Appendix B for RISK MANAGEMENT

APPENDIX BIEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 4 - General requirements 4.2 Risk Management Process for ME Equipment or ME Systems Compliance is checked by inspection of the risk management file. The requirements of this clause and all requirements of this standard referring to inspection of the risk management file are considered to be satisfied if the manufacturer has: -established a risk management process; and -established acceptable levels of risks; and -demonstrated that the residual risk is acceptable. Does the manufacturer have a risk management process according to ISO14971 in place? Was this process used for the device being considered? If so, a limited number of more detailed questions can be addressed at this point: Are all risk management procedures (that meet the requirements of ISO14971, including acceptability criteria) developed and applied for the device considered (clauses 4-9 of ISO14971)? Is there a risk management plan (including resources and commitment) for the device considered (clause 3 of ISO14971)? Is the overall residual risk for the device considered acceptable? 3 to 9 4.3 Essential performance Compliance is checked by inspection of the risk management file. Have, apart from the essential performance identified in the particular standards, hazardous situations be identified whereby the residual risk is unacceptable due to the absence of performance of the device? If so, has this performance been identified as essential performance for the device during the risk assessment process? If so, have risk control measures or particular tests been identified to check whether this performance is maintained? If so, has this been checked by inspection or by functional test? 4 5 6.4 4.4 Expected service life Compliance is checked by inspection of the risk management file. Has the expected service life of the device been identified? Inspection IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 4.5 Equivalent safety for ME Equipment of ME System Compliance is checked by inspection of the risk management file. Are there particular risks for which alternative means of controlling these risks are applied such that the resulting risk level is acceptable for these risks? If so, have these risks been identified as such during the risk assessment process? If so, is the resulting risk level equal or less than the residual risk that results from applying the requirements of this standard? 4 5 4.6 ME equipment or ME system parts that contact the patient Compliance is checked by inspection of the RISK MANAGEMENT FILE. Have parts been identified during the risk management process which can come into contact with the patient but fall outside the definition of applied parts? If so, are all the relevant requirements and tests of this standard applied? If so, are there residual risks which are not acceptable? If so, are risk controls measures implemented that make the residual risk acceptable? 4 to 9 4.7 Single Fault Condition for ME Equipment Compliance is determined by applying the specific requirements and tests associated with the single fault conditions identified in 13.2, and tests for the failures identified from evaluation of the results of the risk analysis. Compliance is determined if the introduction of any of the single fault conditions described in 13.2, one at the time, does not lead directly to the hazardous situations described 13.1, or any other outcome that results in an unacceptable risk. Are there single fault conditions which lead directly to hazardous situations described in 13.1 or to risks that are unacceptable? 4 to 9 4.8 Components of ME Equipment Compliance is checked by inspection and, where necessary, by test. The tests of this standard for motors (see 13.2.8 and 13.2.13.3) and transformers (see 15.5.3) are considered to be comprehensive and together with the evaluation of the motor or transformer insulation system according to Table 22 represent all testing required by this standard. ME system components that provide isolation from non-ME equipment are evaluated to clause 16. Are specific exceptions made for any component of the device under investigation to allow it to be used not in accordance with its specified rating? If so, are these exceptions formulated as the result of the risk management process? If so, have inspection or test requirements been formulated to make the hazardous situations acceptable? 4 to 9 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 4.9 Use of components with high-integrity characteristics in ME Compliance is checked by inspection of the risk management file and the selection criteria for the components with high-integrity characteristics. Are components with high-integrity characteristics applied? If so, have the risks associated with its use been identified as such during the risk assessment process, or in other words are they selected and evaluated consistent with their conditions of use and reasonably foreseeable misuse during the expected service life of the ME equipment? 4 5 5 - General requirements for testing MEE 5.1 Type Tests The tests to be performed are determined taking into consideration the requirements of clause 4, in particular 4.2. For the selection of the tests to be performed, is a risk management process according to ISO14971 applied? If so, this requirement is fulfilled. The results of the risk analysis are used to determine which combination(s) of simultaneous faults are to be tested. For the determination of which combination(s) of simultaneous faults have to be tested, is a risk assessment applied? 4 to 9 5.4 a) Other conditions Unless otherwise specified in this standard, ME equipment is to be tested under the least favorable working conditions as specified in the Instructions for Use that are identified during the risk analysis. For testing of the ME equipment, have the least favorable working conditions been identified via the risk analysis? 