阅读说明：本技术 一种过氧化氢等离子体五类卡灭菌挑战装置及其制作方法 (hydrogen peroxide plasma five-class card sterilization challenge device and manufacturing method thereof ) 是由 邹辰明 张剑 于 2019-09-11 设计创作，主要内容包括：本发明公开了一种过氧化氢等离子体五类卡灭菌挑战装置及其制作方法,过氧化氢等离子体五类卡灭菌挑战装置由第五类化学指示物系统和管腔负载组成,所述的第五类化学指示物系统由化学指示卡、透明瓶、安装帽、安装胶圈和快速接头轴母头组成,所述的管腔负载由负载盒外壳、负载盒标签、快速接头轴公头、连接胶圈和两根聚四氟乙烯管组成,本发明的优点在于：实现了过氧化氢低温等离子体灭菌器灭菌结束后马上就能确定灭菌效果,并快速放行的问题,解决了困扰多年医疗领域天天都对管腔器械进行大量灭菌却无法进行快速放行的难题,实现了医疗人的梦想,为医院和患者规避了风险,给广大患者带来福音。(The invention discloses a hydrogen peroxide plasma five-type card sterilization challenge device and a manufacturing method thereof, wherein the hydrogen peroxide plasma five-type card sterilization challenge device consists of a fifth type chemical indicator system and a tube cavity load, the fifth type chemical indicator system consists of a chemical indicator card, a transparent bottle, an installation cap, an installation rubber ring and a quick joint shaft female head, and the tube cavity load consists of a load box shell, a load box label, a quick joint shaft male head, a connecting rubber ring and two polytetrafluoroethylene tubes, and the hydrogen peroxide plasma five-type card sterilization challenge device has the advantages that: the problem that the sterilization effect can be determined immediately after the hydrogen peroxide low-temperature plasma sterilizer finishes sterilization and the hydrogen peroxide low-temperature plasma sterilizer is released quickly is solved, the problem that a large amount of tubular cavity instruments are sterilized all day by day but the tubular cavity instruments cannot be released quickly in the medical field for many years is solved, the dream of medical workers is realized, risks are avoided for hospitals and patients, and good news is brought to patients.)

1. A hydrogen peroxide plasma five-type card sterilization challenge device is characterized in that: the tube cavity load comprises a load box shell, a load box label, a quick joint shaft male head, a connecting rubber ring and two polytetrafluoroethylene tubes, wherein the polytetrafluoroethylene tubes are 1-5 mm in inner diameter and 0.1-1 m in length, the quick joint shaft male head is spliced through the corresponding quick joint shaft female heads at the two ends of the fifth type chemical indicator system, and the sealing state is kept through the rubber ring between the quick joint shaft male head and the quick joint shaft female head, so that the fifth type chemical indicator system is connected with the polytetrafluoroethylene tubes in the tube cavity load and the sealing state is kept.

2. the method of claim 1, wherein the method comprises the steps of:

1) Preparing raw materials: weighing 5% of alkaline blue, 15% of ethyl acetate, 20% of isopropanol, 15% of ethanol, 20% of purified water, 8% of polypropylene, 2% of polyethylene glycol, 5% of copper sulfide, 5% of ferrous sulfide and 5% of copper sulfate according to mass percentage;

2) Preparing color-changing ink: mixing the raw materials prepared in the step 1), putting the mixture into a reaction kettle, and stirring the mixture for 30 minutes at normal temperature to prepare the color-changing ink;

3) printing: printing explanatory characters and color-changing ink according to a design drawing to manufacture a large-area semi-finished product;

4) cutting: cutting the printed large-area semi-finished product by using a die cutter manufactured according to a set shape to obtain a single semi-finished product;

5) drying: drying the semi-finished product obtained by cutting in the step 6) for 3 hours to obtain a single semi-finished product;

6) Assembling: clamping the chemical indicator into the transparent bottle, screwing down the mounting cap, and sealing the transparent bottle and the mounting cap by using a mounting rubber ring to prepare an independent fifth type chemical indicator system;

7) Packaging: and (4) hermetically packaging the independent fifth type chemical indicator system, and marking a production batch number, a production date and an expiration date, and packaging together with the lumen load.

8) Use of: after a customer obtains the hydrogen peroxide plasma five-type card sterilization challenge device, the validity period of the fifth-type chemical indicator system is checked, if the fifth-type chemical indicator system is correct, a sealed package of the fifth-type chemical indicator system is opened, the fifth-type chemical indicator system is connected with a tube cavity load and kept in a sealed state, the whole set of hydrogen peroxide plasma five-type card sterilization challenge device is placed into a sterilizer to be sterilized along with instruments, and after sterilization is finished, whether the sterilization qualified requirement is met or not is judged through the color of the chemical indicator card.

