How to do airtightness and waterproof test for medical devices, using this one method is enough

Medical devices refer to all kinds of equipment, apparatus, instruments, materials and other related products used for medical diagnosis, treatment or prevention of diseases. Medical devices are widely used inmedical care,hygiene,health careand other areas, includingMedical imaging equipment, surgical instruments, medical electronic instruments, diagnostic reagents, artificial organs, drug delivery equipmentet al. (and other authors)The

How to do airtight waterproof test for medical devices, this one method is enough Illustration — *Medical devices are widely used in the fields of medicine, sanitation, health care, etc.*

Medical devices are used for a wide range of purposes, helping healthcare workers to improve the efficiency and quality of healthcare, as well as helping patients to regain their health and improve their quality of life. For example:

Diagnostic instruments:Such as sphygmomanometers, thermometers, electrocardiographs, X-ray machines, CT machines, MRI machines, and so on, are used to diagnose and assess the patient's condition.
Surgical Instruments:Such as scalpels, suture needles, electrocoagulators, suction devices, etc., used for surgical operations and treatments.
Therapeutic Instruments:Such as drug pumps, ventilators, infusion pumps, and rehabilitation trainers are used to treat a patient's illness or injury.
Monitoring instruments:Such as heart rate monitors, blood glucose meters, and respiratory rate monitors are used to monitor the patient's vital signs and changes in condition.
Rehabilitation equipment:Such as orthopedic devices, walking aids, prosthetic limbs, wheelchairs, etc., are used to help patients rehabilitate and restore their daily life functions.

The manufacturing process of medical devices usually requires aairtightness (also called watertightness) test.to ensure its normal use in the course ofNo leakage or failureand other issues, guaranteeing patient safety and treatment results.Medical devices that specifically require air tightness testing include, but are not limited to:

Infusion sets, drug pumps, syringes and other liquid delivery devices
Respiratory equipment such as endotracheal tubes, oxygen masks, etc.
Cardiac electrophysiology equipment such as pacemakers and defibrillators
Medical imaging and surgical equipment such as otorhinolaryngoscopes, endoscopes, surgical instruments, etc.

Test methods includePressure test (gas check),Vacuum testing (helium detection),Water tightness test (water test),Spray test (water test)etc., can be tested during the manufacturing process or before leaving the factory to ensure that the medical devices comply with the relevant safety standards and regulations.

Today we are focusing on pressure testing (gas checking), which is called the pressure drop method in the industry, and is usually done with aAir tightness testerConducted.

How to do airtight waterproof test for medical equipment, this one method is enough Illustration 1 — *Part of the medical device industry airtightness testing cases of Jingcheng Industrial Technology*

As the name suggests, the principle of pressure testing is: the medical device under test is enclosed in an airtight container, by increasing the pressure inside the chamber, after a period of time to observe whether there is any fluctuation in pressure to determine whether the product under test is leaking.

6. Positive & Negative Pressure test principle — Pressure drop method: The workpiece under test is filled with gas at a set pressure, and after inflation and equilibrium (i.e., the gas is filled with the workpiece and evenly distributed), the pressure drop value is detected for a certain time interval, and the leakage is calculated according to the gas equation of state whether the leakage amount is within the set range, so as to determine whether the workpiece is leaking or not.

utilizationAir tightness testerAll we need to do is to put the measured medical device samples into the fixture and directly call theAir Tightness Instrument ManufacturerThe factory-adjusted test program will automatically test when the instrument is started, making it easy and quick to get started.

Medical Dual Channelairtightness tester.Comparison of waterproofing performance of water tanks

How to do airtight waterproof test for medical devices, this one method is enough Illustration 3 — *Air test: After calling out the test program, the instrument will automatically test and judge the air tightness status of the product.*

How to do airtight waterproof test for medical devices, this one method is enough Illustration 4 — By observing the leakage value, when the product is tested for leakage, theairtightness meterThe screen displays the current NG sample leakage value; when the product is well sealed, the screen shows 0 or a very small leakage value at this time.

Isn't it very simple? This method avoids the watertightness test and spray test after measuring the product still need to dry, slow efficiency, cumbersome steps of the embarrassing situation.

How to do airtight waterproof test for medical devices, this one method is enough Illustration 5 — *Water Test: Rain Test Chamber*

Of course, in addition to gas and water tests, there are also vacuum tests, also known as helium tests, available on the marketHelium Leak DetectorIt can easily cost hundreds of thousands of dollars to build the equipment, but the downside is that theexpensive and more costly.One helium leak detector is enough to buy many.Air tightness tester......

How to do airtight waterproof test for medical devices, this one method is enough Illustration 6 — *Helium check:Helium Leak Detector*

Air tightness testerThe application program and technology on medical devices have been very mature, and gradually become theStandard for medical device manufacturers and automated production linesThe most important thing is that it has become the brightest star in the automated inspection equipment due to its high inspection efficiency and cost-effectiveness.