Guidelines For Risk Management in Medical Electrical Equip

GUIDELINES FOR RISK MANAGEMENT IN MEDICAL ELECTRICAL EQUIPMENT See Appendix A 1.
Scope The scope of these guidelines is to give an uniform approach on how to assess compliance with the relevant clauses of IEC 60601-1:2005 related to ISO 14971:2000. 2. Reference documents IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 14971:2000, Medical devices Application of risk management to medical devices IECEE - CB Scheme - TRF60601-1_d 3. Terms and definitions For the purposes of this Guide, the terms and definitions of ISO 14971:2000 and IEC 606011:2005 apply. For the purpose of this document the Risk Management System is a management system intended to address all activities related to ISO14971. 4. Application of Risk Management Principle for IEC 60601-1:2005 CB Scheme investigations 4.1 General The third edition of IEC 60601-1 is the primary standard in a series of standards that covers safety and essential performance of medical electrical equipment. It is the first IEC standard in the scope of the CB Scheme that incorporates risk management principles according to ISO 14971. The introduction of Risk Management is the reason for this guide. The existence of a CB Test Certificate does not establish solely legal market entry. However, it could be used to help substantiate a request for legal market access. This guideline is related solely to the IECEE CB Scheme and is intended for use by those individuals with a working knowledge of risk management for medical electrical equipment and the provisions of the IEC 60601-1:2005. 5. Guidance on how to address Risk Management principles in the IEC 60601-1 CB Scheme investigations 5.1 General principles There is a general requirement to perform the risk management process as specified in ISO 14971 (IEC 60601-1, Clause 4.2.) The registration to ISO 13485 is not sufficient to demonstrate that a risk management process compliant with ISO 14971 requirements is performed. There can be no investigation to IEC 60601-1 third edition without the manufacturers Risk Management File being available. 1/3
In the clauses of IEC 60601-1 there are three types of references to ISO 14971 Risk Management requirements: 1. Direct reference to Risk Management Process as specified by ISO 14971 (for example clause 4.2). 2. Test related references to give appropriate alternative to the application of laboratory testing with specific pass/fail criteria or to select appropriate tests to be performed on the specific product (for example clause 5.7). 3. Indirect reference to offer additional elements to be considered in the implementation of the Risk Management Process specified by ISO 14971 for the specific product. (for example clause 14.1) The CB Test Report and Certificate confirms that there is a Risk Management Process performed which complies with ISO 14971. This does not mean that a complete Risk Management System in compliance with ISO 14971 is in place However, the CB Test Report is only a snapshot in time and does not necessarily assess top management responsibilities, such as, but not limited to, provision of adequate resources and assignment of qualified personnel. In view of the above and similar to the second edition, the CB report according to IEC606011:2005 is not necessarily a guarantee of certification by an accepting NCB. A separate certification of registration to ISO 14971 means that a risk management system fully conforming to ISO 14971 is in place, but does not provide the risk management device specific documentation necessary to meet the requirements of IEC 60601-1. IEC 60601-1 requires specific Risk Management activities to be done and the CB test report requires objective evidence that these activities have been performed for the device in question. A CB Scheme Certificate does not imply that an audit of the manufacturers Risk Management System was conducted. A certificate of registration may be requested for local or regional certification to IEC 60601-1 as it relates to follow-up services. There may be differences in requirements that are the subject of local legal market entry requirements. To assess the requirements for Risk Management process required by IEC 60601-1, the CB Scheme utilizes an addendum embedded within the IEC60601-1 TRF containing reference to the manufacturer's documents intended to support objective evidence of compliance. The table in Appendix A provides mapping with all the Risk Management clauses of IEC606011:2005 and the clauses in ISO 14971 that are referenced in the TRF Addendum. In filling in the TRF addendum, the user of the map should consider applicability of clauses to the Device Under Test. 5.2 Workflow 1. Based on the TRF, establish the relevant clauses of IEC60601-1 that have to be supported by RM documentation 2. Verify the required documentation and identify the relevant reference points to be listed in the TRF 3. In case the use of RM influences the tests 3.1. Identify the test to be conducted 3.2. Identify the test parameters and conditions to be used performing the tests 2/3
3.3. Verify the pass/fail criteria. The pass/fail criteria and the rationale for acceptance shall be reported in the TRF. 3.4. Perform the test and report the result in the TRF
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APPENDIX A Clause
60601-1:2005 Topic
3.2 Risk Management Process
3.3 Management Responsibilities
3.4 Qualification of Personnel
3.5
Risk Management Plan
4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE
4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.6 PATIENT 4.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.9 CHARACTERISTICS in ME EQUIPMENT 4.10' Power supply 4.10.1 Source of power for ME EQUIPMENT 4.10.2 4.11 5 5.1 5.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples
5.3 Ambient temperature, humidity, atmospheric pressure 5.4 Other conditions Supply voltages, type of current, nature of supply, 5.5 frequency 5.6 Repairs and modifications 5.7 Humidity preconditioning treatment 5.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.9 PARTS 5.9.1 APPLIED PARTS 5.9.2 ACCESSIBLE PARTS 5.9.2.1 Test finger 5.9.2.2 Test hook 5.9.2.3 Actuating mechanisms
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6 Classification 6.1 General 6.2 Protection against electric shock Protection against harmful ingress of water or 6.3 particulate matter 6.4 6.4 Method(s) of sterilization 6.5 6.6 7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification, marking and documents General USABILITY of the identification, marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable
7.2.2 Identification 7.2.3 Consult ACCOMPANYING DOCUMENTS 7.2.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
7.2.13 7.2.14 7.2.15 7.2.16
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7.2.17 7.2.18 7.2.19 7.2.20
Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.3 EQUIPMENT parts (see also Table C.2) 7.3.1 Heating elements or lampholders 7.3.2 HIGH VOLTAGE parts
7.3.3 Batteries Fuses, THERMAL CUT-OUTS and OVER-CURRENT 7.3.4 RELEASES 7.3.5 PROTECTIVE EARTH TERMINALS 7.3.6 FUNCTIONAL EARTH TERMINALS 7.3.7 Supply terminals 7.3.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.4 C.3) 7.4.1 Power switches 7.4.2 Control devices 7.4.3 Units of measure
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights
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7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS
