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What are the challenges the home environment can present when related to medical devices?
When designing a medical device for home use, have you thought about the challenges the home environment presents?
While the acute care setting is a controlled, professional environment, the use of medical devices in the home presents unique challenges, many of which have the potential to impact patient safety. For example, home use medical devices may be exposed to environmental risks that may adversely affect performance. These risks can include:
Based on these potential risks, the following tests need to be conducted to show that the medical product is robust for use in the home environment. These tests include:
So, how does your design stack up with the mandatory IEC 60601-1-11 collateral standard for U.S., Canadian and European market access? Please leave a comment below and one of our medical device experts will get back to you.
Today's expert blogger is Todd R. Konieczny, Assistant Chief Engineer, Intertek Americas Region. Todd is located in the Boxborough, Massachusetts office.