Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field. Shipping conditions can vary wildly over a range of temperature, impact forces and vibrations, pressure, time, and other factors. U.S. and EU medical device regulations do not call out a “required” set of specifications, so it’s up to the designer to choose a standard or pick their own. ASTM D4169 is a common choice respected by regulatory bodies. Using this standard, rather than defining your own parameters, helps put quantitative values to the possible stresses related to common forms of shipping (rail, truck, air, etc.) as well as other considerations. Medical device susceptibility to shipping conditions also fluctuates widely. Typically… Click Here For Complete Article Text
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