AAMI ES60601 1 2005 RA 2012 A1 2016
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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD) – Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
| Published By | Publication Date | Number of Pages |
| AAMI | 2005 | 428 |
Baseline of requirements for the basic safety and essential performance of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. Also contains certain requirements for reliable operation to ensure safety. This standard can also be applied to equipment used for compensation or alleviation of disease, injury, or disability. This consolidates the original text of ANSI/AAMI ES60601-1:2005 and its amendments
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text), Medical electrical equipment—Part 1: General requirements for basic safety and essential performance |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | CONTENTS |
| 14 | Glossary of equivalent standards |
| 15 | Committee representation |
| 16 | Background of ANSI/AAMI adoption of IEC 60601-1:2005 and Amendment 1 |
| 17 | AAMI deviations from IEC 60601-1:2005 |
| 20 | FOREWORD |
| 23 | INTRODUCTION |
| 25 | INTRODUCTION TO THE AMENDMENT |
| 27 | 1 Scope, object and related standards 1.1 * Scope 1.2 Object |
| 28 | 1.3 * Collateral standards 1.4 * Particular standards 2 * Normative references |
| 32 | 3 * Terminology and definitions |
| 53 | 4 General requirements 4.1 * Conditions for application to me equipment or me systems 4.2 * Risk management process for me equipment or me systems 4.2.1 Introduction to RISK MANAGEMENT |
| 54 | 4.2.2 General requirement for RISK MANAGEMENT |
| 55 | 4.2.3 Evaluating RISK 4.2.3.1 HAZARDS identified in the IEC 60601-series |
| 56 | 4.2.3.2 HAZARDS not identified in the IEC 60601 series 4.3 * Essential performance |
| 57 | 4.4 * Expected service life 4.5 * Alternative risk control measures or test methods for me equipment or me systems 4.6 * Me equipment or me system parts that contact the patient 4.7 * Single fault condition for me equipment |
| 58 | 4.8 * Components of me equipment |
| 59 | 4.9 * Use of components with high-integrity characteristics in me equipment |
| 60 | 4.10 * Power supply 4.10.1 Source of power for me equipment 4.10.2 Supply mains for me equipment and me systems |
| 61 | 4.11 Power input |
| 62 | 5 * General requirements for testing me equipment 5.1 * Type tests 5.2 * Number of samples 5.3 Ambient temperature, humidity, atmospheric pressure 5.4 Other conditions |
| 63 | 5.5 Supply voltages, type of current, nature of supply, frequency 5.6 Repairs and modifications |
| 64 | 5.7 * Humidity preconditioning treatment 5.8 Sequence of tests 5.9 * Determination of applied parts and accessible parts 5.9.1 Applied parts |
| 65 | 5.9.2 Accessible parts 5.9.2.1 * Test finger |
| 67 | 5.9.2.2 Test hook 5.9.2.3 Actuating mechanisms |
| 68 | 6 * Classification of me equipment and me systems 6.1 General 6.2 * Protection against electric shock 6.3 * Protection against harmful ingress of water or particulate matter 6.4 Method(s) of sterilization 6.5 Suitability for use in an oxygen rich environment |
| 69 | 6.6 * Mode of operation 7 Me equipment identification, marking and documents 7.1 General 7.1.1 * Usability of the identification, marking and documents 7.1.2 See 12.2.* Legibility of markings 7.1.3 * Durability of markings |
| 70 | 7.2 Marking on the outside of me equipment or me equipment parts (see also Table C.1) 7.2.1 Minimum requirements for marking on me equipment and on interchangeable parts 7.2.2 * Identification |
| 71 | 7.2.3 * Consult accompanying documents 7.2.4 * Accessories 7.2.5 Me equipment intended to receive power from other equipment 7.2.6 Connection to the supply mains |
| 72 | 7.2.7 Electrical input power from the supply mains 7.2.8 Output connectors 7.2.8.1 Mains power output 7.2.8.2 Other power sources 7.2.9 IP classification |
| 73 | 7.2.10 * Applied parts 7.2.11 Mode of operation 7.2.12 * Fuses 7.2.13 Physiological effects (safety signs and warning statements) |
