Chemical indicator card for monitoring low-temperature steam formaldehyde sterilization

Abstract

The invention discloses a chemical indicator card for monitoring low-temperature steam formaldehyde sterilization, which belongs to the technical field of medical treatment and public health sterilization monitoring, and is composed of a Tyvek paper carrier and chemical indicator ink mixed by multiple chemicals, and the carrier has the length of 70.4 + / -1mm and the width of 8.8 + / -0.5 mm; the indicating ink can generate controllable color change according to the concentration, temperature and time of formaldehyde sterilization by adjusting the component proportion; the indicator card is matched with a semicircular loading box made of an ABS (Acrylonitrile Butadiene Styrene) material, a polytetrafluoroethylene tube with a specific size is arranged in the box, when the color is successfully changed, 0.9 ml of hydrogen peroxide is injected, and sterilization is carried out for 210 seconds, and when the color is failed, 0.6 ml of hydrogen peroxide is injected at the same temperature at the same time. The indicator card is simple in structure and convenient to use, adapts to PCD scenes, fills up related gaps in China, improves the sterilization monitoring accuracy and provides guarantee for sterilization of lumen type instruments.

Description

Technical Field

[0001] This invention relates to the field of medical and health sterilization monitoring devices, specifically a chemical indicator card for monitoring low-temperature steam formaldehyde sterilization. Background Technology

[0002] With the rapid development of medical and health services and the continuous improvement of medical technology, various precision instruments and equipment are being gradually promoted and applied. However, these devices generally cannot be sterilized at high temperatures. Furthermore, various slender tubes, multi-cavity electro-dynamic devices, electronic instruments, and precision optical instruments are already widely used in clinical practice. However, due to their insensitivity to heat and moisture, the sterilization medium cannot easily reach the deep parts of the tubes and cavities, resulting in long sterilization and media desorption times. Although many sterilization methods are currently used clinically, their sterilization effects are not entirely satisfactory, and at least have certain shortcomings.

[0003] Low-temperature steam formaldehyde sterilization is a method of sterilization where steam helps formaldehyde penetrate and kill microorganisms at low temperatures. It is a type of low-temperature sterilization method, particularly suitable for sterilizing heat-sensitive substances. Low-temperature formaldehyde gas sterilizers (LTSF) can handle an increasing number of instruments: various types of endoscopes (rigid and flexible types – arthroscopes, cystoscopes, laparoscopes, bronchoscopes, colonoscopes, gastroscopes, duodenoscopes, cholangioscopes, laryngoscopes, and nephroscopes, etc.) and all heat-sensitive instruments used in ophthalmic surgery, as well as most plastic products (syringes, spools, catheters, heat-transmitting cables), etc. Currently, after years of continuous improvement, LTSF is widely used in many countries and regions, including Sweden, Norway, Denmark, Finland, Russia, Germany, France, Portugal, Greece, Turkey, and the United Kingdom.

[0004] Formaldehyde (35%–40%) aqueous solution, or formalin, is readily available and inexpensive on the market. With the exchange and development of science and technology, there is reason to believe that low-temperature steam formaldehyde sterilization technology will be more widely used and play a greater role in the medical and health field.

[0005] Low-temperature formaldehyde gas sterilization has only recently begun to be used in hospitals in China, and the corresponding chemical indicator cards are even rarer and difficult to find on the market. Currently, only the Lushui brand low-temperature formaldehyde sterilization indicator cards and the Kangmingna brand formaldehyde indicator cards are available on the market. Both of these are ordinary indicator cards used in sterilization packs and cannot be used in PCD (Potentially Detected and Distributed) systems. To meet the requirements of formaldehyde PCD, there is an urgent need to develop a chemical indicator card for monitoring low-temperature steam formaldehyde sterilization that is compatible with PCD. Summary of the Invention

[0006] The purpose of this invention is to develop a chemical indicator card with a simple structure and easy-to-use function for monitoring low-temperature steam formaldehyde sterilization, which is suitable for PCD application scenarios and improves the accuracy and reliability of low-temperature steam formaldehyde sterilization monitoring.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A chemical indicator card for monitoring low-temperature steam formaldehyde sterilization, comprising a carrier and chemical indicator ink; The carrier is Tyvek paper, and the dimensions of the carrier are 70.4±1mm in length and 8.8±0.5mm in width. The appearance requirements of the carrier are smooth, clean and flat. The chemical indicator ink is a mixture of various chemicals. Based on the influence of formaldehyde concentration, temperature, and time on the chemical reaction rate, the chemical indicator ink achieves controllable chemical changes in reaction time and temperature by adjusting the proportion of each component, and produces obvious color changes during the formaldehyde sterilization process.

