CN113398305A - Process verification device for multipurpose ethylene oxide sterilization verification device - Google Patents
Process verification device for multipurpose ethylene oxide sterilization verification device Download PDFInfo
- Publication number
- CN113398305A CN113398305A CN202110700598.5A CN202110700598A CN113398305A CN 113398305 A CN113398305 A CN 113398305A CN 202110700598 A CN202110700598 A CN 202110700598A CN 113398305 A CN113398305 A CN 113398305A
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- Prior art keywords
- sterilization
- hollow tube
- verification device
- cabin body
- ethylene oxide
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- 230000001954 sterilising effect Effects 0.000 title claims abstract description 121
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 118
- 238000012795 verification Methods 0.000 title claims abstract description 29
- 238000000034 method Methods 0.000 title claims abstract description 25
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 title claims abstract description 20
- 239000000090 biomarker Substances 0.000 claims abstract description 33
- 239000000126 substance Substances 0.000 claims abstract description 32
- 230000035515 penetration Effects 0.000 claims abstract description 19
- 238000007789 sealing Methods 0.000 claims description 17
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical group FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 17
- 230000000149 penetrating effect Effects 0.000 description 14
- 238000012544 monitoring process Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Abstract
The invention relates to a process verification device of a multi-purpose ethylene oxide sterilization verification device, belonging to the technical field of low-temperature sterilization; the sterilization device comprises a sterilization cabin body used for loading chemical indicators and biological indicators, wherein one end of the sterilization cabin body is detachably sealed, and the other end of the sterilization cabin body is communicated with one end of a resistance hollow tube; the resistance hollow tube surrounds the periphery of the sterilization medium penetration part, and the other end of the resistance hollow tube is positioned inside the sterilization medium penetration part; the simulated lumen instrument can be used for simultaneously placing a chemical indicator and a biological indicator, and the sterilization effect of the lumen instrument or other instruments can be quickly and accurately judged through the color change of the chemical indicator and the culture result of the biological indicator; novel appearance and compact structure.
Description
Technical Field
The invention relates to a process verification device of a multi-purpose ethylene oxide sterilization verification device, belonging to the technical field of low-temperature sterilization.
Background
Ethylene oxide sterilization: a low-temperature sterilization mode for non-high-temperature resistant instruments used in hospitals.
Chemical indicators: and the sterilization device is used for a corresponding sterilization mode, and whether the sterilization effect is qualified or not is judged according to the color change condition of the chemical indicator.
The biological indicator is as follows: and (4) judging whether the sterilization effect is qualified or not according to the culture result of the biological indicator when the biological indicator is used for a corresponding sterilization mode.
The sterilization process verifying device comprises: means for establishing a defined resistance to the sterilization process for evaluating the performance of the sterilization process.
The medical instrument sterilization effect monitoring standard stipulates that representative PCD (sterilization process verification device) can be selected for monitoring the sterilization effect according to the type of the sterilized article to be loaded. The sterilization process verification device verifies the sterilization effect by simulating the most difficult sterilization state, thereby achieving the purpose of batch release.
The ethylene oxide can kill bacteria propagules and microorganisms such as spores, fungi, viruses and the like, and has the advantages of broad-spectrum sterilization, strong penetrating power, no damage to most of articles, quick volatilization after sterilization and the like, and particularly has more outstanding sterilization advantages to lumen instruments, the sterilization difficulty of the lumen instruments is greatly higher than that of medical instruments of common entities, the indicator in the bag can only monitor the surface sterilization effect of the instruments, the sterilization effect in the lumen is difficult to monitor, and therefore, the release of the verification device for the ethylene oxide sterilization process is imperative. The ethylene oxide sterilization verification device sold in the market can only be used for a chemical indicator card or a biological indicator, or can only be used once, which causes material waste.
