Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

2.5.2.2 International Organization for Standardization (ISO) Standards

The primary standard from ISO used in the design of medical devices is ISO 14971, “Medical devices - Application of risk management to medical devices.” Risk management plays a critical and central role in the design of medical devices, and it also ties into IEC 60601-1 and FDA’s expectations for quality systems and premarket clearance or approval. Potential hazards must be identified and then assigned ratings of the probability of occurrence of harm and of the severity of the consequences of that harm. These ratings are combined to generate a risk level. If the risk level is high enough, the design must incorporate mitigations to control the risk. The risk mitigation measures must also be assessed to confirm their effectiveness at reducing the risks to acceptable levels and to ensure that they did not introduce any new hazards or risks.