Technical Field

the invention relates to a hydrogen peroxide plasma five-type card sterilization challenge device and a manufacturing method thereof.

Background

with the birth of the first hydrogen peroxide low-temperature plasma sterilizer in China, the Chinese medical sterilization industry has revolutionized, and the hydrogen peroxide low-temperature plasma sterilizer is almost used for sterilizing advanced medical instruments in hospitals all over the country and all over the world. But new problems arise, as do the commonly used and expensive medical devices with very complex lumens, which are used on patients repeatedly every day, whether the sterilization effect is acceptable or not? Can the instrument be used immediately after sterilization? Can the sterilization be qualified? The evaluation is never carried out because the sterilization effect of the complex tube cavity cannot be detected and evaluated, which forms a quite embarrassing situation in the field of medical sterilization. Brings great risk to hospitals, namely postoperative infection, and also brings great life risk to patients. Infection accidents frequently occur to countries and common people in the past decade, causing great loss and pain.

disclosure of Invention

The invention aims to provide a hydrogen peroxide plasma five-class card sterilization challenge device, a fifth-class chemical indicator system contained in the device belongs to chemical indicators in packages, whether the sterilization is qualified is judged through color change, and lumen load is used for simulating the structure and the size of an instrument which is most difficult to sterilize so as to solve the risk that the basis of releasing the instrument in the current medical field is insufficient; addressing the risk of failing to comply with the chemical indicator mandated requirements within WS 310.3-20164.4.1.3 and 4.4.4.3.3 packages; the risk that the chemical monitoring representing the sterilization effect cannot be carried out on the position where the instruments are most difficult to sterilize is solved.

in order to solve the technical problems, the technical scheme provided by the invention is as follows: a hydrogen peroxide plasma five-class card sterilization challenge device is composed of a fifth-class chemical indicator system and a lumen load, wherein the fifth-class chemical indicator system is composed of a chemical indicator card, a transparent bottle, a mounting cap, a mounting rubber ring and a quick connector shaft female head, the lumen load is composed of a load box shell, a load box label, a quick connector shaft male head, a connecting rubber ring and two polytetrafluoroethylene tubes, the polytetrafluoroethylene tubes are 1-5 mm in inner diameter and 0.1-1 m in length, the quick connector shaft male heads are inserted and connected through the corresponding quick connector shaft female heads at two ends of the fifth-class chemical indicator system, and a sealing state is kept through the rubber ring between the quick connector shaft male heads and the quick connector shaft female heads, so that the fifth-class chemical indicator system is connected with the polytetrafluoroethylene tubes in the lumen load, and the sealing state is kept.

a manufacturing method of a hydrogen peroxide plasma five-type card sterilization challenge device comprises the following steps:

1) Preparing raw materials: weighing 5% of alkaline blue, 15% of ethyl acetate, 20% of isopropanol, 15% of ethanol, 20% of purified water, 8% of polypropylene, 2% of polyethylene glycol, 5% of copper sulfide, 5% of ferrous sulfide and 5% of copper sulfate according to mass percentage;

2) Preparing color-changing ink: mixing the raw materials prepared in the step 1), putting the mixture into a reaction kettle, and stirring the mixture for 30 minutes at normal temperature to prepare the color-changing ink;

3) Printing: printing explanatory characters and color-changing ink according to a design drawing to manufacture a large-area semi-finished product;

4) Cutting: cutting the printed large-area semi-finished product by using a die cutter manufactured according to a set shape to obtain a single semi-finished product;

5) Drying: drying the semi-finished product obtained by cutting in the step 6) for 3 hours to obtain a single semi-finished product;

6) Assembling: clamping the chemical indicator into the transparent bottle, screwing down the mounting cap, and sealing the transparent bottle and the mounting cap by using a mounting rubber ring to prepare an independent fifth type chemical indicator system;

7) packaging: and (4) hermetically packaging the independent fifth type chemical indicator system, and marking a production batch number, a production date and an expiration date, and packaging together with the lumen load.

8) Use of: after a customer obtains the hydrogen peroxide plasma five-type card sterilization challenge device, the validity period of the fifth-type chemical indicator system is checked, if the fifth-type chemical indicator system is correct, a sealed package of the fifth-type chemical indicator system is opened, the fifth-type chemical indicator system is connected with a tube cavity load and kept in a sealed state, the whole set of hydrogen peroxide plasma five-type card sterilization challenge device is placed into a sterilizer to be sterilized along with instruments, and after sterilization is finished, whether the sterilization qualified requirement is met or not is judged through the color of the chemical indicator card.

the invention has the advantages that: the characteristic of the fifth type of chemical indicator card determines that the color change of the chemical indicator card in the fifth type of chemical indicator system is qualified, which means that the sterilization qualified requirement is met, and the sterilization effect can be determined immediately after the hydrogen peroxide low-temperature plasma sterilizer finishes sterilization, and the sterilization effect is released quickly. The problem that a large amount of sterilization can not be performed on the cavity instruments every day but the cavity instruments can not be rapidly released in the medical field of many years is solved. Realizes the dream of medical people, avoids risks for hospitals and patients and brings good news to patients.

