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 14.8: Architecture

What does 14.8 require?

For the PEMS and each subsystem an architecture is specified that satisfies the requirement specification, using where appropriate to reduce risk components with high-integrity characteristics, fail-safe functions, redundancy, diversity, partitioning of functionality and defensive design such as limiting available output power or actuator travel, and taking into consideration how risk control measures are assigned to components and subsystems (sensors, actuators, subsystems, interfaces), component failure modes and effects, common cause failures, systematic failures, test interval and diagnostic coverage, maintainability, protection from reasonably foreseeable misuse, and the IT-network specification where applicable.

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