Claims (10)
1. a kind of biological indicator detection means for monitoring lumen class apparatus sterilizing effect, it is characterised in that including：Micropore
Length is away from helical form tube chamber lid, linker and microbial administration cavity；
The micropore length is covered away from helical form tube chamber passage, the micropore length is provided with helical form tube chamber lid away from helical form tube chamber
The first air admission hole connected with the helical form tube chamber passage is provided with surface, the micropore length is away from helical form tube chamber lid side
On be provided with the second air admission hole connected with the helical form tube chamber passage, the micropore length is set away from helical form tube chamber lid bottom
There is the venthole connected with the helical form tube chamber passage；The linker is connected on the venthole；
The top of the microbial administration cavity is connected with bottom fitted seal of the micropore length away from helical form tube chamber lid, the life
Thing indicates that the top of cavity is provided with openend, the openend and is equipped with software seal rubber plug, and the software is sealed
Degerming filter membrane and culture medium bag are disposed with below plug, the microbial administration cavity bottom is provided with biological indicator load
Body.
2. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, second air admission hole at least includes 2, it is uniform along in the vertical direction of the micropore length away from helical form tube chamber lid between
Every setting.
3. the biological indicator detection means according to claim 2 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, first air admission hole is internally provided with the first degerming filtering layer, and it is degerming that second air admission hole is internally provided with second
Filtering layer.
4. the biological indicator detection means according to claim 2 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, sealing stopple is equipped with first air admission hole and the second air admission hole.
5. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, the linker is tip-like, is made from stainless steel material, for piercing through the software seal rubber plug, degerming filter
Film and culture medium bag.
6. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, thalline is provided with the microbial administration agent carrier, the biological indicator carrier surface scribbles cohesive material, with solid
Determine thalline.
7. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, the micropore length is made up away from helical form tube chamber lid of polytetrafluoroethylene (PTFE).
8. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, the microbial administration cavity is made from polystyrene material.
9. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, the software seal rubber plug and sealing stopple are made from silica gel material.
10. the biological indicator detection means according to claim 1 for monitoring lumen class apparatus sterilizing effect, it is special
Levy and be, the degerming filter membrane, the first degerming filtering layer and the second degerming filtering layer are made by polytetrafluoroethylmaterial material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201621085500.0U CN206473580U (en) | 2016-09-28 | 2016-09-28 | Biological indicator detection means for monitoring lumen class apparatus sterilizing effect |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201621085500.0U CN206473580U (en) | 2016-09-28 | 2016-09-28 | Biological indicator detection means for monitoring lumen class apparatus sterilizing effect |
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| Publication Number | Publication Date |
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| CN206473580U true CN206473580U (en) | 2017-09-08 |
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| CN201621085500.0U Active CN206473580U (en) | 2016-09-28 | 2016-09-28 | Biological indicator detection means for monitoring lumen class apparatus sterilizing effect |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110862920A (en) * | 2019-12-02 | 2020-03-06 | 吴权辉 | Container for biological indicator |
| US10907126B2 (en) | 2016-03-01 | 2021-02-02 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| US11053534B2 (en) | 2017-06-30 | 2021-07-06 | Asp Global Manufacturing Gmbh | Systems and methods for confirming activation of biological indicators |
| US11242505B2 (en) | 2017-01-03 | 2022-02-08 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| US11248250B2 (en) | 2017-12-01 | 2022-02-15 | Asp Global Manufacturing Gmb | Self-contained biological indicator |
| US11795044B2 (en) | 2020-11-10 | 2023-10-24 | Advanced Sterilization Products, Inc. | Ampoule breaker for a biological indicator |
| US11965151B2 (en) | 2021-01-22 | 2024-04-23 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
-
2016
- 2016-09-28 CN CN201621085500.0U patent/CN206473580U/en active Active
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10907126B2 (en) | 2016-03-01 | 2021-02-02 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| US11242505B2 (en) | 2017-01-03 | 2022-02-08 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
| US11053534B2 (en) | 2017-06-30 | 2021-07-06 | Asp Global Manufacturing Gmbh | Systems and methods for confirming activation of biological indicators |
| US11248250B2 (en) | 2017-12-01 | 2022-02-15 | Asp Global Manufacturing Gmb | Self-contained biological indicator |
| CN110862920A (en) * | 2019-12-02 | 2020-03-06 | 吴权辉 | Container for biological indicator |
| US11795044B2 (en) | 2020-11-10 | 2023-10-24 | Advanced Sterilization Products, Inc. | Ampoule breaker for a biological indicator |
| US11965151B2 (en) | 2021-01-22 | 2024-04-23 | Asp Global Manufacturing Gmbh | Self-contained biological indicator |
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