Note: This post was originally published October 31, 2017 and updated on February 12, 2019 to reflect the latest timeline for adoption of IEC 60601-1 worldwide.
The IEC 60601-1 standard, which provides general requirements that address the basic safety and essential performance of medical electrical equipment, has evolved through a number revisions since its first publication in 1977. Keeping on top of these revisions and new editions of the standard has proven to be a challenge for medical device designers because of their many regional variations and differing adoption timelines around the globe.
With the introduction of the 4th edition of collateral standard IEC 60601-1-2 (“Electromagnetic disturbances – Requirements and tests”) in 2014, the global landscape has become even more unclear. To help illustrate the adoption timeline of IEC 60601-1 as it relates to various territories worldwide, we have developed this country compliance infographic that highlights the evolution of the different editions now and into the future.
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