6.2 Risk control option The manufacturer identifies risk control measure(s) that are P appropriate for reducing the risk(s) to an acceptable analysis 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. 6.3 Implementation of risk P The manufacturer implements the identified risk control measure(s). The manufacturer verifies the implementation control measure(s) 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. 6.4 Residual risk evaluation After the risk control measures are applied, the P 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.
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
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