When performing the usability engineering process and the risk management process there are deliverables from each process that are used as inputs into the other process. Figure 1 indicates in which process these deliverables are generated and which deliverables are necessary for completing the other process. When complying with IEC 60601-1:2005, IEC 60601-1-6:2010, IEC 62366:2007 and ISO 14971:2007 are all required to satisfy the requirements for the Usability Engineering Process. IEC Collateral standard: Usability Guidance for the application of ISO 14971:2007 and IEC 62366:2007 IEC Subject Considerations for application of RM criteria ISO Clauses Clauses 4.2 General Compliance is confirmed through application of IEC 3.2, 3.4d, Requirements IEC 62366:2007 and ISO 14971:2007 4-7 – Conditions for Equipment provides adequate USABILITY such that application to ME resulting from NORMAL USE and USE ERROR are considered EQUIPMENT acceptable Has the USABILITY ENGINEERING PROCESS adequately addressed all associated with NORMAL USE and USE ERROR? 4.1.2 RESIDUAL RISK Compliance is checked by inspection of the USABILITY 6.4 (62366) ENGINEERING FILE Has compliance with Clause 5.9 of IEC 62366:2007 been demonstrated? Has the USABILITY ENGINEERING PROCESS integrated all elements of RISK MANAGEMENT as required by this standard? Have all design changes related to USABILITY been reviewed to determine if any new HAZARDS or HAZARDOUS SITUATIONS have been generated? Has the manufacture adequately addressed all risks related to usability, and have all the risk been mitigated to an acceptable level? 4.1.3 Information for Compliance is checked by inspection of the ACCOMPANYING 5, 6.2 (62366) SAFETY DOCUMENTS and the USABILITY ENGINEERING FILE Has the MANUFACTURER identified any information for SAFETY as a RISK CONTROL MEASURE? If yes, has this information been subject to the USABILITY ENGINEERING PROCESS to determine acceptable USABILITY? If yes, has this information been subject to the RISK MANAGEMENT PROCESS when determining the appropriate RISK CONTROL measure? 4.3 Scaling of the Compliance is checked by inspection of the USABILITY 4.2-4.4 USABILITY ENGINEERING FILE ENGINEERING Has the MANFACTURER scaled the USABILITY effort ENGINEERING PROCESS? If yes, has the MANUFACTURER taken into account the nature of the MEDICAL DEVICE, the intended USER and the INTENDED USE? If yes, does the RISK ANALYSIS indicate the scaling was based on the significance of the modification?
When performing the usability engineering process and the risk management process there are deliverables from each process that are used as inputs into the other process. Figure 1 indicates in which process these deliverables are generated and which deliverables are necessary for completing the other process. When complying with IEC 60601-1:2005, IEC 60601-1-6:2010, IEC 62366:2007 and ISO 14971:2007 are all required to satisfy the requirements for the Usability Engineering Process. IEC Collateral standard: Usability Guidance for the application of ISO 14971:2007 and IEC 62366:2007 IEC Clauses Subject Considerations for application of RM criteria ISO Clauses 4.2 General Requirements – Conditions for application to ME EQUIPMENT Compliance is confirmed through application of IEC IEC 62366:2007 and ISO 14971:2007 Equipment provides adequate USABILITY such that resulting from NORMAL USE and USE ERROR are considered acceptable Has the USABILITY ENGINEERING PROCESS adequately addressed all associated with NORMAL USE and USE ERROR? 3.2, 3.4d, 4-7 4.1.2 (62366) RESIDUAL RISK Compliance is checked by inspection of the USABILITY ENGINEERING FILE Has compliance with Clause 5.9 of IEC 62366:2007 been demonstrated? Has the USABILITY ENGINEERING PROCESS integrated all elements of RISK MANAGEMENT as required by this standard? Have all design changes related to USABILITY been reviewed to determine if any new HAZARDS or HAZARDOUS SITUATIONS have been generated? Has the manufacture adequately addressed all risks related to usability, and have all the risk been mitigated to an acceptable level? 6.4 4.1.3 (62366) Information for SAFETY Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and the USABILITY ENGINEERING FILE Has the MANUFACTURER identified any information for SAFETY as a RISK CONTROL MEASURE? If yes, has this information been subject to the USABILITY ENGINEERING PROCESS to determine acceptable USABILITY? If yes, has this information been subject to the RISK MANAGEMENT PROCESS when determining the appropriate RISK CONTROL measure? 5, 6.2 4.3 Scaling of the USABILITY ENGINEERING effort Compliance is checked by inspection of the USABILITY ENGINEERING FILE Has the MANFACTURER scaled the USABILITY ENGINEERING PROCESS? If yes, has the MANUFACTURER taken into account the nature of the MEDICAL DEVICE, the intended USER and the INTENDED USE? If yes, does the RISK ANALYSIS indicate the scaling was based on the significance of the modification? 4.2-4.4
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