Indication label for sterilization verification

By using a single-layer label body design, adhesive is not placed in the breathable area, but only in the adhesive area. This solves the problems of complex manufacturing and gaps in existing indicator labels, and simplifies the process, reduces costs, and improves breathability, thus ensuring the accuracy of sterilization monitoring.

CN224070860UActive Publication Date: 2026-04-03SHINVA MEDICAL INSTR CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-04-08
Publication Date
2026-04-03

AI Technical Summary

Technical Problem

Existing indicator labels used for sterilization validation consist of a double-layer structure, which is complex to manufacture, has high material costs, and gaps are prone to appear at the bonding point between the breathable membrane and the backing paper, affecting the sterilization monitoring effect.

Method used

The label body adopts a single-layer design, with no adhesive in the breathable area and adhesive only in the adhesive area. The breathable area is located in the center and the adhesive area is located on the outer perimeter. Tyvek paper material is used to simplify the process, reduce material costs, and avoid gaps.

Benefits of technology

The manufacturing process has been simplified, material costs have been reduced, air permeability has been improved, unwanted substances have been prevented from entering the gaps, and the accuracy and reliability of the monitoring process have been ensured.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses an indication label for sterilization verification, which comprises a label body, two surfaces of the label body are respectively an information surface and a connecting surface, the label body comprises a breathable area and a pasting area, only the connecting surface of the pasting area is provided with viscose, and the connecting surface of the breathable area is not provided with viscose. When the indication label is applied to the biological verification device, gas can enter the biological verification device more easily through the ventilation holes of the biological verification device through the ventilation area and cannot be affected by the adhesive when making contact with the adhesive, only single-layer manufacturing is needed, the manufacturing technological process can be simplified compared with an existing double-layer structure, and the manufacturing cost is reduced. And the material cost consumed by manufacturing is reduced, and the integrated structure enables no gap to appear, so that unnecessary substances can be prevented from entering from the gap, and the whole monitoring process is free from adverse effects.
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Description

Technical Field

[0001] This utility model relates to the field of biological monitoring equipment technology, and more specifically, to an indicator label for sterilization verification. Background Technology

[0002] In the medical field, aseptic assurance of medical devices is a fundamental requirement for patient health and safety. Sterilization biomonitoring is a highly reliable indicator for evaluating the sterilization effectiveness of medical tubular devices. Biovalidation devices are widely used in sterilization monitoring within the central sterile supply department. Hydrogen peroxide sterilization is an important sterilization method for high-temperature-intolerant and precision medical tubular devices. Indicator labels are typically used to verify whether the device has undergone sterilization. Specifically, the color-changing ink on the indicator label changes color upon contact with a specific sterilization medium. Furthermore, the indicator label can be used to record information about the biovalidation device and must be removable and affixed to a logbook after removal, facilitating the recording of information after the biovalidation device's sterilization.

[0003] A flexible sheet-like label is available for adhesion to sterilization validation devices (such as biological indicators). This label includes opposing adhesive and informational surfaces. The adhesive surfaces are sticky, allowing the label to adhere to the sterilization validation device. The informational surfaces contain chemical indicator marks and readable labeling information indicating the sterilization validation device to which the label is located. The chemical indicator marks are capable of changing appearance to indicate the sterilization effect of the device. At least a portion of the label is a detachable section, on which the chemical indicator marks and labeling information are located. This detachable section can be completely peeled off the sterilization validation device, and the side of the detachable section opposite to the chemical indicator marks and labeling information remains sticky at least after the detachable section is first peeled off the device. However, the existing indicator labels consist of two layers: a backing paper and a breathable film. Therefore, the manufacturing process is very complex, and the material cost of the double-layer structure is high. Moreover, gaps are easily formed at the bonding points between the breathable film and the backing paper due to improper bonding. This can cause unwanted substances to seep in through the gaps, which can have an adverse effect on the sterilization biomonitoring process. Utility Model Content

[0004] To address the aforementioned technical problems, this utility model provides an indicator label for sterilization verification, suitable for bioverification devices. It simplifies the manufacturing process, reduces material costs, and its integrated structure eliminates gaps, preventing unwanted substances from entering and protecting the entire monitoring process from adverse effects.