| 74 | 7.2.14 High voltage terminal devices 7.2.15 Cooling conditions 7.2.16 Mechanical stability 7.2.17 Protective packaging 7.2.18 External pressure source 7.2.19 Functional earth terminals 7.2.20 Removable protective means |
| 75 | 7.3 Marking on the inside of me equipment or me equipment parts (see also Table C.2) 7.3.1 Heating elements or lampholders 7.3.2 * High voltage parts 7.3.3 Batteries 7.3.4 * Fuses, thermal cut-outs and over-current releases 7.3.5 * Protective earth terminals |
| 76 | 7.3.6 Functional earth terminals 7.3.7 Supply terminals 7.3.8 Temperature of supply terminals 7.4 Marking of controls and instruments (see also Table C.3) 7.4.1 * Power switches |
| 77 | 7.4.2 * Control devices 7.4.3 Units of measuremeasurement |
| 78 | 7.5 Safety signs |
| 79 | 7.6 Symbols 7.6.1 Explanation of symbols 7.6.2 Symbols from Annex D 7.6.3 Symbols for controls and performance 7.7 Colors of the insulation of conductors 7.7.1 Protective earth conductor 7.7.2 Protective earth connections 7.7.3 Green and yellow insulation |
| 80 | 7.7.4 Neutral conductor 7.7.5 power supply cord conductors 7.8 * Indicator lights and controls 7.8.1 Colors of indicator lights 7.8.2 Colors of controls 7.9 Accompanying documents 7.9.1 * General (see also Table C.4) |
| 81 | 7.9.2 Instructions for use (see also Table C.5) 7.9.2.1 * General |
| 82 | 7.9.2.2 * Warning and safety notices 7.9.2.3 Me equipment specified for connection to a separate power supply 7.9.2.4 Electrical power source |
| 83 | 7.9.2.5 Me equipment description 7.9.2.6 * Installation 7.9.2.7 * Isolation from the supply mains 7.9.2.8 Start-up procedure 7.9.2.9 Operating instructions |
| 84 | 7.9.2.10 Messages 7.9.2.11 Shutdown procedure 7.9.2.12 Cleaning, disinfection and sterilization 7.9.2.13 Maintenance 7.9.2.14 Accessories, supplementary equipment, used material |
| 85 | 7.9.2.15 Environmental protection 7.9.2.16 Reference to the technical description 7.9.2.17 ME EQUIPMENT emitting radiation 7.9.2.18 ME EQUIPMENT and ACCESSORIES supplied sterile 7.9.2.19* Unique version identifier 7.9.3 Technical description (see also Table C.6) 7.9.3.1 * General |
| 86 | 7.9.3.2 Replacement of fuses, power supply cords and other parts 7.9.3.3 Circuit diagrams, component part lists, etc. |
| 87 | 7.9.3.4 * Mains isolation 8 * Protection against electrical hazards from me equipment 8.1 Fundamental rule of protection against electric shock |
| 88 | 8.2 Requirements related to power sources 8.2.1 Connection to a separate power source 8.2.2 Connection to an external d.c. power source 8.3 Classification of applied parts |
| 89 | 8.4 Limitation of voltage, current or energy 8.4.1 * Patient connections intended to deliver current 8.4.2 Accessible parts and applied parts |
| 91 | 8.4.3 * Me equipment intended to be connected to a power source by a plug 8.4.4 * Internal capacitive circuits |
| 92 | 8.5 Separation of parts 8.5.1 * Means of protection (mop) 8.5.1.1 General 8.5.1.2 * Means of patient protection (mopp) 8.5.1.3 Means of operator protection (moop) |
| 94 | 8.5.2 Separation of patient connections 8.5.2.1 * F-type applied parts 8.5.2.2 * Type b applied parts 8.5.2.3 * Patient leads or patient cables |
| 95 | 8.5.3 * Maximum mains voltage 8.5.4 * Working voltage |
| 96 | 8.5.5 Defibrillation-proof applied parts 8.5.5.1 * Defibrillation protection |
| 99 | 8.5.5.2 Energy reduction test |
| 100 | 8.6 * Protective earthing, functional earthing and potential equalization of me equipment 8.6.1 * Applicability of requirements |
| 101 | 8.6.2 * Protective earth terminal 8.6.3 * Protective earthing of moving parts 8.6.4 Impedance and current-carrying capability |
| 102 | 8.6.5 Surface coatings 8.6.6 Plugs and sockets 8.6.7 * Potential equalization conductor |
| 103 | 8.6.8 Functional earth terminal 8.6.9 * Class ii me equipment 8.7 Leakage currents and patient auxiliary currents 8.7.1 General requirements |
| 104 | 8.7.2 * Single fault conditions 8.7.3 * Allowable values |
| 107 | 8.7.4 Measurements 8.7.4.1 General |
| 117 | 8.7.4.2 * Measuring supply circuits 8.7.4.3 * Connection to the measuring supply circuit 8.7.4.4 Measuring device (MD) |
