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Safety-Slide13

Due to the growing use of devices like smart phones, laptops, and tablets that communicate wirelessly, the 4th edition of the IEC 60601-1-2 collateral standard was introduced to address a reciprocal concern about electromagnetic compatibility (EMC) affecting both the medical device in question and other devices in the vicinity. In the past, it may have been possible to exclude these sources of interference from sensitive medical environments, such as hospitals, but with more and more medical equipment now intended to operate in the home and other environments, EMC concerns had to be taken into account. These “intended use environments” introduced in the 4th edition are specifically defined in three categories: professional healthcare facilities with attending medical staff such as hospitals, home healthcare defined in collateral standard IEC 60601-1-11, and “special” environments that contain high levels of electromagnetic disturbance (e.g. radio-therapy equipment). The US, Canada, and member countries of the European Union officially adopted the new 4th edition EMC standards from December 31, 2018, but outside of these major countries adoption of the various revisions of IEC 60601-1 is a mixed picture, with transition to the 4th edition being unclear.

PTM Published on: 2014-07-28
PTM Updated on: 2018-11-05