What is EN60601 and IEC 60601?

IEC 60601-1 is the international standard for medical electrical equipment safety and essential performance. However, for devices marketed in Europe, compliance with EN 60601-1 is necessary.

EN 60601-1 is the European harmonized version of IEC 60601-1 and includes additional region-specific requirements mandated by the European Union.

While both standards share the same fundamental framework, EN 60601-1 often incorporates additional requirements related to EU Medical Device Regulations (MDR) and specific directives. Manufacturers planning to market in Europe must ensure that their device meets these additional criteria.

By proactively addressing the requirements for IEC60601 and EN60601, medical device manufacturers can significantly reduce delays and regulatory hurdles. At Meka Innovation, we specialize in helping businesses design, prototype, and launch innovative medical devices while ensuring compliance with industry standards.

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