| 118 | 8.7.4.5 * Measurement of the earth leakage current and current in functional earth connection 8.7.4.6 * Measurement of the touch current |
| 119 | 8.7.4.7 Measurement of the patient leakage current |
| 120 | 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 |
| 121 | 8.8.2 * Distance through solid insulation or use of thin sheet material |
| 122 | 8.8.3 * Dielectric strength |
| 125 | 8.8.4 Insulation other than wire insulation 8.8.4.1 * Mechanical strength and resistance to heat 8.8.4.2 Resistance to environmental stress |
| 126 | 8.9 * Creepage distances and air clearances 8.9.1 * Values 8.9.1.1 General 8.9.1.2 Creepage distances and air clearances complying with IEC 60950-1 8.9.1.3 creepage distances across glass, mica, ceramic and similar materials |
| 127 | 8.9.1.4 Minimum creepage distance 8.9.1.5 Me equipment rated for high altitudes 8.9.1.6 * Interpolation 8.9.1.7 Material groups classification |
| 128 | 8.9.1.8 Pollution degree classification 8.9.1.9 Overvoltage category classification 8.9.1.10 Air clearance for mains parts 8.9.1.11 Supply mains overvoltage |
| 129 | 8.9.1.12 Secondary circuits 8.9.1.13 Peak working voltages above 1 400 V peak or d.c. |
| 130 | 8.9.1.14 Minimum creepage distances for two means of operator protection 8.9.1.15 * Creepage distances and air clearances for defibrillation-proof applied parts |
| 136 | 8.9.2 * Application 8.9.3 * Spaces filled by insulating compound 8.9.3.1 General 8.9.3.2 Insulating compound forming solid insulation between conductive parts 8.9.3.3 Insulating compound forming a cemented joint with other insulating parts |
| 137 | 8.9.3.4 Thermal cycling 8.9.4 * Measurement of creepage distances and air clearances |
| 142 | 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 |
| 143 | 8.10.4 * Cord-connected hand-held parts and cord-connected foot-operated control devices (see also 15.4.7) 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords 8.10.5 * Mechanical protection of wiring 8.10.6 Guiding rollers for insulated conductors 8.10.7 * Insulation of internal wiring |
| 144 | 8.11 Mains parts, components and layout 8.11.1 Isolation from the supply mains |
| 145 | 8.11.2 * Multiple socket-outlets 8.11.3 Power supply cords 8.11.3.1 Application |
| 146 | 8.11.3.2 Types 8.11.3.3 Cross-sectional area of power supply cord conductors 8.11.3.4 * Appliance couplers |
| 147 | 8.11.3.5 * Cord anchorage |
| 148 | 8.11.3.6 * Cord guards 8.11.4 Mains terminal devices 8.11.4.1 * General requirements for mains terminal devices 8.11.4.2 Arrangement of mains terminal devices |
| 149 | 8.11.4.3 Fixing of mains terminals 8.11.4.4 * Connections to mains terminals 8.11.4.5 Accessibility of the connection 8.11.5 * Mains fuses and over-current releases |
| 150 | 8.11.6 Internal wiring of the mains part 9 * Protection against mechanical hazards of me equipment and me systems 9.1 Mechanical hazards of me equipment |
| 151 | 9.2 * Mechanical hazards associated with moving parts 9.2.1 * General 9.2.2 Trapping zone 9.2.2.1 General |
| 152 | 9.2.2.2 Gaps 9.2.2.3 Safe distances 9.2.2.4 * Guards and protectiveother risk control measures 9.2.2.4.1 Access to trapping zones 9.2.2.4.2 Fixed guards |
| 154 | 9.2.2.4.3 Movable guards 9.2.2.4.4 Other risk control measures 9.2.2.5 * Continuous activation |
| 155 | 9.2.2.6 * Speed of movement(s) 9.2.3 * Other mechanical hazards associated with moving parts 9.2.3.1 Unintended movement 9.2.3.2 Overtravel end stops |
| 156 | 9.2.4 * Emergency stopping devices |
| 157 | 9.2.5 * Release of patient 9.3 * Mechanical hazard associated with surfaces, corners and edges 9.4 * Instability hazards 9.4.1 General |
| 158 | 9.4.2 * Instability – overbalance 9.4.2.1 Instability in transport position 9.4.2.2 Instability excluding transport position |
| 159 | 9.4.2.3 Instability from horizontal and vertical forces 9.4.2.4 * Castors and wheels 9.4.2.4.1 General |
| 160 | 9.4.2.4.2 Force for propulsion 9.4.2.4.3 * Movement over a threshold 9.4.3 * Instability from unwanted lateral movement (including sliding) 9.4.3.1 Instability in transport position |
