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The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard. Requirements of may be overridden or bypassed by specific language in the standards for a particular product. Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment. IEC must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 3rd edition series. The table below lists all of the IEC X standards, known as collateral standards.
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