[0005] The present invention provides an indicator label for sterilization verification, comprising a label body, wherein the two sides of the label body are an information surface and a connection surface, the label body includes a breathable area and an adhesive area, only the connection surface of the adhesive area has adhesive, and the connection surface of the breathable area does not have adhesive.

[0006] Preferably, in the above-mentioned indicator label for sterilization verification, the breathable area is located in the central part of the label body, and the adhesive area is located in the outer periphery of the breathable area.

[0007] Preferably, in the above-mentioned indicator label for sterilization verification, adhesive is provided on at least two opposite sides of the adhesive area.

[0008] Preferably, in the above-mentioned indicator label for sterilization verification, all four sides of the adhesive area are provided with adhesive.

[0009] Preferably, in the above-mentioned indicator label for sterilization verification, the thickness of the breathable area is less than the thickness of the adhesive area.

[0010] Preferably, in the above-mentioned indicator label for sterilization verification, the thickness of the breathable zone ranges from 0.05 mm to 0.12 mm.

[0011] Preferably, in the above-mentioned indicator label for sterilization verification, the thickness of the adhesive area ranges from 0.15 mm to 0.25 mm.

[0012] Preferably, in the above-mentioned indicator label for sterilization verification, the label body is a Tyvek paper label.

[0013] Preferably, in the above-mentioned indicator label for sterilization verification, the information surface is provided with an information recording area and an indicator color-changing ink area.

[0014] Preferably, in the above-mentioned indicator label for sterilization verification, the information surface is further provided with a traceability code area.

[0015] As can be seen from the above technical solution, the indicator label for sterilization verification provided by this utility model includes a breathable area and an adhesive area. Only the connecting surface of the adhesive area has adhesive, while the connecting surface of the breathable area does not. Therefore, when applied to a bio-verification device, the breathable area allows gas to enter the interior more easily through the vent of the bio-verification device without being affected by the adhesive. Moreover, it only requires a single layer to manufacture, which simplifies the manufacturing process and reduces the material cost compared to the existing double-layer structure. Furthermore, the integrated structure prevents gaps, thus avoiding unwanted substances from entering through gaps and protecting the entire monitoring process from adverse effects. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0017] Figure 1 An information panel schematic diagram of an embodiment of an indicator label for sterilization verification provided by this utility model;

[0018] Figure 2 A schematic diagram of the connection surface of an embodiment of an indicator label for sterilization verification provided by this utility model. Detailed Implementation

[0019] The core of this invention is to provide an indicator label for sterilization verification, which is suitable for bio-verification devices. It simplifies the manufacturing process, reduces the material costs of manufacturing, and the integrated structure prevents gaps, thus preventing unwanted substances from entering through gaps and protecting the entire monitoring process from adverse effects.