| 161 | 9.4.3.2 Instability excluding transport position 9.4.4 Grips and other handling devices |
| 162 | 9.5 * Expelled parts hazard 9.5.1 Protective means 9.5.2 Cathode ray tubes 9.6 Acoustic energy (including infra- and ultrasound) and vibration 9.6.1 * General |
| 163 | 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 |
| 164 | 9.7 * Pressure vessels and parts subject to pneumatic and 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 |
| 165 | 9.7.5 * Pressure vessels 9.7.6 Pressure-control device |
| 166 | 9.7.7 Pressure-relief device 9.7.8 Rated maximum supply pressure 9.8 * Mechanical hazards associated with support systems 9.8.1 General |
| 167 | 9.8.2 * Tensile safety factor |
| 169 | 9.8.3 * Strength of patient or operator support or suspension systems 9.8.3.1 General 9.8.3.2 * Static forces due to loading from persons |
| 170 | 9.8.3.3 * Dynamic forces due to loading from persons |
| 171 | 9.8.4 * Systems with mechanical protective devices 9.8.4.1 General |
| 172 | 9.8.4.2 Use after activation of a mechanical protective device 9.8.4.3 Mechanical protective device intended for single activation |
| 173 | 9.8.5 Systems without mechanical protective devices 10 * Protection against unwanted and excessive radiation hazards 10.1 X-Radiation 10.1.1 * Me equipment not intended to produce diagnostic or therapeutic X-radiation |
| 174 | 10.1.2 Me equipment intended to produce diagnostic or therapeutic X-radiation 10.2 Alpha, beta, gamma, neutron and other particle radiation 10.3 Microwave radiation |
| 175 | 10.4 * Lasers 10.5 Other visible electromagnetic radiation 10.6 Infrared radiation 10.7 Ultraviolet radiation 11 Protection against excessive temperatures and other hazards 11.1 * Excessive temperatures in me equipment 11.1.1 * Maximum temperature during normal use |
| 177 | 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 |
| 179 | 11.1.4 Guards |
| 180 | 11.2 * Fire prevention 11.2.1 * Strength and rigidity required to prevent fire in me equipment 11.2.2 * Me equipment and me systems used in conjunction with oxygen rich environments 11.2.2.1 Risk of fire in an oxygen rich environment |
| 184 | 11.2.2.2 * External exhaust outlets for oxygen rich environment 11.2.2.3 Electrical connections in oxygen rich environments 11.2.3 Single fault conditions related to oxygen rich environments in conjunction with me equipment and me systems |
| 185 | 11.3 * Constructional requirements for fire enclosures of me equipment |
| 187 | 11.4 * Me equipment and me systems intended for use with flammable anesthetics 11.5 * Me equipment and me systems intended for use in conjunction with flammable agents 11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the me equipment 11.6.1 General |
| 188 | 11.6.2 * Overflow in me equipment 11.6.3 * Spillage on me equipment and me systems |
| 189 | 11.6.4 * Leakage 11.6.5 * Ingress of water or particulate matter into me equipment and me systems 11.6.6 Cleaning and disinfection of me equipment and me systems 11.6.7 Sterilization of me equipment and me systems 11.6.8 * Compatibility with substances used with the me equipment |
| 190 | 11.7 Biocompatibility of me equipment and me systems 11.8 * Interruption of the power supply / supply mains to me equipment 12 * Accuracy of controls and instruments and protection against hazardous outputs 12.1 Accuracy of controls and instruments 12.2 Usability of me equipment 12.3 Alarm systems 12.4 Protection against hazardous output 12.4.1 * Intentional exceeding of safety limits |
| 191 | 12.4.2 Indication 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 12.4.5.4 Other me equipment producing diagnostic or therapeutic radiation |
| 192 | 12.4.6 Diagnostic or therapeutic acoustic pressure 13 * Hazardous situations and fault conditions for me equipment 13.1 Specific hazardous situations 13.1.1 * General 13.1.2 * Emissions, deformation of enclosure or exceeding maximum temperature |