General (see also Table C.4) Instructions for use (see also Table C.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.9.2.3 power supply 7.9.1 7.9.2 7.9.2.1 7.9.2.2 7.9.2.4 Electrical power source
ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning, disinfection and sterilization Maintenance ACCESSORIES, supplementary equipment, used 7.9.2.14 material 7.9.2.5 7.9.2.6 7.9.2.7 7.9.2.8 7.9.2.9 7.9.2.10 7.9.2.11 7.9.2.12 7.9.2.13
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
Environmental protection Reference to the technical description Technical description (see also Table C.6) General
Replacement of fuses, POWER SUPPLY CORDS and 7.9.3.2 other parts 7.9.3.3 Circuit diagrams, component part lists, etc. 7.9.3.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.1 Fundamental rule of protection against electric shock 8.2 Requirements related to power sources 8.2.1 Connection to a separate power source
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8.2.2 Connection to an external d.c. power source
8.3 Classification of APPLIED PARTS 8.4 Limitation of voltage, current or energy 8.4.1 PATIENT CONNECTIONS intended to deliver current
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.4.3 source by a plug 8.4.4 Internal capacitive circuits 8.5 Separation of parts 8.5.1 MEANS OF PROTECTION (MOP)
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS
8.5.2.2 TYPE B APPLIED PARTS
8.5.2.3 PATIENT leads 8.5.3 MAXIMUM MAINS VOLTAGE 8.5.4 WORKING VOLTAGE 8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
8.5.5.1 Defibrillation protection 8.5.5.2 Energy reduction test
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Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL
8.6.3 8.6.4 8.6.5 8.6.6
Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets
8.6.7 POTENTIAL EQUALIZATION CONDUCTOR 8.6.8 FUNCTIONAL EARTH TERMINAL 8.6.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.7 CURRENTS 8.7.1 General requirements 8.7.2 SINGLE FAULT CONDITIONS 8.7.3 Allowable values 8.7.4 Measurements 8.7.4.1 General 8.7.4.2 Measuring supply circuits 8.7.4.3 Connection to the measuring supply circuit 8.7.4.4 Measuring device (MD) 8.7.4.5 Measurement of the EARTH LEAKAGE CURRENT 8.7.4.6 Measurement of the TOUCH CURRENT 8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT 8.7.4.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.8 Insulation 8.8.1 General Distance through solid insulation or use of thin sheet 8.8.2 material 8.8.3 Dielectric strength 8.8.4 Insulation other than wire insulation
8.8.4.1 Mechanical strength and resistance to heat
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8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12
Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS
8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c. Minimum CREEPAGE DISTANCES for two MEANS OF 8.9.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.9.1.15 DEFIBRILLATION-PROOF APPLIED 8.9.2 Application 8.9.3 Spaces filled by insulating compound 8.9.3.1 General Insulating compound forming solid insulation between 8.9.3.2 conductive parts Insulating compound forming a cemented joint with 8.9.3.3 other insulating parts 8.9.3.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.9.4 CLEARANCES 8.10' Components and wiring 8.10.1 Fixing of components
8.10.2 Fixing of wiring 8.10.3 Connections between different parts of ME EQUIPMENT
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Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords
8.10.5 Mechanical protection of wiring
8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5
Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS, components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection
8.11.5 Mains fuses and OVER-CURRENT RELEASES 8.11.6 9 9.1 9.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts
9.2.1 General 9.2.2 9.2.2.1 9.2.2.2 9.2.2.3 TRAPPING ZONE General Gaps Safe distances
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9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS
9.2.2.4.3 Movable GUARDS
9.2.2.4.4 Protective measures
9.2.2.5 Continuous activation
9.2.2.6 Speed of movement(s) 9.2.3 Other HAZARDS associated with moving parts 9.2.3.1 Unintended movement 9.2.3.2 Overtravel 9.2.4 Emergency stopping devices 9.2.5 Release of PATIENT 9.3 9.4 9.4.1 9.4.2 9.4.2.1 9.4.2.2 9.4.2.3 9.4.2.4 HAZARD associated with surfaces, corners and edges Instability HAZARDS General Instability overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels
9.4.2.4.1 General 9.4.2.4.2 Force for propulsion 9.4.2.4.3 Movement over a threshold
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Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD
9.5.1 Protective means 9.5.2 Cathode ray tubes Acoustic energy (including infra- and ultrasound) and 9.6 vibration
9.6.1 General 9.6.2 Acoustic energy 9.6.2.1 Audible acoustic energy
9.6.2.2 Infrasound and ultrasound energy 9.6.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.7 hydraulic pressure 9.7.1 General 9.7.2 Pneumatic and hydraulic parts 9.7.3 Maximum pressure
9.7.4 Pressure rating of ME EQUIPMENT parts 9.7.5 Pressure vessels
9.7.6 Pressure-control device
9.7.7 9.7.8 9.8 9.8.1
Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General
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9.8.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.3 suspension systems
9.8.3.1 General
9.8.3.2 Static forces due to loading from persons
9.8.3.3 Dynamic forces due to loading from persons 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.4.1 General Use after activation of a MECHANICAL PROTECTIVE 9.8.4.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.8.4.3 activation
9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.1.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.1.2 therapeutic X-radiation Alpha, beta, gamma, neutron and other particle 10.2 radiation 10.3 Microwave radiation 10.4 Lasers and light emitting diodes (LEDs)
10.5 Other visible electromagnetic radiation
10.6 Infrared radiation
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10.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.1 Excessive temperatures in ME EQUIPMENT
11.1.1 Table 23 Parts likely to be touched
11.1.1 Table 24 Skin contact with AP
11.1.2 Temperature of APPLIED PARTS 11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
11.1.2.2
APPLIED PARTS not intended to supply heat to a PATIENT
11.1.3 Measurements
11.1.4 GUARDS 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.2.2 with OXYGEN RICH ENVIRONMENTS
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11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT
External exhaust outlets for OXYGEN RICH 11.2.2.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2.2.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents
11.2.3 11.3 11.4 11.5
Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME 11.6 EQUIPMENT 11.6.1 General
11.6.2 Overflow in ME EQUIPMENT 11.6.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.6.4 Leakage Ingress of water or particulate matter into ME 11.6.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11.6.6 SYSTEMS 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11.6.8 Compatibility with substances used with the ME EQUIPMENT
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
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Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output
12.4.1 Intentional exceeding of safety limits
