6.2 Risk control option analysis The manufacturer identifies risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable The manufacturer uses one or more of the following risk control options in the priority order listed: a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety The manufacturer records the risk control measure(s) in the risk management file. If, during risk control option analysis, the manufacturer determines that required risk reduction is not practicable, the manufacturer shall conduct a risk/benefit analysis of the residual risk (proceed to 6.5). The CBTL reviews the manufacturer’s chosen risk control measure(s) for each hazard based requirement from IEC 60601 series of standards and documents their findings in the Risk Management Results Tables in the TRF. P 6.3 Implementation of risk control measure(s) The manufacturer implements the identified risk control measure(s). The manufacturer verifies the implementation of each hazard based risk control measure. The effectiveness of the risk control measure(s) shall be verified and the results shall be recorded in the risk management file. The CBTL reviews manufacturer’s implementation, verification and effectiveness of risk control measure(s) for each hazard based requirement from IEC 60601 series of standards and documents their findings in the Risk Management Results Tables in the TRF. P 6.4 Residual risk evaluation After the risk control measures are applied, the manufacturer evaluates any residual risk using the criteria defined in the risk management plan. The results of this evaluation are recorded in the risk management file. If the residual risk is not judged acceptable using these criteria, then the manufacturer applies further risk control measures. For residual risks that are judged acceptable, the manufacturer decides which residual risks to disclose and what information is necessary to include in the accompanying documents in order to disclose those residual risks. The CBTL reviews the manufacturer’s residual risk analysis, risk control looping where necessary, and their determination of information to be included in the accompanying documents. The CBTL verifies compliance with these requirements and records their findings in the Risk Management Results Tables of the TRF for each hazard based risk management from the IEC 60601 series of standards. P
Clause 16 – ME Systems IEC 60601-1 Clauses Subject Considerations for application of RM criteria ISO Clauses 16.1 General Requirements for ME Systems After installation or subsequent modification, does the ME system result in an unacceptable risk? Have hazards arising from combining various equipment to constitute an ME system been considered? Is the level of safety equivalent to ME system complying with this standard IEC 60601-1 within the patient environment? If the ME System is reconfigurable, have risk management methods been used to determine which configurations constitute the highest risks and which measures are needed to ensure that the reconfiguration does not constitute an unacceptable risk? 4.2 to 5 16.9.1 Connection terminals and connectors Are the design and construction of electrical, hydraulic, pneumatic and gas connection terminals and connectors such that incorrect connection of accessible connectors, removable without the use of a tool, can be prevented a HAZARDOUS SITUATION could otherwise exist? Review the manufacturers risk management file for any risk analysis, risk evaluation and risk control measures. Are plugs for patient leads designed to prevent connection to other outlets of the same ME System that are likely to be located in the patient environment unless no hazardous situation can result? Review the manufacturers risk management file for any risk analysis, risk evaluation and risk control measures. 4.2 to 6.5 Clause 17 – Electromagnetic compatibility of MEE and MES IEC 60601-1 Clauses Subject Considerations for application of RM criteria ISO 14971 Clauses 17 Electromagnetic compatibility of ME equipment and ME systems Does the risk management process address the risks associated with the electromagnetic phenomena existing at the locations where the ME equipment or ME System is intended to be used as indicated in the accompanying documents? Does the risk management process address the risks associated with the introduction by the ME equipment or ME system of electromagnetic phenomena into the environment that might degrade the performance of other devices, electrical equipment, and systems? 4.2 to 6.5 Notes: Clauses 3.3a, 3.5e, and 7 shall be included in the complete RM file which has been addressed through clause 4.3. Numbering above is inclusive as applicable. This document includes clauses from IEC 60601-1 which have guidance for inspection requirements of the manufacturer’s risk management file, risk control measures and risk management process. The document does not address other clauses from IEC 60601-1 which include key terms for example RISK (with or without qualifying words such as unacceptable, acceptable and significant), HAZARD, HAZARDOUS
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
9 Accuracy of controls and instruments and protection against hazardous outputs Have the RISKS associated with USABILITY in the HOME HEALTHCARE ENVIRONMENT included consideration of all factors identified by the Standard, placing particular emphasis on the limited training of a LAY OPERATOR with respect to the ability to intervene and maintain BASIC SAFETY and ESSENTIAL PERFORMANCE? If so, review the manufacturer’s USABILITY ENGINEERING FILE for risk analysis, risk evaluation and where necessary implementation of risk control, as well as whether an acceptable residual risk results. See USABILITY ENGINEERING FILE assessment per IEC 11.0 Protection against strangulation or asphyxiation Have means been provided to control the RISK of strangulation and asphyxiation of the PATIENT and others to an acceptable level? If so, review the manufacturers risk management file for risk analysis, risk evaluation and where necessary implementation of risk control, including whether other hazards may have been generated. 4.3-4.4, 5, 6.2-6.6 IEC 62304 Edition 1.0 2006-05 Medical device software –Software life cycle processes When the requirements for software apply for the medical devices, 60601-1 requires compliance with applicable clauses of IEC 62304 that makes normative reference to ISO 14971. In fact in the evaluation of a device with respect to the requirements of 60601-1 which employs PEMS and PESS, a risk management process is required to be followed. According to IEC 60601-1, when the requirements in 14.2 to 14.13 apply, the requirements in subclause 4.3, Clause 5, Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 shall also apply to the development or modification of software for PEMS and for each PESS. IEC makes a normative reference to ISO 14971. However, some minor additional RISK MANAGEMENT requirements are identified for software, especially in the area of identification of contributing software factors related to HAZARDS. These requirements are summarized and captured in Clause 7 of IEC 62304 as the software RISK MANAGEMENT PROCESS. The CBTL needs to ensure the manufacturer has taken into account the additional requirement for the Software Risk Management. Annex 1 ISO 14971:2000 Checklist (Informative) Clause Subject Item References 3.3 a) Management Responsibilities a. Policy for determining acceptable risk. 3.5 e) Risk Management Plan e. Evidence of risk acceptability criteria.