What is IEC 60601-1?
IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment.
The primary standard governing medical device design is IEC 60601-1 (medical electrical equipment – Part 1: general requirements for basic safety and essential performance). Often referred to simply as “60601,” compliance with the standard has become a de facto requirement to bring new medical devices to market in many countries.
Many of today’s products appear simple; yet embed sophisticated circuits and software that are invisible to the user. The IEC 60601-1 standard manages this reality by becoming intimately involved in the product-development process, going beyond performance test and verification. This is done because the product complexity generally yields a nearly uncountable number of potential test cases, permutations, and combinations in both normal and non-normal operating modes, and these cannot be assessed in the final design alone.
IEC 60601-1 evolution
The IEC 60601 standard has a long history with a number of revisions. The original IEC 60601-1 was published in 1977, and the 2nd revision was published in 1988. The 3rd edition was published by the IEC in 2005.
Because the global shift to IEC 60601-1 3rd edition is still underway, 2nd and 3rd edition standards must still coexist in equipment intended to ship internationally, creating an added level of complexity for device designers who must account for both standards.
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