12.4.2 Indication of parameters relevant to safety
12.4.3 Accidental selection of excessive output values 12.4.4 Incorrect output 12.4.5 Diagnostic or therapeutic radiation 12.4.5.1 Limits 12.4.5.2 Diagnostic X-ray equipment 12.4.5.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.4.5.4 therapeutic radiation 12.4.6 13 13.1 13.1.1 13.1.2 13.1.3 13.1.4 13.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions, deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS
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13.2.1 13.2.2 13.2.3 13.2.4 13.2.5
General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices
13.2.6 Leakage of liquid 13.2.7 Impairment of cooling that could result in a HAZARD 13.2.8 Locking of moving parts 13.2.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.2.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.2.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.2.12 HAZARD 13.2.13 Overload 13.2.13.1 General overload test conditions 13.2.13.2 ME EQUIPMENT with heating elements 13.2.13.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.2.13.4 OPERATION 14 Programmable electrical medical systems
14.1 General 14.2 Documentation 14.3 14.4 14.5 14.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS
14.6.1 Identification of known and foreseeable HAZARDS 14.6.2 RISK CONTROL 14.7 Requirement specification 14.8 Architecture
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14.9 Design and implementation 14.10' VERIFICATION
14.11 PEMS VALIDATION 14.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.1 EQUIPMENT
15.2 Serviceability 15.3 Mechanical strength 15.3.1 General 15.3.2 Push test 15.3.3 Impact test 15.3.4 Drop test 15.3.4.1 HAND-HELD ME EQUIPMENT 15.3.4.2 PORTABLE ME EQUIPMENT
15.3.5 Rough handling test
15.3.6 Mould stress relief test 15.3.7 Environmental influences 15.4 ME EQUIPMENT components and general assembly
15.4.1 Construction of connectors 15.4.2 Temperature and overload control devices
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15.4.2.1 Application
15.4.2.2 Temperature settings 15.4.3 Batteries 15.4.3.1 Housing 15.4.3.2 Connection 15.4.3.3 Protection against overcharging 15.4.3.4 Lithium batteries
15.4.3.5 Excessive current and voltage protection 15.4.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing, prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4.7 devices (see also 8.10.4) 15.4.7.1 Mechanical strength 15.4.7.2 Accidental operation of ME EQUIPMENT 15.4.5 15.4.6 15.4.6.1 15.4.6.2
15.4.7.3 Entry of liquids 15.4.8 Internal wiring of ME EQUIPMENT 15.4.9 Oil containers
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15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS, components and layout MULTIPLE SOCKET-OUTLET
16.9.2.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.9.2.3 Protection of conductors
Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS
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Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction
Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.2.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.2.4 ANAESTHETIC MIXTURE WITH AIR G.1.1 G.1.2 G.1.3 G.2 G.2.1 G.2.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking, ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT, parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT, parts and components thereof General Power supply
G.2.5 G.3 G.3.1 G.3.2 G.3.3 G.3.4 G.3.5 G.4 G.4.1 G.4.2 G.4.3 G.4.4 G.5 G.5.1 G.5.2 G.5.3 G.5.4 G.5.5 G.6 G.6.1 G.6.2
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G.6.3 Temperatures and low-energy circuits G.6.4 Heating elements G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required
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4.1
4.2
Risk Management File 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE
Risk Analysis
Risk Analysis Process
Intended Use
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4.1
4.2
Risk Management File 6 Classification 6.1 General 6.2 Protection against electric shock Protection against harmful ingress of water or 6.3 particulate matter 6.4 6.4 Method(s) of sterilization 6.5 6.6 7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification, marking and documents General USABILITY of the identification, marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable
Risk Analysis
Intended Use
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
7.2.13 7.2.14 7.2.15 7.2.16
22/120
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60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File
Risk Analysis
Intended Use
7.2.17 7.2.18 7.2.19 7.2.20
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
23/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS
Risk Analysis
Intended Use
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
24/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 8.2.2 Connection to an external d.c. power source
Risk Analysis
Intended Use
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
25/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL
Risk Analysis
Intended Use
8.6.3 8.6.4 8.6.5 8.6.6
26/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS
Risk Analysis
Intended Use
27/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords
Risk Analysis
Intended Use
8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5
28/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS
Risk Analysis
Intended Use
29/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD
Risk Analysis
Intended Use
9.7.7 9.7.8 9.8 9.8.1
30/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 9.8.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.3 suspension systems
Risk Analysis
Intended Use
9.8.3.1 General
31/120
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60601-1:2005 Topic
3.6
4.1
4.2
Risk Analysis
Intended Use
11.1.2.2
11.1.3 Measurements
32/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Analysis
Intended Use
11.2.3 11.3 11.4 11.5
33/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output
Risk Analysis
Intended Use
34/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 13.2.1 13.2.2 13.2.3 13.2.4 13.2.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices
Risk Analysis
Intended Use
35/120
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60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File 14.9 Design and implementation 14.10' VERIFICATION
Risk Analysis
Intended Use
36/120
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60601-1:2005 Topic
3.6
4.1
4.2
Risk Analysis
Intended Use
37/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems
Risk Analysis
Intended Use
15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
38/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction
Risk Analysis
Intended Use
39/120
APPENDIX A Clause
60601-1:2005 Topic
3.6
4.1
4.2
Risk Management File G.6.3 Temperatures and low-energy circuits G.6.4 Heating elements G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required
Risk Analysis
Intended Use
40/120
APPENDIX A Clause
60601-1:2005 Topic
4.3 Identification of Hazards
4.4
ISO 14971:2000 Clauses 5
Estimation of Risks
Risk Evaluation
Risk Control
4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE
41/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
7.2.13 7.2.14 7.2.15 7.2.16
42/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
7.2.17 7.2.18 7.2.19 7.2.20
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
43/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
