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 14.6: 14.6 Risk management process

When compiling known and foreseeable hazards the manufacturer considers those of the PEMS's software and hardware aspects, including incorporation into an IT-network, third-party components and legacy subsystems, such as failure of the network to provide the characteristics basic safety or essential performance needs, undesired physical or data feedback (unsolicited, out-of-range or inconsistent input, electromagnetic interference), unavailable, corrupted, incorrect or mistimed data, unintended interactions within and among subsystems, unknown quality of third-party software and subsystems, and lack of data security including privacy effects and vulnerability to tampering, unintended program interaction and viruses; and, in addition to the 4.2.2 risk control, appropriately validated procedures and tools are chosen and named for putting each risk control measure into effect, appropriate to assure that each measure satisfactorily reduces the identified risk.

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