Comprehensive Altitude Testing for Medical Devices

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Comprehensive Altitude Testing for Medical Devices

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the expansion of its services to include comprehensive Altitude Testing. This new offering will help medical device manufacturers ensure the safety and efficacy of their products under extreme altitude conditions.

Altitude testing is used to simulate the storage or transport of a product at different altitudes and to assess the possible adverse physical or operational effects of a low pressure environment. In general, the tests simulate the low air pressure of a product operating at high altitude or under air transport conditions. Given that products and packaging may be sensitive to low pressure environments, the purpose of high altitude testing is to provide an indication of the reduction in air pressure that would be expected when a product is transported by air or ground at high altitude. In particular, hermetically sealed liquid containers or non-porous packaging can be severely affected by high altitude environments.

When performing altitude tests, the simulated heights are usually fixed, with typical times ranging from 1 hour to 1 day for each simulated height. It is also necessary to simulate the gradient between two heights that may occur during transport. Altitude tests are sometimes carried out in conjunction with other tests. For example, to better simulate high altitude, an altitude test may be performed in conjunction with a temperature test. Alternatively, a less expensive way to simulate the effects of low density air at high altitude is to perform a high temperature test on air cooled equipment without reducing the air pressure.

In addition, vibration testing is sometimes carried out in conjunction with high altitude testing. For example, to simulate the vibration that can cause wear on sealed packages containing sterile medical devices, altitude and vibration testing must be performed simultaneously.

To support medical device manufacturers in meeting regulatory objectives and ensuring the safety of their medical devices, STEMart offers comprehensive Altitude Testing Services to assess any adverse physical or operational effects that may result from low pressure environments. With extensive expertise in high altitude testing, STEMart can help manufacturers to ensure the functionality and safety of medical devices when transported, stored or operated in high altitude environments.

STEMart provides a full range of services to help manufacturers meet regulatory objectives and minimize compliance risks. This recent expansion demonstrates STEMart’s commitment to providing comprehensive testing solutions that meet the evolving needs of the medical device industry. For more information on Altitude Testing services or or other offerings, please visit https://www.ste-mart.com/medical-device-altitude-testing.htm.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.

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