44/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
8.2.2 Connection to an external d.c. power source
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
45/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL
8.6.3 8.6.4 8.6.5 8.6.6
46/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12
47/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords
8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5
48/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS
49/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD
9.7.7 9.7.8 9.8 9.8.1
50/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
9.8.3.1 General
51/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
11.1.2.2
11.1.3 Measurements
52/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
11.2.3 11.3 11.4 11.5
53/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output
54/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
13.2.1 13.2.2 13.2.3 13.2.4 13.2.5
General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices
55/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
56/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
57/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
58/120
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60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction
59/120
APPENDIX A Clause
60601-1:2005 Topic
4.4
Estimation of Risks
Risk Evaluation
Risk Control
60/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
6.2 Risk Control Option Analysis
6.3 Implementation of risk control measures
6.4 Residual risk evaluation
6.5 Risk/Benefit Analysis
Risk Reduction 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE
61/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 6 Classification 6.1 General 6.2 Protection against electric shock Protection against harmful ingress of water or 6.3 particulate matter 6.4 6.4 Method(s) of sterilization 6.5 6.6 7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification, marking and documents General USABILITY of the identification, marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
7.2.13 7.2.14 7.2.15 7.2.16
62/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction
7.2.17 7.2.18 7.2.19 7.2.20
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
63/120
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60601-1:2005 Topic
6.1
Risk Reduction 7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
64/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 8.2.2 Connection to an external d.c. power source
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
65/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL
8.6.3 8.6.4 8.6.5 8.6.6
66/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS
67/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords
8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5
68/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS
69/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD
9.7.7 9.7.8 9.8 9.8.1
70/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 9.8.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.3 suspension systems
9.8.3.1 General
71/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction
11.1.2.2
11.1.3 Measurements
72/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction
11.2.3 11.3 11.4 11.5
73/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output
74/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 13.2.1 13.2.2 13.2.3 13.2.4 13.2.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices
75/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction 14.9 Design and implementation 14.10' VERIFICATION
76/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction
77/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems
15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
78/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction
79/120
APPENDIX A Clause
60601-1:2005 Topic
6.1
Risk Reduction G.6.3 Temperatures and low-energy circuits G.6.4 Heating elements G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required
80/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
7 Residual Risk Evaluation
8 Risk Management Report
9 Production and Post Production Information
Risk arising from risk Completeness of Risk control measures Control 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE
81/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 6 Classification 6.1 General 6.2 Protection against electric shock Protection against harmful ingress of water or 6.3 particulate matter 6.4 6.4 Method(s) of sterilization 6.5 6.6 7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification, marking and documents General USABILITY of the identification, marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
7.2.13 7.2.14 7.2.15 7.2.16
82/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control
7.2.17 7.2.18 7.2.19 7.2.20
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
83/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
84/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 8.2.2 Connection to an external d.c. power source
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
85/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL
8.6.3 8.6.4 8.6.5 8.6.6
86/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS
87/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords
8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5
88/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS
89/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD
9.7.7 9.7.8 9.8 9.8.1
90/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 9.8.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.3 suspension systems
9.8.3.1 General
91/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
11.1.2.2
11.1.3 Measurements
92/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
11.2.3 11.3 11.4 11.5
93/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output
94/120
APPENDIX A Clause
60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 13.2.1 13.2.2 13.2.3 13.2.4 13.2.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices
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60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control 14.9 Design and implementation 14.10' VERIFICATION
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60601-1:2005 Topic
6.6
6.7
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60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems
15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
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60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction
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60601-1:2005 Topic
6.6
6.7
Risk arising from risk Completeness of Risk control measures Control G.6.3 Temperatures and low-energy circuits G.6.4 Heating elements G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required
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60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments
4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.4 EXPECTED SERVICE LIFE Requires a risk management process in accordance with ISO 14971 and that the risks from the device are managed using the manufacturer's process. Affects the compliance criteria for specific tests. Impacts some of the verification testing the manufacturer must conduct. Provides an alternate compliance means of compliance when an equivalent or lower residual level of risk results. Affects the basic safety verification of parts that can contact the patient. Risk management is used to facilitate the considerations of single fault conditions to be applied. Component rating exceptions may be made by the use of risk management. Risk management may be used to determine the need for the use of High-Integrity components.
