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IEC 60601-1-2 Edition 4.1: FDA Recognition and Transition Period Updates

The article discusses the release of IEC 60601-1-2 Edition 4.1, an amendment for Medical electrical equipment, addressing concerns from the previous version. The US FDA recognized it as a standard in December 2020, replacing the older edition by December 2023. Declarations referring to the old edition are accepted until then. However, the EU has not announced an official transition period for Edition 4.1, but it is expected that manufacturers will have a 3 to 4-year period post-publication to comply with the new requirements.

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