In the context of electromedical devices, and particularly in the context of programmable electronic equipment, the analyzes carried out within the risk management are performed in accordance with the requirements of the IEC 60601-1 and ISO 14971.
The first objective of risk management is to define a risk acceptability policy. The second objective, starting from the adopted risk management policy, is to achieve:
- the "basic safety": that is, the absence of unacceptable risks directly caused by physical hazards in normal condition or in single fault condition;
- the "essential performance": performance necessary to remove the unacceptable risk, or those functions, defined by the manufacturer, whose absence or degradation could constitute an unacceptable risk.
The methodology used by HINTSW - T & T Systems to achieve the above steps is to carry out the following activities required by ISO 14971:
- Risk Analysis:
- determination of the designed use and identification of the device characteristics;
- hazards identification;
- estimate of the risk related to any situation of danger (sequences or combination of reasonably foreseeable events that can lead to a dangerous situation).
- Risk assessment: for each identified hazardous situation you have to decide if you need to undertake a risk reduction.
- Risk control:
- analysis of the various options for risk reduction;
- implementation of risk control measures;
- assessment of the residual risk;
- analysis of risks / benefits;
- identification of any further risks resulting from the control measures;
- evaluation of the completeness of risk control, ie checking if it was exhaustively considered the risk related to all identified hazardous situations.
The finalization of the above activities is to fill out the "risk management file (RMF)" that registers all assessments and the results of the analyzes.