[0020] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0021] An embodiment of the indicator label for sterilization verification provided by this utility model is as follows: Figure 1 and Figure 2 As shown, Figure 1 This is an information panel schematic diagram of an embodiment of an indicator label for sterilization verification provided by this utility model. Figure 2This is a schematic diagram of the connection surface of an embodiment of an indicator label for sterilization verification provided by this utility model. The indicator label for sterilization verification may include a label body 1, which is made of a single layer. The label body 1 has an information surface 11 and a connection surface 12 on its two sides. The information surface 1 is used to record various relevant information and is generally referred to as the front side. In use, the information surface 1 faces outwards. The connection surface 12 is used to connect the label body 1 to other objects, such as to a related bio-verification device, allowing the label body to stand for a certain period of time, allowing gas to enter the bio-verification device through the vent. It should be noted that this bio-verification device is a tool used to determine whether sterilization equipment is qualified. Its core is a bioindicator, which is a product of special live microorganisms that have definite and stable tolerance to a specific sterilization procedure. It is usually packaged in an inner layer and used to confirm the performance of sterilization equipment, verify sterilization procedures, and monitor the sterilization effect of the production process. The label body 1 may include a venting area 121 and an adhesive area 122. The venting area 121 is used to allow gas to pass through so that gas can enter the bio-verification device. Within the verification device, the adhesive area 122 is used to connect the label body 1 to the bioverification device. The label body 1 itself needs to be made of breathable material. Only the connecting surface 12 of the adhesive area 122 has adhesive, while the connecting surface 12 of the breathable area 121 does not. This ensures that gas can pass through the breathable area 121 without being obstructed by the adhesive, allowing for rapid and efficient gas permeation to achieve normal sterilization. Furthermore, the adhesive in the adhesive area ensures that the label body is temporarily and firmly bonded to the bioverification device. There should be no detachment, and the adhesive should be able to support re-attachment. At least after the first removal from the bio-verification device, it should still maintain its stickiness and structural integrity, and be able to be peeled off and pasted onto a notebook for easy recording and archiving. It is clear that the key point of this solution is that it no longer applies adhesive to the front of the connecting surface 12 as in existing technologies, but only applies adhesive to areas that are not used for ventilation, thereby improving ventilation efficiency. Moreover, the single-layer structure is easier to manufacture, reduces the cost of manufacturing materials, and avoids the problem of misalignment with the ventilation holes of the bio-verification device cap.

[0022] As can be seen from the above technical solution, in the embodiment of the indicator label for sterilization verification provided by this utility model, since the label body includes a breathable area and an adhesive area, only the connecting surface of the adhesive area has adhesive, while the connecting surface of the breathable area does not have adhesive. Therefore, when applied to a bio-verification device, the breathable area allows gas to enter the interior more easily through the vent of the bio-verification device without being affected by the adhesive. Moreover, it only requires a single layer to manufacture, which simplifies the manufacturing process and reduces the material cost compared to the existing double-layer structure. Furthermore, the integrated structure prevents gaps, thus avoiding unwanted substances from entering through gaps and protecting the entire monitoring process from adverse effects.

[0023] In one specific implementation of the indicator label used for sterilization validation described above, refer to... Figure 2 The venting area 121 is located in the center of the tag body 1, and the adhesive area 122 is located on the outer periphery of the venting area 121. In this case, when attaching the tag body 1, the venting area 121 in the center can be aligned with the vent on the bio-verification device so that gas can pass through this location and enter the bio-verification device. The adhesive on the adhesive area 122 is used to stably fix the outer periphery of the tag body 1 to the bio-verification device, preventing it from falling off during monitoring. It can be seen that by applying adhesive only to the peripheral area, the air intake in the center can be better prevented from being stuck by the adhesive. Moreover, attaching it to the periphery can make the overall force more even, preventing the problem of falling off from the edge. Of course, this is only a preferred solution, and other methods can be selected according to actual needs. There are no restrictions here.

[0024] In a further embodiment, adhesive is provided on at least two opposite sides of the aforementioned adhesive area 122. This includes three scenarios. The first scenario is that adhesive is provided only on the top and bottom horizontal edges, allowing the adhesive to extend across the entire label body from left to right. This allows the label body to be fixed to the biometric verification device using the adhesive on these two horizontal edges, ensuring a firm bond and preventing detachment. It also saves on adhesive usage, further reducing costs. Leaving a portion without adhesive also facilitates peeling off the label for recording, as it allows for easy access with a finger to the unadhesive area. After removing the label from the biometric verification device, the second option is to apply adhesive only to the left and right vertical edges, allowing the adhesive to run the entire length of the label. This ensures the label is firmly attached to the biometric verification device, preventing it from falling off, and also saves on adhesive usage, further reducing costs. The third option involves applying adhesive to all four edges of the adhesive area. This is suitable for situations requiring higher adhesion strength, but the adhesive cost will be higher. The choice can be made based on actual needs.