[0008] Furthermore, the chemical indicator card is equipped with a load cell, which is a semi-circular structure made of engineering plastic ABS. The dimensions of the load cell are 155±2mm in length, 128±2mm in width, and 18.5±2mm in height. The appearance of the load cell is required to be smooth, clean, flat, and burr-free.

[0009] Furthermore, a polytetrafluoroethylene (PTFE) tube is provided inside the load box. The PTFE tube has a length of 1000mm ± 5mm, an inner diameter of 1mm ± 0.2mm, and an outer diameter of 2mm ± 0.2mm.

[0010] Furthermore, the conditions for the successful color change of the chemical indicator card are: temperature 50°C, 0.9 ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210 s.

[0011] Furthermore, the conditions for the chemical indicator card to fail to change color are: temperature 50°C, 0.6 ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210 s.

[0012] The beneficial effects of this invention are as follows: 1. It fills the gap in my country's low-temperature steam formaldehyde sterilization chemical indicator cards for PCD, and makes up for the lack of a series of sterilization chemical indicator varieties for research and development enterprises.

[0013] 2. It provides a solid basis for the scientific management of sterilization in my country, ensures the sterilization of lumen-type instruments, and provides a safe, reliable, and convenient monitoring method for sterilization detection and control, thereby guaranteeing the thoroughness of sterilization. Attached Figure Description

[0014] Figure 1This is a schematic diagram of the overall structure of a chemical indicator card for monitoring low-temperature steam formaldehyde sterilization according to the present invention; Figure 2 This is a schematic diagram of the load cell structure. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0016] In the description of the embodiments of the present invention, it should be noted that if terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of the invention is in use, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, terms such as "first," "second," and "third" are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0017] Furthermore, the use of terms such as "horizontal," "vertical," and "sag" does not imply that the component must be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0018] In the description of the embodiments of the present invention, "multiple" means at least two.

[0019] In the description of the embodiments of the present invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific circumstances.

[0020] A chemical indicator card for monitoring low-temperature steam formaldehyde sterilization, comprising a carrier 100 and a chemical indicator ink 200; The carrier 100 is made of Tyvek paper. The dimensions of the carrier 100 are 70.4±1mm in length and 8.8±0.5mm in width. The appearance requirements of the carrier 100 are smooth, clean and flat. The chemical indicator ink 200 is a mixture of various chemicals. Based on the influence of formaldehyde concentration, temperature, time and other conditions on the reaction rate in the chemical reaction, the chemical indicator ink 200 adjusts the proportion between the components of the indicator ink to make it a chemical change that can be controlled by reaction time and temperature. It produces obvious color changes during the formaldehyde sterilization process, and the color change can be used to identify whether the item has been sterilized.

[0021] The load cell 300, which is compatible with the chemical indicator card, is a semi-circular structure made of engineering plastic ABS. The overall length of the load cell 300 is 155±2mm, the width is 128±2mm, and the height is 18.5±2mm. The appearance of the load cell 300 is required to be smooth, clean, flat, and burr-free. The load cell 300 contains a polytetrafluoroethylene tube 301, which has a length of 1000mm±5mm, an inner diameter of 1mm±0.2mm, and an outer diameter of 2mm±0.2mm.

[0022] The conditions for successful color change of this chemical indicator card are: temperature 50℃, 0.9ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210s; the conditions for failure to change color are: temperature 50℃, 0.6ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210s.

[0023] The following section provides a more detailed description of a chemical indicator card for monitoring low-temperature steam formaldehyde sterilization, based on specific structural parameters and usage conditions.

