Clause 16 ME Systems – Subject Considerations for application of RM criteria IEC 60601-1 ISO Clauses Clauses 16.1 General After installation or subsequent modification, does the ME 4.2 to 5 Requirements for system result in an unacceptable risk? ME Systems 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? 16.9.1 Connection Are the design and construction of electrical, hydraulic, 4.2 to 6.5 terminals and pneumatic and gas connection terminals and connectors such connectors 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. Clause 17 Electromagnetic compatibility of MEE and MES – IEC 60601-1 Subject Considerations for application of RM criteria ISO 14971 Clauses Clauses 17 Electromagnetic Does the risk management process address the risks 4.2 to 6.5 compatibility of associated with the electromagnetic phenomena existing at the ME equipment locations where the ME equipment or ME System is intended to and ME systems 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? 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
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
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