IEC 60601-1 - Medical Electrical Equipment Safety
Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 14.12: 14.12 Modification

Where any part of a design results from modifying an earlier design, either the entire clause is applied as though the design were new, or an assessment is made of whether the earlier design documentation remains valid under a documented modification or change procedure; and software modification also follows IEC 62304's classification, development, risk management, configuration management and problem resolution requirements.

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