4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.6 PATIENT 4.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.9 CHARACTERISTICS in ME EQUIPMENT 4.10' Power supply 4.10.1 Source of power for ME EQUIPMENT 4.10.2 4.11 5 5.1 5.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples All parts b) a)
Provides verification testing input.
a)
b), c), d)
Determines accessibility of accuating mechanisms.
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The Usability Engineering Process includes the risk of poor usability.
Risk management may be used to demonstrate that marking is not necessary.
7.2.5 7.2.6 7.2.7 7.2.8 7.2.8.1 7.2.8.2 7.2.9 7.2.10 7.2.11 7.2.12
The risk management file may indicate the need for a specific power supply and require marking for risk control.
7.2.13 7.2.14 7.2.15 7.2.16
The RMF may have considered physiological effects in the risk assessment and may have indicated the need for marking as a risk control measure.
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60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments The risk assessment may include the need for protective packaging and identify marking as a risk control measure.
7.2.17 7.2.18 7.2.19 7.2.20
The risk assessment may include the need for adequately training personnel to change lithium batteries or fuel cells and provide marking and IFU requirements as risk control measures.
The risk assessment may identify any hazardous situations from supply terminal connections.
The risk management file may indicate the need for control marking based on risk assessment. Risk assessment may include risk control measures requiring the use of safety sign(s) to convey a warning, prohibition or mandatory action.
7.5 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.8 7.8.1
b)
a), c), d)
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7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS Risk management provides consideration for which information needs to be provided as hard copy or as marking on the device.
Inspect IFU accordingly.
Risk assessment may indicate the need for risk control measures for removing batteries and for loss of power. Risk assessment may indicate the need for risk control measures for providing IFU advice for patient or operator protection from materials or ingredients.
7.9.2.15 7.9.2.16 7.9.3 7.9.3.1
Environmental protection Reference to the technical description Technical description (see also Table C.6) General Replacement of fuses, POWER SUPPLY CORDS and other parts Circuit diagrams, component part lists, etc. Mains isolation Protection against electrical HAZARDS from ME EQUIPMENT b) a)
Risk assessment may indicate the need for risk control measures for the disposal of waste products, residues and of the MEE and accessories at the end of their useful life and advice for minimizing these risks.
7.9.3.2 7.9.3.3 7.9.3.4 8
Risk assessment may include the need for risk control measures with regard to replacement of components and associated hazards.
8.1 Fundamental rule of protection against electric shock 8.2 Requirements related to power sources 8.2.1 Connection to a separate power source
Provides verification tests input for SFC's when applicable.
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8.2.2 Connection to an external d.c. power source Risk assessment may identify the need for risk control measures for parts (not being applied parts) that can come into contact with the patient and at what level these parts require protection means.
d)
a), b), c)
c)
a), b), d), e)
Risk assessment may reveal that contacts of connectors or fuseholders or lampholders or parts inside an access cover do not require touch leakage current limitation because the probability of contact is low enough.
8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1
Risk assessment and any risk control measures for insulation coatings that provide a means for patient protection may be included in the risk management file.
Risk management may be used to exempt the one means of patient protection separation requirement between unearthed Type B Applied Parts and unearhted conductive accessible parts. Risk management may be used to provide exemption from testing with the straight unjointed test finger because unacceptable risk from contact with corners and edges will not occur.
a), b)
For the situation of an applied part with multiple functions where separate functions are not all defibrillator-proof, the risk assessment and any risk control measures includes consideration for shock hazards because of the lack of separation.
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APPENDIX A Clause
Protective earthing, functional earthing and potential 8.6 equalization of ME Equipment 8.6.1 Applicability of requirements 8.6.2 PROTECTIVE EARTH TERMINAL The risk management file may include the identification of the need for moving parts to be protectively earthed and the connection reliability during the expected service life.
8.6.3 8.6.4 8.6.5 8.6.6
The risk management file may include consideration for the accidental disconnection of the potential equalization conductor.
a)
b)
Risk assessment and any risk control measures for resistance to heat of insulation (other than wire insulation) is included in the risk management file.
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8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12
8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c. Minimum CREEPAGE DISTANCES for two MEANS OF 8.9.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.9.1.15 DEFIBRILLATION-PROOF APPLIED 8.9.2 Application 8.9.3 Spaces filled by insulating compound 8.9.3.1 General Insulating compound forming solid insulation between 8.9.3.2 conductive parts Insulating compound forming a cemented joint with 8.9.3.3 other insulating parts 8.9.3.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.9.4 CLEARANCES 8.10' Components and wiring 8.10.1 Fixing of components The need for securely mounting components is included in the risk management file. The need for securing conductors and connectors and not solder coating stranded conductors to prevent a hazardous situation from detachment is considered in the risk management file.
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APPENDIX A Clause
Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords The risk management file risk assessment and risk control measures may include protection of cables, wiring, cord forms or components from damage by moving parts, friction at sharp corners or edges, assembly or opering or closing access covers.
8.10.5 Mechanical protection of wiring a), b) 8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS, components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection
If the manufacturer omits fuses or over-current releases, the risk management file includes justification for the omission.
Risk management is used to assess, control and consider the residual risk associated with moving parts.
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9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS Risk management may be used for guards and protective measures.
