IEC 62304, EN 62304…Confused?

 By Nikhil Chauhan

The requirements of IEC 62304 and EN 62304 are identical.  Both, IEC 62304 and EN 62304, share the same genealogy and are well recognized software life cycle standards. The only difference is that they are promoted by two different standardization bodies. IEC (International Electrotechnical Commission) and CENELEC adopted the same standard concurrently.

IEC 62304 is a worldwide recognized standard from IEC that defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

EN 62304 is promoted by CENELEC, the European committee for Electrotechnical Standardization which is officially recognized by the European Commission. According to Cenelec’s site, “CENELEC makes sure that the majority of its Standards are identical to the Standards developed by the IEC, the International Electrotechnical Commission. This is achieved thanks to the intense cooperation between both organizations, laid down in the Dresden Agreement, and through the participation of CENELEC members directly in IEC work.” The site also states, “In overall terms, 79% of CENELEC Standards are identical to or based upon IEC’s.” Per the description here, EN 62304 referenced IEC 62304 and also defines the life cycle requirements for medical device software. Just like IEC 62304, the set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

Conformance to either/both provides the evidence of having a software development process in place, and fulfills part of requirements of FDA’s 21 CFR 820.50 quality system regulation as well as the Medical Device Directive 93/42/EEC.

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