At present, the existing ethylene oxide sterilization process verification device can only be used for placing one of a chemical indicator and a biological indicator, cannot be used for simultaneous monitoring, cannot accurately judge the sterilization effect only by placing the chemical indicator, and cannot be used for rapid monitoring only by placing the biological indicator.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the process verification device can be used for simulating the lumen instrument, placing a chemical indicator and a biological indicator, and quickly and accurately judging the sterilization effect of the lumen instrument or other instruments through the color change of the chemical indicator or the culture result of the biological indicator.
The invention discloses a process verification device of a multi-purpose ethylene oxide sterilization verification device, which comprises a sterilization cabin body used for loading chemical indicators and biological indicators, wherein one end of the sterilization cabin body is detachably sealed, and the other end of the sterilization cabin body is communicated with one end of a resistance hollow pipe; the resistance hollow tube surrounds the periphery of the sterilization medium penetrating part, and the other end of the resistance hollow tube is positioned inside the sterilization medium penetrating part.
The sterilizing chamber body is detachably sealed and is used for loading and unloading chemical indicators and biological indicators. The resistant hollow tube and the sterilization medium penetration portion have a portion with a certain resistance to the penetration of the sterilization medium to simulate the cavity apparatus. An independent sterilization cabin body is designed, so that chemical indicators and biological indicators can be conveniently placed at the same time.
When the sterilization chamber works, one end of the sterilization chamber body is opened, and the sterilization chamber body is sealed after being loaded with a chemical indicator and a biological indicator; the sterilization medium penetrates through the sterilization medium penetrating part, passes through the other end of the resistance hollow tube, follows the resistance hollow tube, and enters the sterilization cabin body through one end of the resistance hollow tube to contact with the chemical indicator and the biological indicator; the sterilization effect of the lumen instrument or other instruments can be judged quickly and accurately through the color change of the chemical indicator or the culture result of the biological indicator.
Preferably, the support shell comprises a cabin body support part, a hollow tube support part and a sterilization medium penetrating part, wherein the sterilization medium penetrating part is positioned in the hollow tube support part, and a penetrating part hole is formed in the sterilization medium penetrating part; one end of the sterilization cabin body penetrates through the cabin body supporting part and is sealed through a sealing plug; the resistance hollow tube surrounds the hollow tube support.
For connecting the parts into a whole.
Preferably, a sealing gasket is arranged between the sterilization chamber and the sealing plug.
Further improving the sealing effect.
Preferably, the resistant hollow tube is a tetrafluoroethylene hollow tube.
Further improving the resistance performance.
Preferably, the sterilization medium penetration portion has a rectangular shape with four rounded corners.
Novel appearance and compact structure.
Preferably, the other end of the sterilization cabin body is provided with an end head, and the end head is communicated with one end of the resistance hollow pipe through a connecting pipe.
Is used for communicating the other end of the sterilizing cabin body with one end of the resistance hollow tube.
Compared with the prior art, the invention has the following beneficial effects:
the process verification device of the multipurpose ethylene oxide sterilization verification device simulates the cavity apparatus, can be used for simultaneously placing a chemical indicator and a biological indicator, and can quickly and accurately judge the sterilization effect of the cavity apparatus or other apparatuses through the color change of the chemical indicator and the culture result of the biological indicator; novel appearance and compact structure.
Drawings
FIG. 1 is a schematic structural diagram of a process verification device of a multipurpose ethylene oxide sterilization verification device according to the present invention;
fig. 2 is a schematic view of the sealing plug of the present invention.
Wherein: 1. a sealing plug; 2. a sealing gasket; 3. sterilizing the cabin body; 4. a force-resistant hollow tube; 5. a sterilization medium penetration portion; 6. a support housing; 601. a cabin supporting part; 602. a hollow tube support; 603. a through hole; 7. a tip; 8. and (4) connecting the pipes.
Detailed Description
The invention is further described below with reference to the accompanying drawings:
example 1
As shown in fig. 1-2, the process verification device of the multipurpose ethylene oxide sterilization verification device of the invention comprises a sterilization chamber 3 for loading chemical indicators and biological indicators, wherein one end of the sterilization chamber 3 is detachably sealed, and the other end of the sterilization chamber 3 is communicated with one end of a resistance hollow tube 4; the resistance hollow tube 4 surrounds the periphery of the sterilization medium penetration part 5, and the other end of the resistance hollow tube 4 is positioned inside the sterilization medium penetration part 5.