The risk management file includes considerations movable guards that can be opened without the use of a tool. The risk management file includes considerations for protective measures providing protection from moving parts. The risk management file includes considerations for continuous activation controls and the need for emergency stopping devices in regards to moving parts and trapping zones. The risk management file includes consideration for the speed of moving parts and the overtravel after activation to stop movement. Inspect controls for unintended movement hazards. The risk management file includes considerations for overtravel and end stops or other stopping means. The risk management file includes considerations for emergency stopping devices. The risk management file includes considerations for the release of the patient. The risk management file includes considerations for hazards associated with surfaces, corners and edges. Follow the requirements given in clauses 9.4.2 to 9.4.4.
a), b), c)
9.2.2.6 Speed of movement(s) 9.2.3 Other HAZARDS associated with moving parts 9.2.3.1 Unintended movement 9.2.3.2 Overtravel 9.2.4 Emergency stopping devices 9.2.5 Release of PATIENT 9.3 9.4 9.4.1 9.4.2 9.4.2.1 9.4.2.2 9.4.2.3 9.4.2.4 HAZARD associated with surfaces, corners and edges Instability HAZARDS General Instability overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels a), b), e) c), d), f), g), h), i), j), k)
a), b) Equipment with castors or wheels may include a risk assessment and risk control measures for when the equipment is moved or parked.
For mobile equipment weighing over 45 kg, the risk management file includes risk assessment and any risk control measures when passing over a 20 mm high 80 mm wide step.
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Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD a), b), c), d) a), b) Instability in transport from unwanted lateral movement may be included in the risk management file. Instability excluding transport from unwanted lateral movement may be included in the risk management file.
The risk management file includes an assessment and any risk control measures regarding the need for protective means from expelled parts.
Where applicable, the risk management file includes a risk assessment and any risk control measures for protection from acoustic energy and vibration.
Where applicable, the risk management file includes a risk assessment and any risk control measures for protection from infrasound and ultrasound energy.
The risk management file includes considerations for parts subject to pneumatic or hydraulic pressure. Where applicable, the risk management file includes consideration for the necessary pressure rating of parts in both normal and single fault condition. Risk management may include an assessment for leakage from parts under pressure. Where applicable, the risk management file includes consideration for pressure control device performance and operation point. Where applicable, the risk management file includes consideration for pressure relief device operation discharge and characteristics identified herin.
9.7.7 9.7.8 9.8 9.8.1
a), b), c), d), e), f), g), h)
Where applicable, the risk management file includes
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consideration for hazards associated with support systems.
9.8.3.1 General
Where applicable, the risk management file includes consideration for the strength of patient or operator support or suspension systems. Where applicable, the risk management file includes consideration for static forces due to loading from persons. The RMF may be helpful with determination of unacceptable risks caused by dynamic forces due to loading from persons.
a), b)
9.8.3.3 Dynamic forces due to loading from persons 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.4.1 General Use after activation of a MECHANICAL PROTECTIVE 9.8.4.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.8.4.3 activation b) a)
Where applicable, the risk management file includes consideration for mechanical protective devices.
Where applicable, the risk management file includes consideration for mechanical protective device(s) intended for single activation. Where applicable, the risk management file includes consideration for not requiring the use of a mechanical protective device(s).
Where applicable, the risk management file includes considerations for unintended X-radiation. Where applicable, the risk management file includes considerations for alpha, beta, gamma, neutron and other partical radiation. Where applicable, the risk management file includes considerations for microwave radiation.
Where applicable, the risk management file includes considerations for visible electromagnetic radiation other than that produced by lasers and light emitting diodes. Where applicable, the risk management file includes considerations for infrared radiation other than that produced by lasers and light emitting diodes.
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60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments Where applicable, the risk management file includes considerations for ultraviolet radiation other than that produced by lasers and light emitting diodes.
Where applicable, the risk management file includes consideration for the temperature of parts likely to be touched by either unhealthy skin or surface area's greater than 10 % of the total body surface or greater than 10 % of the total head surface. Where applicable, the risk management file includes consideration for the temperature of applied parts for either unhealthy skin or surface area's greater than 10 % of the total body surface or greater than 10 % of the total head surface. Where applicable, the risk management file includes consideration for the temperature and clinical effects from applied parts intended to supply heat to a patient. Where applicable, the risk management file includes consideration for the clinical effects with respect to characteristics such as body surface, maturity of patients, medications being taken or surface pressure when applied part temperature exceed 41 C or are cooled below ambient temperature. The risk management file may include judgements that temperature measurement is not necessary or the use of the test corner is not necessary and the probability of occurrence of contact and of the duration of contact for parts likely to be touched and for applied parts. Any alternative test methods are justified in the risk management file.
11.1.2.2
11.1.3 Measurements
e) is 6.3 only 11.1.4 GUARDS 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.2.2 with OXYGEN RICH ENVIRONMENTS
a), b), c), d)
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60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments The risk management file may provide justification for deviations from worst-case limits (lower oxygen concentrations or less flammable fuel). Determination for the acceptable design configuration that provides an acceptable residual risk of fire in an oxygen rich environment. Risk management may be used for external exhaust outlets and electrical components location in an oxygen rich environment.
