IEC 601-1-4 withdrawal

The new version of IEC 60601-1 (3rd edition, 2005) replaces IEC 60601-1-4, not just ISO 14971. IEC 60601-1-4 includes both risk management requirements and PEMS development process requirements.

IEC 60601-1-4 remains a harmonized standard in the EU to meet the essential requirement of the MDD on PEMS, if the 2nd edition of IEC 60601-1 is being referenced. It is superseded by the 3rd edition of IEC 60601-1, which includes the PEMS process requirements and a normative reference to ISO 14971. So, if compliance to the 3rd edition of IEC 60601-1 is being claimed, IEC 60601-1-4 is not necessary. After the transition period to the third edition of IEC 60601-1 is over, IEC 60601-1-4 will be withdrawn.

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