Medical devices used for home healthcare are designed to specifically to ensure safety.
Have you ever wondered about how a medical device in the home is defined?
IEC 60601-11 defines Healthcare Environment as: “Dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.”
Because care recipients expect to be able to stay independent, mobile, and active, the term “home use” extends beyond the home, to encompass all environments in which a person plans to use his or her medical device in day-to-day life. Whether jogging, camping, skiing, or biking, the device must be capable of safely accommodating the many needs of the person using it. The standard, therefore, goes beyond 60601-1 3rd Edition.
Key design considerations include:
What questions do you have regarding home healthcare product safety and quality? Please leave your comment or questions below and one of our experts will get back with you.
Today’s expert blogger is Todd R. Konieczny, Assistant Chief Engineer, Intertek Americas Region. Todd is located in the Boxborough, Massachusetts office.
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