The equipment or system goes through a risk management process that meets ISO 14971, applying every element of the 14971 process except production and post-production monitoring and periodic review of the process itself; wherever 14971 says medical device, read ME equipment or ME system, and fault conditions include at least the single fault conditions the standard identifies; the manufacturer sets the policy for what risk is acceptable and when residual risk can be accepted. Risk is evaluated in three ways: where the standard, a collateral or a particular standard gives requirements with specific acceptance criteria, compliance is presumed to reduce the residual risk to an acceptable level unless there is objective evidence otherwise; where requirements are given without acceptance criteria, the manufacturer states its own criteria in the risk management plan; and where a hazard is only identified for investigation, the manufacturer determines whether it exists and, if so, evaluates and controls it under the process; hazards not addressed by the series are treated in the same process. Compliance is checked by inspecting the manufacturer's risk acceptability policy, the risk management plan and the risk management file with the records the standard requires.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.