[0024] The core of the chemical indicator card of the present invention consists of Tyvek paper carrier and chemical indicator ink. The chemical indicator ink is coated on the surface of Tyvek paper carrier. The carrier is prepared strictly according to the dimensions of 70.4±1mm in length and 8.8±0.5mm in width. The appearance must meet the requirements of being smooth, clean and flat, without wrinkles, damage or other defects. Chemical indicator inks are made from a mixture of various chemicals. By precisely adjusting the proportions of each chemical component, the ink can produce controllable chemical changes based on conditions such as concentration, temperature, and time during the formaldehyde sterilization process, thus exhibiting a noticeable color change.

[0025] The load cell used with this chemical indicator card is a semi-circular structure made of engineering plastic ABS. The external dimensions of the load cell are 155±2mm in length, 128±2mm in width, and 18.5±2mm in height. After processing, the surface of the load cell must be smooth, clean, flat, and free of burrs to avoid scratching the indicator card. A polytetrafluoroethylene (PTFE) tube is fixedly installed inside the load cell. The PTFE tube has dimensions of 1000mm±5mm in length, 1mm±0.2mm in inner diameter, and 2mm±0.2mm in outer diameter to provide a suitable PCD operating environment for the chemical indicator card.

[0026] In actual clinical use, the chemical indicator card of this invention is placed in the aforementioned matching load box and enters the low-temperature steam formaldehyde sterilization process together with the load box. When the sterilization environment reaches the conditions of 50°C, 0.9ml of hydrogen peroxide is injected into the resistance meter, and the sterilization duration is 210s, the chemical indicator card shows a significant color change, indicating that the sterilization is qualified; when the sterilization environment is the conditions of 50°C, 0.6ml of hydrogen peroxide is injected into the resistance meter, and the sterilization duration is 210s, the chemical indicator card does not show a qualified color change, indicating that the sterilization has failed. Medical personnel can intuitively judge the sterilization effect based on the color change.

[0027] The chemical indicator card of this invention has a simple structure and is easy to use. It can be directly adapted to PCD application scenarios, solving the technical defects of existing indicator cards that can only be used for sterilization packages and cannot be adapted to PCD. This allows hospitals to have a more accurate monitoring rate and more reliable indication effect when using the chemical indicator card in clinical practice.

[0028] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A chemical indicator card for monitoring low temperature steam formaldehyde sterilization, characterized by: It consists of a carrier and chemical indicator ink; The carrier is Tyvek paper, and the dimensions of the carrier are 70.4±1mm in length and 8.8±0.5mm in width. The appearance requirements of the carrier are smooth, clean and flat. The chemical indicator ink is a mixture of various chemicals. Based on the influence of formaldehyde concentration, temperature, and time on the chemical reaction rate, the chemical indicator ink achieves controllable chemical changes in reaction time and temperature by adjusting the proportion of each component, and produces obvious color changes during the formaldehyde sterilization process.

2. The chemical indicator card for monitoring low-temperature steam formaldehyde sterilization according to claim 1, characterized in that, The chemical indicator card is equipped with a load cell, which is a semi-circular structure made of engineering plastic ABS. The dimensions of the load cell are 155±2mm in length, 128±2mm in width, and 18.5±2mm in height. The appearance of the load cell is required to be smooth, clean, flat, and burr-free.

3. The chemical indicator card for monitoring low-temperature steam formaldehyde sterilization according to claim 2, characterized in that, The load box is equipped with a polytetrafluoroethylene (PTFE) tube, which has a length of 1000mm ± 5mm, an inner diameter of 1mm ± 0.2mm, and an outer diameter of 2mm ± 0.2mm.

4. The chemical indicator card for monitoring low-temperature steam formaldehyde sterilization according to claim 1, characterized in that, The conditions for the successful color change of the chemical indicator card are: temperature 50℃, 0.9ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210s.

5. The chemical indicator card for monitoring low-temperature steam formaldehyde sterilization according to claim 1, characterized in that, The conditions for the chemical indicator card to fail to change color are: temperature 50℃, 0.6ml of hydrogen peroxide injected into the resistance meter, and sterilization time 210s.

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