Air tightness test of the hottest medical products

2022-08-22
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Air tightness testing of medical products

in the past, medical products would use spot check immersion method to test whether the products were leaking. Immersion method has many inconveniences for testing, and it cannot be used for full inspection of production lines. In European countries, air tightness detectors have been used in large quantities to test medical products in batches

for leak detector equipment for air tightness detection, quality is very important. The annual output of a single medical product will be as high as several million pieces, and each product needs to be tested. The high service life and quality of the leak detector must be guaranteed, because the valve body inside the leak detector equipment needs to be replaced, and the circuit board continues to work

most instruments of medical products, such as trocar, filter, drip, catheter, blood device, aspirator, balloon, syringe, needle, injection tool, etc., need to be tested for waterproof grade. Due to the particularity of the medical industry, compressed air is generally used for testing, or in order to ensure cleanliness, dry nitrogen can be used for air tightness testing of leak detector. At present, waterproof testing in the medical industry is not popular enough, And it is not very standardized. The requirements of end customers for suppliers are also constantly improving, and the application of air tightness testing in the medical industry will continue to increase

the air tightness test of medical products must have the requirements of stability and missed detection rate:

for small-size medical instruments, we can use a single leak detector to test multiple workpieces. This method has fast test tempo and low cost of the test bench, which is suitable for the needs of mass production, but this method requires a relatively high qualified rate of products

when testing medical instruments such as infusion bags, a leak detector must correspond to a product test, and 8. Special tooling should be set after tightening the sample, because the volume of the infusion bag will expand after inflation, which will lead to the unreliability of the test

It can be used for prototype production

other types of medical product testing. We can refer to the test method of ST for European medical enterprises with the current market particle price of about 5000 ⑴ 2000 yuan per ton in forte, Italy. For example, for the test of catheter, we will give an inflation pressure of 0.3bar, and the leakage rate of the test product shall not exceed 0.2cc/min; For the kit, vacuum detection is required, and the leakage rate is 0.4cc/min; The leakage rate of tendon catheter shall not exceed 5cc/min; The flexible pipe needs low pressure, and its leakage rate is required to be 10cc/min; The leakage rate of plastic valve should also be 10cc/min; The above test parameters are only for reference, and the laboratory test parameters of different results, volume products and building materials testing will be different

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