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Breakthrough of hermetic testing difficulties of medical devices

For medical devices that directly or indirectly affect the human body, its sealing is particularly important. On the one hand, it is the requirement of the use environment and service life of the medical device. Good sealing is the premise of the normal work of the medical device in the liquid and corrosive environment, in order to protect the parts of the device from the invasion of liquid and gas. On the other hand, good sealing can avoid bacteria and dirt residues in medical devices, and reduce wound infection and virus transmission caused by equipment hygiene. Therefore, the sealing detector is widely used in medical devices, and the sealing detection is an important part in the production and manufacture of medical devices.


Product drawing of air tightness tester for Harris technology puncture device


Harris TechnologyMeasuredPuncture deviceProduct Photograph

As a seal testing expert and equipment R & D company, we have also conducted in-depth research on the seal testing of medical devices. We found that to achieve high-precision seal testing of medical devices, we need to solve the following two problems. One is to carry out non-destructive testing for medical devices, and the other is to solve the impact of complex modeling of medical devices on sealing testing.

Why nondestructive testing? This depends on the particularity of medical devices, such as the human body endoscope with a camera, in order to protect the lens from scraping and wear in the detection, which affects the imaging quality, and the sealing of medical devices is closely related to the safety of surgery. In order to avoid medical accidents caused by performance damage, medical devices need to carry out non-destructive sealing detection. In addition, the pressure of medical devices also needs to be taken into account. Once the pressure cannot be controlled in the detection, the device will be damaged.

Why is the complex modeling of medical devices a difficult problem? This refers to the modeling problems of the medical device itself, such as surgical puncture device, surgical knife handle, liquid composition analyzer, medical washing gun, infusion tube and urine bag, which are different in modeling and materials, and determine their easy to damage, easy to change, complex structure and other characteristics, which have become the problems of testing the sealing of medical devices. In the process of sealing, it is difficult to fix and small in size, which makes it impossible to accurately control the detection.


Harris TechnologyMedical washing gun sealing detector(direct detection)

In order to realize non-destructive testing and reduce the impact of device modeling on testing, Harris technology uses mold for indirect testing, or uses direct testing for medical devices with inflation port. Direct detection is to inflate the instrument directly and monitor the change of air pressure, while indirect detection requires the assistance of mold, which is generally used for medical devices without air filling port. Next, let's focus on indirect detection.


Water proof tester of herrens technology tooth washer(indirect detection)

Hiris technology is making a suitable mold and tooling for the instruments that need to be tested. Put the instruments into the mold. After the upper and lower molds are closed, a sealed testing space will be formed, which is conducive to the realization of high-precision sealing testing. The mold is not only used as the container of instrument testing, but also as the protection device in the testing. The mold can isolate the influence of the outside world on the instrument in the testing, and realize the non-destructive testing.


Water proof tester of herrens technology tooth washermould

After the tightness detector is started, the tooling will inflate the mold, and the change felt by the precision pressure sensor of the tightness detection equipment will be transmitted to the sealing detection system. Finally, the leakage value of the gas can be obtained through a series of calculations, and then the sealing performance and IP waterproof grade of the device can be detected according to the leakage value. In this process, the pressure sensor will strictly control the detection pressure and carry out non-destructive testing within the tolerance range of the instrument.

The above content is the application of hermetic detector of Harris technology in the medical industry. This instrument can detect the hermetic properties of mobile phones, auto parts, batteries, home appliances, smart wear and other products. It is favored by manufacturers because of its high detection accuracy, high efficiency and low cost.

All the above are original contents, and the copyright belongs to Harris technology. Reproduction, plagiarism and false original are strictly prohibited. Once found, the consequences are at your own risk.

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