11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT a), b) External exhaust outlets for OXYGEN RICH 11.2.2.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2.2.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT 11.2.3 and ME SYSTEMS Constructional requirements for fire ENCLOSURES of 11.3 ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use 11.4 with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in 11.5 conjunction with flammable agents Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME 11.6 EQUIPMENT 11.6.1 General
a), b)
The risk management file may be used to analyze risk for the construction of fire enclosures.
The risk management file includes consideration for the possibility of fire and associated mitigations.
Risk management may include risk assessment and risk control measure for equipment which incorporates a liquid reservoir. Where applicable, the risk management file includes consideration for the type of liquids, volume, duration of spill and location. This is an input for test verifcation.
The risk management file is used to capture the results of multiple cleanings over the expected service life. The risk management file includes risk assessment and risk control measures for parts that are sterilized. The risk management file includes, where applicable, compatibility with substances.
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APPENDIX A Clause
Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output The risk management file includes a risk assessment associated with hazardous output from intentional exceeding of safety limits. The risk management file includes the need for the indication of parameters that are associated with hazardous output. Risk management is used to address the risk of accidental selection of excessive output values when equipment provides both low-intensity and high-intensity outputs. Risk management is used to address the risk associated with incorrect output. The risk management file includes risk assessment and any risk control measures associated with the accuracy of controls. Follow these requirements and those in IEC 60601-1-6. The risk management file includes the need for alarm systems as a risk control measure and addresses any risk associated with the operation or failure of the alarm system.
Risk management is used to address the risk associated with diagnostic X-rays. Risk management is used to address the risk associated with radiotherapy. Risk management is used to address the risk associated with diagnostic or therapeutic radiatio other than diagnostic X-ray and radiotherapy. Risk management is used to address the risk associated with diagnostic or therapeutic acoustic pressure.
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13.2.1 13.2.2 13.2.3 13.2.4 13.2.5
General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices Risk management is used to determine the appropriate test conditions for leakage of liquids.
Risk management can be used to demonstrate that the failure of the PESS does not lead to an unacceptable risk. Thr risk management file includes the documents required from clause 14 application. Thr risk management plan includes PEMS Validation Plan.
Risk Analysis includes hazards associated with PEMS hardware and software aspects including Network/Data Coupling. Validated tools and procedures are selected and identified to implement each risk control measure.
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APPENDIX A Clause
The risk management file includes descriptive data regarding the design environment. Verification of all functions that implement risk control measure, basic safety and essential performance. The risk management file includes all professional relationships of the membes of the PEMS development team and the design team and also a reference to the methods and results of the PEMS Validation.
Risk management addresses the risks associated with the arrangement of controls and indicators. Risk control measures may identify the need for parts to be accessible for inspection, replacement and maintenance.
Risk management is used to identify risk associated with pushing. Risk management is used to identify risks associated with impacts. Risk management may be used to identify risks associated with hand-held equipment drops. Risk management is used to identify risks associated with portable equipment handling. Risk management is used to identify risks associated with mobile equipment cuased by asending step, descending step and door frame shock. Risk management may provide evidence of unaccepatable risk for inspection after mold stress relief testing.
a), b)
Risk management is used to address the risk of electrical, hydraulic, pneumatic and gas connection terminals and connectors.
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APPENDIX A Clause
60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments Risk management is used to address the risk of automatic resetting thermal cut-outs and over-current releases. Risk management is used to address the risk of thermal cutouts that have to be reset by a soldering operation. Risk management is used to address the risk of the failure of thermostat and the need for an over temperature thermal cutout. Risk management is used to address the risk of the loss of function caused by the operation of a thermal cut-out or overcurrent release. Risk management is used to address the risk associated with heating elements making a condutive connection to earth that could result in over-heating.
a) b) 15.4.2.1 Application
c)
d)
e), f), g)
h) 15.4.2.2 Temperature settings 15.4.3 Batteries 15.4.3.1 Housing 15.4.3.2 Connection 15.4.3.3 Protection against overcharging 15.4.3.4 Lithium batteries
Risk management is used to address both battery ventilation and accidental short-circuiting. The risk management file may provide some guidance for the incorrect connection or replacement of batteries. The risk management file may address risks associated with over-charging the batteries. Risk management is used to justify the omission of fuses or over-current releases providing protection from excessive battery current. Risk management is used to address the risks associated with pre-set controls.
b)
a)
Risk management is used to determine the probability of foot switches being used in areas where liquids are likely to be found.
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15.5 15.5.1 15.5.1.1 15.5.1.2 15.5.1.3 15.5.2 15.5.3 16
MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5 Medical electrical systems Risk management is used to determine which configurations constitute the highest risks and which risk control measures are needed in any possible configuration to prevent an unacceptable risk.
16.1 16.2 16.3 16.4 16.5 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.4.1 16.6.4.2 16.7 16.8 16.9 16.9.1 16.9.2 16.9.2.1
16.9.2.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.9.2.3 Protection of conductors Risk management is used to address the risk associated with use of the equipment in electromagnetic environments where it is expected to be used and the equipment's electromagnetic effect on that environment.
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Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1 Introduction Risk management is used to determine the probability of occurrence of ignition from anaesthetic mixtures depending on their concentration, ignition energy or high surface temperatures and the energy of sparking..
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Guidelines For Risk Management in Medical Electrical Equip