4 5.7 Humidity preconditioning treatment Where the risk management process suggests that the ME equipment can be exposed to high humidity for extended periods, the period is extended appropriately. Has it been determined via the application of the risk management process whether the ME equipment can be exposed to high humidity for extended periods? If so, is the period for testing been extended appropriately following the conclusions of the risk management process? 3 - 9 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 5.9.2.3 Actuating mechanisms Inspection of the risk management file demonstrates that the relevant part is unlikely to become detached unintentionally during the expected service life of the ME equipment. Has the result of the risk analysis demonstrated that the relevant part is unlikely to become detached unintentionally during the expected service life time of the ME equipment and that an acceptable residual risk results? 4 MEE Identification, markings and documents 7.1.1 Usability of the identification, marking and documents Compliance is checked by inspection of the usability engineering process. Has the manufacturer addressed in a usability engineering process the risk of poor usability? 4 7.9.1 General accompanying documents format. (see also Table C.4) Compliance is checked by inspection of the risk management file. Has the manufacturer applied the risk management process to determine which information also needs to be provided as hard copy or as marking on the ME equipment? 4 5 8 - Protection against electrical hazards from MEE 8.1 b Fundamental rule of protection against electric shock Has the manufacturer identified in their risk analysis if the interruption of any one power carrying conductor between MEE parts in separate enclosures might cause permitted limits (voltage, current, energy) to be exceeded? If so, then during product safety verification, this must be one of the SFCs tested. Has the manufacturer identified in their risk management process that a components movement must be considered as a SFC because its lack of securement (8.10.1) over the expected service life of the MEE may cause permitted limits (voltage, current, energy) to be exceeded? If so, then during product safety verification, this must be one of the SFCs tested. 4.3 4.4 8.3 d Classification of applied parts Has the manufacturer identified in their risk management process the need for parts (not being applied parts) to be subject to the requirements for an applied part of Type BF or Type CF? If so, then during product safety verification, these parts are to be tested accordingly. 4.3 4.4 5 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 8.4.2 c Accessible parts including applied parts Has the manufacturer identified parts (not being applied parts) where a current exceeding the allowable touch current could flow, either directly or through the body of an operator, however, the risk analysis determined that the probability in normal use is negligible? If so, then during product safety verification, these identified parts do not require touch current testing. Inspect the instructions for use includes instructions for the operator not to touch the relevant part and the patient simultaneously. 4 8.5.2.2 Type B applied parts Has the manufacturer identified in their risk management file, unearthed Type B applied parts that are not separated from unearthed conductive accessible parts, however, determined that the level of risk that the unearthed accessible part will make contact with a source of voltage or leakage current above permitted limits is acceptably low? If so, accepted. If not, then one means of protection is required. 4 5 8.5.2.3 PATIENT Leads Has the manufacturer identified in their risk management process connectors for electrical connections on a patient lead at the end of the lead remote from the patient and that contains a conductive part that is not separated from all patient connections by one MOPP for a working voltage equal to the maximum mains voltage, that will not present an unacceptable risk from contact with objects other than a mains socket or a flat surface (e.g. corners or edges)? If so, during product safety verification, the test using a straight unjointed test finger with a force of 10 N is not required, however, the remaining inspections of this clause are required. 4 5 8.6.3 Protective earthing of moving parts Does the manufacturers risk management file indicate the need to bond moving parts to the protective earth connection? If so, has the manufacturer demonstrated the reliability of the connection during the expected service life? 4-6 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 8.8.4.1 Mechanical strength and resistance to heat Has the manufacturer identified in the risk management file the need for insulations of all types, considering its resistance to heat in the application and the expected service life? Has the manufacturer identified any specific test protocols that must be performed during product safety verification? If so, conduct the tests required in this clause and any additional tests or inspections identified in the risk management file. 4-6 8.10.1 Fixing of components Has the manufacturer identified components the movement of which could result in an unacceptable risk in their risk management file? If so, verify that such identified components are securely mounted and will remain so for the expected service life. 4-6 8.10.2 Fixing of wiring Has the manufacturer identified in their risk management file the need to restrain by double securement any conductors and connectors where if they were to break free and touch circuit points this could result in a hazardous situation? If so, inspect the construction and restraint of these conductors and connectors to ensure that they are held in place by use of double securement. 