9 Accuracy of Have the RISKS associated with USABILITY in the HOME See controls and HEALTHCARE ENVIRONMENT included consideration of all USABILITY ENGINEERING instruments and factors identified by the Standard, placing particular emphasis on FILE protection against the limited training of a LAY OPERATOR with respect to the ability assessment hazardous to intervene and maintain BASIC SAFETY and ESSENTIAL per IEC outputs 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. 11.0 Protection against Have means been provided to control the RISK of strangulation and 4.3-4.4, 5, strangulation or asphyxiation of the PATIENT and others to an acceptable level? 6.2-6.6 asphyxiation 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. IEC 62304 Edition 1.0 2006-05 Medical device software life cycle processes –Software 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 a. Policy for determining Responsibilities acceptable risk. 3.5 e) Risk Management Plan e. Evidence of risk acceptability criteria.
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.
od-2044_ed.2.2.docx