The sterilization chamber 3 is detachably sealed and is used for loading and unloading chemical indicators and biological indicators. The resistant hollow tube 4 and the sterilization medium penetration portion 5 have a portion resistant to the penetration of the sterilization medium to simulate the lumen instrument. The independent sterilization chamber 3 is designed to facilitate the simultaneous placement of chemical indicators and biological indicators.
Here, the size of the sterilization chamber 3 is adapted to the specifications of the chemical indicator and the biological indicator, and different sizes can be designed according to the specifications of the chemical indicator and the biological indicator. A resistant hollow tube 4 is surrounded between one end and the other end and forms a resistant force through the tube body to simulate the cavity apparatus.
When the sterilization chamber works, one end of the sterilization chamber body 3 is opened, and the sterilization chamber body is sealed after being loaded with chemical indicators and biological indicators; the sterilization medium penetrates through the sterilization medium penetrating part 5, passes through the other end of the resistance hollow tube 4, follows the resistance hollow tube 4, and enters the sterilization cabin body 3 through one end of the resistance hollow tube 4 to contact with the chemical indicator and the biological indicator; the sterilization effect of the lumen instrument or other instruments can be judged quickly and accurately through the color change of the chemical indicator and the culture result of the biological indicator.
The support device further comprises a support shell 6, wherein the support shell 6 comprises a cabin body support part 601, a hollow tube support part 602 and a sterilization medium penetrating part 5, the sterilization medium penetrating part 5 is positioned in the hollow tube support part 602, and a penetrating hole 603 is formed in the sterilization medium penetrating part 5; one end of the sterilization cabin body 3 penetrates through the cabin body supporting part 601 and is sealed through the sealing plug 1; the resistant hollow tube 4 surrounds the hollow tube support 602.
For connecting the parts into a whole.
Wherein a sealing gasket 2 is arranged between the sterilization chamber body 3 and the sealing plug 1.
Further improving the sealing effect.
Wherein, the resistance hollow tube 4 is a tetrafluoroethylene hollow tube.
Further improving the resistance performance.
Wherein the sterilization medium penetration part 5 is a rectangle with smooth four corners.
Novel appearance and compact structure.
Wherein, the other end of the sterilization cabin body 3 is provided with an end head 7, and the end head 7 is communicated with one end of the resistance hollow tube 4 through a connecting tube 8.
Which is used for communicating the other end of the sterilization cabin body 3 with one end of the resistance hollow tube 4.
The invention discloses a process verification device of a multi-purpose ethylene oxide sterilization verification device, which comprises the following working processes:
opening one end of the sterilization cabin body 3, loading a chemical indicator and a biological indicator, and sealing by using a sealing plug 1; the sterilization medium penetrates through the sterilization medium penetrating part 5, passes through the other end of the resistance hollow tube 4, follows the resistance hollow tube 4, and enters the sterilization cabin body 3 through one end of the resistance hollow tube 4 to contact with the chemical indicator and the biological indicator; the sterilization effect of the lumen instrument or other instruments can be judged quickly and accurately through the color change of the chemical indicator and the culture result of the biological indicator.
In conclusion, the process verification device of the multipurpose ethylene oxide sterilization verification device simulates the cavity apparatus, can be used for simultaneously placing the chemical indicators and the biological indicators, and can quickly and accurately judge the sterilization effect of the cavity apparatus or other apparatuses through the color change of the chemical indicators and the culture result of the biological indicators; novel appearance and compact structure.
Claims (6)
1. The process verification device is characterized by comprising a sterilization cabin body (3) for loading chemical indicators and biological indicators, wherein one end of the sterilization cabin body (3) is provided with a detachable sealing plug (1), and the other end of the sterilization cabin body (3) is communicated with one end of a resistance hollow tube (4); the resistance hollow tube (4) surrounds the periphery of the sterilization medium penetration part (5), and the other end of the resistance hollow tube (4) is positioned inside the sterilization medium penetration part (5).