| 193 | 13.1.3 Exceeding leakage current or voltage limits 13.1.4 Specific mechanical hazards 13.2 Single fault conditions 13.2.1 General 13.2.2 Electrical single fault condition 13.2.3 Overheating of transformers in me equipment 13.2.4 Failure of thermostats 13.2.5 Failure of temperature limiting devices |
| 194 | 13.2.6 Leakage of liquid 13.2.7 Impairment of cooling that could result in a hazardous situation 13.2.8 Locking of moving parts 13.2.9 * Interruption and short circuiting of motor capacitors |
| 195 | 13.2.10 * Additional test criteria for motor operated me equipment 13.2.11 Failures of components in me equipment used in conjunction with oxygen rich environments 13.2.12 Failure of parts that might result in a mechanical hazard |
| 196 | 13.2.13 * Overload 13.2.13.1 * General overload test conditions 13.2.13.2 Me equipment with heating elements |
| 197 | 13.2.13.3 Me equipment with motors |
| 198 | 13.2.13.4 * Me equipment rated for non-continuous operation |
| 199 | 14 * Programmable electrical medical systems (pems) 14.1 * General 14.2 * Documentation 14.3 * Risk management plan 14.4 * Pems development life-cycle |
| 200 | 14.5 * Problem resolution 14.6 Risk management process 14.6.1 * Identification of known and foreseeable Hazards |
| 201 | 14.6.2 * Risk control 14.7 * Requirement specification 14.8 * Architecture 14.9 * Design and implementation |
| 202 | 14.10 * Verification 14.11 * Pems validation 14.12 * Modification |
| 203 | 14.13 * Pems intended to be incorporated into an IT-network |
| 204 | 15 Construction of me equipment 15.1 * Arrangements of controls and indicators of me equipment 15.2 * Serviceability 15.3 Mechanical strength 15.3.1 General |
| 205 | 15.3.2 * Push test 15.3.3 * Impact test |
| 206 | 15.3.4 * Drop test 15.3.4.1 Hand-held me equipment 15.3.4.2 * Portable me equipment |
| 207 | 15.3.5 * Rough handling test 15.3.6 * Mold stress relief test |
| 208 | 15.3.7 * Environmental influences 15.4 Me equipment components and general assembly 15.4.1 Construction of connectors |
| 209 | 15.4.2 Temperature and overload control devices 15.4.2.1 Application |
| 210 | 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 |
| 211 | 15.4.3.5 * Excessive current and voltage protection 15.4.4 * Indicators 15.4.5 Pre-set controls |
| 212 | 15.4.6 Actuating parts of controls of me equipment 15.4.6.1 Fixing, prevention of maladjustment 15.4.6.2 Limitation of movement |
| 213 | 15.4.7 Cord-connected hand-held and foot-operated control devices (see also 8.10.4) 15.4.7.1 Mechanical strength 15.4.7.2 Accidental operation of me equipment 15.4.7.3 * Entry of liquids 15.4.8 Internal wiring of me equipment 15.4.9 Oil containers |
| 214 | 15.5 * Mains supply transformers of me equipment and transformers providing separation in accordance with 8.5 15.5.1 Overheating 15.5.1.1 * Transformers |
| 215 | 15.5.1.2 Short-circuit test 15.5.1.3 Overload test |
| 216 | 15.5.2 * Dielectric strength |
| 217 | 15.5.3 * Construction of transformers used to provide separation as required by 8.5 |
| 218 | 16 * Me systems 16.1 * General requirements for the me systems 16.2 * Accompanying documents of an me system |
| 219 | 16.3 * Power supply |
| 220 | 16.4 Enclosures 16.5 * Separation devices 16.6 * Leakage currents 16.6.1 Touch current 16.6.2 Earth leakage current of multiple socket-outlet 16.6.3 * Patient leakage current |
| 221 | 16.6.4 Measurements 16.6.4.1 General conditions for me systems 16.6.4.2 Connection of the me system to the measuring supply circuit 16.7 * Protection against mechanical hazards 16.8 Interruption of the power supply to parts of an me system |
| 222 | 16.9 Me system connections and wiring 16.9.1 Connection terminals and connectors 16.9.2 Mains parts, components and layout 16.9.2.1 * Multiple socket-outlet |
| 223 | 16.9.2.2 * Protective earth connections in me systems |
| 224 | 16.9.2.3 Protection of conductors 17 * Electromagnetic compatibility of me equipment and me systems |
| 225 | Annex A (informative) General guidance and rationale A.1 General guidance A.2 Safety of me equipment and me systems |
| 226 | A.3 Guidance to the third edition |