Drawings

fig. 1 is a schematic structural diagram of a hydrogen peroxide plasma five-type card sterilization challenge device.

FIG. 2 is a schematic diagram of a fifth class of chemical indicator systems in an open state.

FIG. 3 is a schematic diagram of a fifth class of chemical indicator systems in an installed state.

As shown in the figure: 1. load box label, 2, quick-operation joint axle public head, 3, fifth type chemical indicator system, 4, load box shell, 5, polytetrafluoroethylene pipe, 6, lumen load, 7, connect the rubber ring, 8, quick-operation joint axle female head, 9, installation cap, 10, chemical indicator card, 11, installation rubber ring, 12, transparent bottle, 13, rubber ring.

Detailed Description

The invention is illustrated below by means of specific examples, without restricting it.

As shown in fig. 1-3, a hydrogen peroxide plasma five-type card sterilization challenge device comprises a fifth-type chemical indicator system 3 and a lumen load 6, wherein the fifth-type chemical indicator system 3 comprises a chemical indicator card 10, a transparent bottle 12, a mounting cap 9, a mounting rubber ring 11 and a quick coupling shaft female head 8, the lumen load 6 comprises a load box shell 4, a load box label 1, a quick coupling shaft male head 2, a connecting rubber ring 7 and two polytetrafluoroethylene tubes 5, the polytetrafluoroethylene tubes 5 have the inner diameter of 1 mm-5 mm and the length of 0.1 m-1 m, the quick coupling shaft male heads 2 are inserted through the corresponding quick coupling shaft female heads 8 at two ends of the fifth-type chemical indicator system 3 and are kept in a sealing state through the rubber ring 13 between the two quick coupling shaft male heads, so that the fifth-type chemical indicator system 3 is connected with the polytetrafluoroethylene tubes 5 in the lumen load 6, and maintains a sealed state.

a manufacturing method of a hydrogen peroxide plasma five-type card sterilization challenge device comprises the following steps:

1) Preparing raw materials: weighing 5% of alkaline blue, 15% of ethyl acetate, 20% of isopropanol, 15% of ethanol, 20% of purified water, 8% of polypropylene, 2% of polyethylene glycol, 5% of copper sulfide, 5% of ferrous sulfide and 5% of copper sulfate according to mass percentage;

2) preparing color-changing ink: mixing the raw materials prepared in the step 1), putting the mixture into a reaction kettle, and stirring the mixture for 30 minutes at normal temperature to prepare the color-changing ink;

3) printing: printing explanatory characters and color-changing ink according to a design drawing to manufacture a large-area semi-finished product;

4) cutting: cutting the printed large-area semi-finished product by using a die cutter manufactured according to a set shape to obtain a single semi-finished product;

5) Drying: drying the semi-finished product obtained by cutting in the step 6) for 3 hours to obtain a single semi-finished product;

6) Assembling: the chemical indicator card 10 is put into a transparent bottle 12, the mounting cap 9 is screwed down, and the transparent bottle 12 and the mounting cap 9 are sealed by a mounting rubber ring 11 to prepare an independent fifth-class chemical indicator system 3;

7) packaging: the individual fifth type of chemical indicator system 3 is hermetically packaged with the production lot number, production date and expiration date designation made and packaged with the lumen load.

8) Use of: after a customer obtains the hydrogen peroxide plasma five-type card sterilization challenge device, the validity period of the fifth-type chemical indicator system 3 is checked, if the fifth-type chemical indicator system 3 is correct, a sealed package of the fifth-type chemical indicator system 3 is opened, the fifth-type chemical indicator system 3 is connected with the lumen load 6, the sealed state is kept, the whole set of hydrogen peroxide plasma five-type card sterilization challenge device is placed into a sterilizer to be sterilized along with instruments, and after sterilization is finished, whether the sterilization qualified requirement is met or not is judged according to the color of the chemical indicator card.

the invention has the advantages that: the characteristic of the fifth type of chemical indicator card determines that the color change of the chemical indicator card in the fifth type of chemical indicator system is qualified, which means that the sterilization qualified requirement is met, and the sterilization effect can be determined immediately after the hydrogen peroxide low-temperature plasma sterilizer finishes sterilization, and the sterilization effect is released quickly. The problem that a large amount of sterilization can not be performed on the cavity instruments every day but the cavity instruments can not be rapidly released in the medical field of many years is solved. Realizes the dream of medical people, avoids risks for hospitals and patients and brings good news to patients.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.