Leak Testing and Product Design
Things that affect the air leak testing of a device produced
One of the most useful innovations includes making new medical devices and fixing the old ones so they can perform better. You might be thinking that how hard it can be to improve an old medical device. But let me tell you one thing, it is "quite" hard because changing these devices affect the leak test.
The things that affect the leak test of a device
Considerable improvements in a medical device can affect the leak test. Some of them are specified below.
· Altering the shape of a device
Altering or changing the shape of an existing medical device will affect the leak test. The reason for this is its dimension. As you tend to change the shape of an existing medical device, you change its dimension. Change in dimension alters the part volume. For those of you who do not know, part volume is directly proportional to the leak rate.
A changed leak rate will also affect the previous standards of the device, and for new standards, and fixtures you would need to make a new program. Creating a new program is not easy as it seems and requires various tests and verified documentations.
So, the shape does matter and you need to know the basics for it.
· Replacing the material
As time passes, medical devices tend to wear out because of frequent usage. Due to this wearing-out, device testers may think of fixing the medical device by replacing its material.
Moreover, changing the material of a device will also cause it to change its temperature. And as leak testers are sensitive to temperatures, it would also affect the leak rate in an undesirable way.
· Changing the color of a medical device
Changing the color of a medical device can affect its heat-absorbing, transferring, and reflecting properties. All of these properties tend to affect the leak rate test. And to get a suitable leak rate, you must make another new program, which is not very easy to make.
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