Medical Device Altitude Testing

What is Altitude Testing?

Altitude testing is used to simulate the operation stored, or shipment at different altitudes for a product, and evaluate the potential negative physical or operational effects caused by the low pressure environment. Generally, the tests simulate the low air pressure when operating a product at high altitude locations or air-shipping conditions. When considering that products and packages that may be sensitive to low-pressure environments, altitude testing is intended to provide for the expected reduction in air pressure when the products are transported by air or road over areas of high altitude. Especially, sealed liquid containers or non-porous packages may be severely affected by high altitude environments.

It's also common to simulate the operation and shipping at altitudes below sea level. And tests to simulate the high pressures underwater are called pressure tests or intrusion protection tests. Similarly, tests at the very low pressures of outer space or near-earth space are usually called vacuum tests rather than altitude tests.

How to Do the Altitude Testing?

The simulated altitudes are usually fixed when performing the altitude testing, with a typical period at each simulated altitude ranging from 1-hour to 1-day. It is also necessary to simulate the ramp rates between two altitudes which may occur during the shipment. Altitude tests are sometimes performed simultaneously with other tests. For example, in order to better simulate a high altitude, altitude tests can be performed simultaneously with temperature tests. Alternatively, there is a lower-cost way to simulate the effect of the low-density air at high altitudes, high-temperature tests of air-cooled equipment are performed without any air pressure reduction.

Vibration testing is occasionally performed simultaneously with altitude testing.  For example, in order to simulate vibration that may cause abrasion of sealed packages containing sterile medical devices, it's critical to perform the combined altitude and vibration testing.

STEMart offers Altitude Testing Services to evaluate any potential negative physical or operational effects caused by the low pressure environment. Our extensive expertise in the Altitude Testing will help to ensure your medical device be transported, stored, or operated at high altitude functionality and safety.

STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have any additional questions about Medical Device Altitude Testing or would like to consult with the experts at STEMart, please feel free to contact us.