[0025] Based on the various embodiments of the indicator label for sterilization verification described above, the thickness of the breathable area 121 is preferably less than the thickness of the adhesive area 122. This thinner breathable area design allows the sterilization medium to more easily pass through the label body and enter the interior through the vent holes of the biovalidation device, further enhancing the breathability. In a further embodiment, the thickness of the breathable area 121 is preferably in the range of 0.05 mm to 0.12 mm, and can be further selected as 0.1 mm. These thicknesses allow for smoother airflow, thereby better ensuring the normal operation of the sterilization process. Moreover, the thickness of the adhesive area 122 is preferably in the range of 0.15 mm to 0.25 mm, and can be further selected as 0.20 mm. These thickness ranges ensure that the adhesive area 122 has sufficient overall mechanical strength, and the overall structure is more stable.

[0026] Furthermore, the aforementioned label body 1 can preferably be a Tyvek paper label. Tyvek paper is an existing material that combines the advantages of paper, film, and fabric. It is waterproof, breathable, strong, durable, lightweight, soft, and resistant to lint and shedding. Therefore, it can be used in this medical device field. Here, simply using Tyvek paper as the label achieves the functionality that existing technologies require two layers of materials, thus saving costs and simplifying the production process. Of course, this is only a preferred option; other existing materials can be selected according to actual needs, and there are no limitations here.

[0027] Continue to refer to Figure 1In a preferred embodiment of the above-described indicator label for sterilization verification, the information surface 11 may be provided with an information recording area 111 and an indicator color-changing ink area 112. The information recording area 111 may contain information such as name, model, batch number, production date and expiration date, which can be selected according to actual needs. The indicator color-changing ink area 112 may be provided with color-changing ink, which can indicate whether the bio-verification device has undergone a sterilization process.

[0028] In another preferred embodiment, reference continues to... Figure 1 The information surface 11 can also be set with a traceability code area 113, in which the traceability code can be a unique identifier of the biovalidation device, and the basic information of the biovalidation device is recorded in it. This makes it convenient to trace the indicator label and sterilization process later. Specifically, it can be in the form of a QR code. Of course, other types of codes, such as barcodes, can also be selected according to actual needs. There are no restrictions here.

[0029] In summary, the indicator label for sterilization verification provided in this application is a long strip-shaped indicator label formed by combining Tyvek backing paper with adhesive on the back. The information side is printed with indicator information and indicator color-changing ink, which facilitates the recording of sterilization information and whether the indicator has been used. After use, the label can be torn off and pasted into a logbook, making medical sterilization testing more convenient and faster.

[0030] The above description of the disclosed embodiments enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An indicator label for sterilization validation, characterized in that, The label body has two sides, an information side and a connecting side, and comprises a breathable area and a sticking area, only the connecting side of the sticking area has adhesive, and the connecting side of the breathable area is not provided with adhesive.

2. The indicator label for sterilization verification according to claim 1, characterized in that, The breathable area is located at the central part of the label body, and the sticking area is located at the outer peripheral part of the breathable area.

3. The indicator label for sterilization verification according to claim 2, characterized in that, At least two opposite sides of the sticking area are provided with adhesive.

4. The indicator label for sterilization verification according to claim 3, characterized in that, All four sides of the sticking area are provided with adhesive.

5. The indicator label for sterilization verification according to any one of claims 1 to 4, characterized in that, The thickness of the breathable area is less than the thickness of the sticking area.

6. The indicator label for sterilization verification according to claim 5, characterized in that, The thickness of the breathable area ranges from 0.05 mm to 0.12 mm.

7. The indicator label for sterilization verification according to claim 5, wherein, The thickness of the sticking area ranges from 0.15 mm to 0.25 mm.

8. The indicator label for sterilization verification according to claim 5, wherein, The label body is a Tyvek label.

9. The indicator label for sterilization verification according to any one of claims 1 to 4, characterized in that, The information side is provided with an information recording area and an indicating color-changing ink area.

10. The indicator label for sterilization verification according to claim 9, characterized in that, The information side is further provided with a traceability code area.