2. The multi-purpose ethylene oxide sterilization verification device process verification device according to claim 1, further comprising a support shell (6), wherein the support shell (6) comprises an upper layer and a lower layer, the upper layer and the lower layer are clamped by a buckle, each layer comprises a cabin body support part (601), a hollow tube support part (602) and a sterilization medium penetration part (5), the sterilization medium penetration part (5) is located in the hollow tube support part (602), and the sterilization medium penetration part (5) is provided with penetration holes (603); one end of the sterilization cabin body (3) penetrates through the cabin body supporting part (601) and is sealed by the sealing plug (1); the resistance hollow pipe (4) surrounds the periphery of the hollow pipe support part (602).
3. The multipurpose ethylene oxide sterilization verifier process verifier according to claim 2, wherein a sealing gasket (2) is disposed between the sterilization chamber (3) and the sealing plug (1).
4. The multi-purpose ethylene oxide sterilization verifier process verifier device of any one of claims 1-3, wherein the resistant hollow tube (4) is a tetrafluoroethylene hollow tube.
5. The multi-purpose ethylene oxide sterilization verifier process verifier device of claim 4, wherein the sterilization medium penetration portion (5) is formed with a penetration hole (603).
6. The multi-purpose ethylene oxide sterilization verifying attachment process verifying attachment of claim 4, characterized in that, the other end of the sterilization chamber body (3) is provided with a tip (7), the tip (7) is communicated with one end of the resistance hollow tube (4) through a connecting tube (8).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110700598.5A CN113398305A (en) | 2021-06-23 | 2021-06-23 | Process verification device for multipurpose ethylene oxide sterilization verification device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110700598.5A CN113398305A (en) | 2021-06-23 | 2021-06-23 | Process verification device for multipurpose ethylene oxide sterilization verification device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113398305A true CN113398305A (en) | 2021-09-17 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110700598.5A Pending CN113398305A (en) | 2021-06-23 | 2021-06-23 | Process verification device for multipurpose ethylene oxide sterilization verification device |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202184966U (en) * | 2011-07-20 | 2012-04-11 | 杭州泰林生物技术设备有限公司 | Challenge device for chemical gas sterilization |
| CN106267277A (en) * | 2016-09-28 | 2017-01-04 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator for monitoring lumen class apparatus sterilizing effect detects device |
| CN208229137U (en) * | 2017-05-23 | 2018-12-14 | 山东新华医疗器械股份有限公司 | A kind of chemistry verifying device applied to hydrogen peroxide low-temperature plasma sterilization process |
| CN211512788U (en) * | 2019-09-11 | 2020-09-18 | 衡水诺盾生物科技有限公司 | Hydrogen peroxide plasma body cavity biological sterilization verification device |
| CN216417891U (en) * | 2021-06-23 | 2022-05-03 | 山东新华医疗器械股份有限公司 | Process verification device for multipurpose ethylene oxide sterilization verification device |
-
2021
- 2021-06-23 CN CN202110700598.5A patent/CN113398305A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202184966U (en) * | 2011-07-20 | 2012-04-11 | 杭州泰林生物技术设备有限公司 | Challenge device for chemical gas sterilization |
| CN106267277A (en) * | 2016-09-28 | 2017-01-04 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator for monitoring lumen class apparatus sterilizing effect detects device |
| CN208229137U (en) * | 2017-05-23 | 2018-12-14 | 山东新华医疗器械股份有限公司 | A kind of chemistry verifying device applied to hydrogen peroxide low-temperature plasma sterilization process |
| CN211512788U (en) * | 2019-09-11 | 2020-09-18 | 衡水诺盾生物科技有限公司 | Hydrogen peroxide plasma body cavity biological sterilization verification device |
| CN216417891U (en) * | 2021-06-23 | 2022-05-03 | 山东新华医疗器械股份有限公司 | Process verification device for multipurpose ethylene oxide sterilization verification device |
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