4-6 8.10.5 Mechanical protection of wiring Has the manufacturer identified in the risk management file the need to protect against contact with moving parts, friction at sharp corners and edges or damage during assembly or the opening or closing of access covers of internal cables, wiring, cord forms or components, where the damage or insulation damage could result in a hazardous situation? If so, inspect these parts carefully considering their location and potential damage during assembly, disassembly, contact with moving parts and friction at sharp corners and edges. 4-6 8.11.5 Mains fuses and over-current releases Has the manufacturer provided justification for omission of fuses or over-current releases in the risk management file? If so, inspect the circuit according to the requirements of this clause ensuring double insulation and acceptable fault condition tests results. 4-6 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 9 - Protection against mechanical hazards of MEE and MES 9.2.1 HAZARDs associated with moving parts - General - Are protective measures used to reduce the risk from contact with moving parts? -Considering use as indicated in the Accompanying Documents or reasonably foreseeable misuse and bearing in mind the ease of access, the ME Equipment function, the shape of the parts, the energy and speed of the motion and the benefits to the patient, is this risk reduced to an acceptable level? - Is exposure to moving parts needed for MEE to perform its intended function? - Have all reasonable protective measures including warning markings on the MEE where the hazards persist been implemented? 3 to 9 9.2.2.4.3 Movable guards - The risks caused by mechanical hazards associated with moving parts and reduced by use of the movable guards are addressed? 3 to 9 9.2.2.4.4 Protective measures - The risks caused by mechanical hazards associated with moving parts and reduced by the use of protective measures incorporated in the control system are addressed? 3 to 9 9.2.2.5 c Continuous activation - The risks caused by mechanical hazards associated with accessibility to a trapping zone and reduced by use of the continuous activation of the movement control are addressed? 3 to 9 9.2.2.6 Speed of movement(s) - The risks caused by mechanical hazards associated with the speed of movement are addressed? 3 to 9 9.2.3.2 Over travel - The risks caused by mechanical hazards associated with the over travel are addressed? 3 to 9 9.2.4 Emergency stopping devices - Does the MEE use emergency stopping devices? - Are risks caused by mechanical hazards which are reduced by the use of the emergency stopping devices reduced to an acceptable level? 3 to 9 9.2.5 Release of patient - The risks caused by mechanical hazards associated with release of patient are addressed? 3 to 9 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 9.3 Hazards associated with surfaces, corners and edges - The risks caused by mechanical hazards associated with surfaces, corners and edges are addressed? 3 to 9 9.4.2.4.3 Movement over a threshold - Are the risks caused by mechanical hazards associated with movement over a threshold addressed? 3 to 9 9.5.1 Protective means - Have the risks caused by mechanical hazards associated with expelled parts been addressed? 3 to 9 9.6.1 Acoustic energy General - Have the risks caused by mechanical hazards associated with acoustic energy and vibration been addressed? 3 to 9 9.6.2.2 Infrasound and ultrasound energy - Have the risks caused by mechanical hazards associated with infrasound and ultrasound energy been addressed? 3 to 9 9.7.2 Pneumatic and hydraulic parts -Have the risks caused by mechanical hazards associated with pneumatic and hydraulic parts been addressed? 3 to 9 9.7.4 Pressure rating of ME equipment parts - Have the risks caused by mechanical hazards associated with pressure rating of MEE parts been addressed? 3 to 9 9.7.6 Pressure-control device Have the risks caused by mechanical hazards associated with pressure control device been addressed? 3 to 9 9.7.7 Pressure-relief device Have the risks caused by mechanical hazards associated with a pressure-relief device been addressed? 3 to 9 9.8.1 Hazards associated with support systems General Have the risks caused by hazards arising from static, dynamic, vibration, impact and pressure loading, foundation and other movements, temperature, environmental, manufacture and service conditions been addressed? Were all of the following failures considered: excessive deflection, plastic deformation, ductile or brittle fracture, fatigue fracture, instability (buckling), stress-assisted corrosion cracking, wear, material creep, and material deterioration? Were the following residual stresses resulting from the manufacturing process, e.g. machining, assembling, welding, heat treatment or surface coating considered? 3 to 9 IEC 60601-1: 2005 3rd edition risk management requirements guidance for the application of ISO 14971: 2000 1st edition Clause Subject Considerations for application of RM criteria Evidence ISO 14971: 2000 9.8.2 Tensile safety factor When not according to Table 21, what alternative method was used to determine the tensile safety factor? Have the risks related to the value of the tensile factor been addressed? 3 to 9 9.8.3.1 Strength of patient or operator support or suspension systems General Have the risks caused by mechanical hazards associated with support or suspensions of the patient (including particular applications) been addressed? 3 to 9 9.8.3.2 a&b Static forces due to loading from persons Have the risks caused by mechanical hazards associated with static forces due to loading from persons been addressed? 3 to 9 9.8.4.1 Systems with mechanical protective devices- General Does the MEE use mechanical protective devices? Does the mechanical protective device activate before travel (movement) produces an unacceptable risk? 3 to 9 9.8.4.3 Mechanical protective device intended for single activation Does the MEE use mechanical protective devices intended for single activation? Where risks caused by mechanical hazards which have been reduced by the use of mechanical protective devices intended for single activation: 3 to 9 9.8.5 Systems without Has the manufacturer determined t