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 14.9: Design and implementation

What does 14.9 require?

Where appropriate the design is decomposed into subsystems, each with a design specification and a test specification, and descriptive data on the design environment (languages, tools, coding standards and the like) are documented.

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