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What are the three types of references to ISO 14971 Risk Management requirements mentioned in the document?

What are the three types of references to ISO 14971 Risk Management requirements mentioned in the document?

What are the general principles regarding addressing Risk Management in IEC 60601-1 CB Scheme investigations?

What are the general principles regarding addressing Risk Management in IEC 60601-1 CB Scheme investigations?

GUIDELINES FOR RISK MANAGEMENT IN MEDICAL ELECTRICAL EQUIPMENT See Appendix A 1.

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

7.2.13 7.2.14 7.2.15 7.2.16

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

7.2.17 7.2.18 7.2.19 7.2.20

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

7.8.2 Colours of controls 7.9 ACCOMPANYING DOCUMENTS

7.9.2.15 7.9.2.16 7.9.3 7.9.3.1

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

8.2.2 Connection to an external d.c. power source

8.5.1.1 8.5.1.2 8.5.1.3 8.5.2 8.5.2.1

8.5.2.2 TYPE B APPLIED PARTS

8.5.5.1 Defibrillation protection 8.5.5.2 Energy reduction test

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

8.6.3 8.6.4 8.6.5 8.6.6

8.8.4.1 Mechanical strength and resistance to heat

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

8.10.2 Fixing of wiring 8.10.3 Connections between different parts of ME EQUIPMENT

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

8.10.5 Mechanical protection of wiring

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel

Risk Management Plan

9.2.2.4.3 Movable GUARDS

9.2.2.4.4 Protective measures

9.2.2.5 Continuous activation

3.2 Risk Management Process

3.3 Management Responsibilities

3.4 Qualification of Personnel