| 227 | A.4 Rationale for particular clauses and subclauses |
| 341 | Annex B (informative) Sequence of testing B.1 General B.2 Risk management process for me equipment or me systems and essential performance B.3 General requirements B.4 Classification of me equipment and me systems B.5 Determination of applied parts and accessible parts B.6 Me equipment identification, marking and documents B.7 Energy consumption (power input) B.8 Limitation of voltage, current or energy B.9 Separation of parts |
| 342 | B.10 Creepage distances and air clearances B.11 Hazards associated with moving parts B.12 Hazard associated with surfaces, corners and edges B.13 Serviceability B.14 Accuracy of controls and instruments and protection against hazardous outputs B.15 Instability hazards B.16 Noise, vibration and acoustic energy B.17 Interruption of the power supply / supply mains to me equipment B.18 Protective earthing, functional earthing and potential equalization of me equipment B.19 Excessive temperatures in me equipment B.20 Leakage currents and patient auxiliary currents atand dielectric strength at steady-state operating temperature B.21 Humidity preconditioning treatment |
| 343 | B.22 Dielectric strength (cold condition) Leakage currents and patient auxiliary currents and dielectric strength after humidity preconditioning at ambient temperature in the laboratory B.23 Defibrillation protection B.24 Expelled parts hazard B.25 Pressure vessels and parts subject to pneumatic and hydraulic pressure B.26 Hazards associated with support systems B.27 Mechanical strength B.28 Hazardous situations and fault conditions B.29 Mains supply transformers of me equipment and transformers providing separation in accordance with 8.5 B.30 Me equipment components and general assembly B.31 Mains parts, components and layout B.32 Insulation other than wire insulation B.33 Fire prevention and constructional requirements for fire enclosures of me equipment |
| 344 | B.34 Overflow, spillage, leakage, ingress of water, cleaning, disinfection, sterilization and compatibility with substances used with the me equipment B.35 Category ap and category apg me equipment B.36 Verification of markings |
| 345 | Annex C (informative) Guide to marking and labeling requirements for me equipment and me systems C.1 Marking on the outside of me equipment, me systems or their parts C.2 Marking on the inside of me equipment, me systems or their parts |
| 346 | C.3 Marking of controls and instruments C.4 Accompanying documents, general |
| 347 | C.5 Accompanying documents, Instructions for use C.6 Accompanying documents, technical description |
| 348 | Annex D (informative) Symbols on marking (see Clause 7) |
| 357 | Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current (see 8.7) |
| 360 | Annex F (informative) Suitable measuring supply circuits |
| 363 | Annex G (normative) Protection against hazards of ignition of flammable anesthetic mixtures G.1 Introduction G.1.1 Applicability G.1.2 Industrial equipment and components G.1.3 * Requirements for me equipment |
| 364 | G.2 Locations and basic requirements G.2.1 Parts of category apg me equipment G.2.2 Flammable anesthetic mixture with air G.2.3 Flammable anesthetic mixture with oxygen or nitrous oxide G.2.4 Me equipment specified for use with flammable anesthetic mixture with air |
| 365 | G.2.5 Me equipment specified for use with flammable anesthetic mixture with oxygen or nitrous oxide G.3 Marking, accompanying documents G.3.1 Category apg marking G.3.2 Category ap marking G.3.3 Placement of markings G.3.4 Accompanying documents G.3.5 Marking when parts of me equipment are category ap or category apg |
| 366 | G.4 Common requirements for category ap and category apg me equipment G.4.1 Electrical connections G.4.2 Construction details G.4.3 Prevention of electrostatic charges |
| 367 | G.4.4 Corona G.5 Requirements and tests for category ap me equipment, parts and components thereof G.5.1 General G.5.2 Temperature limits G.5.3 * Low-energy circuits |
| 371 | G.5.4 * External ventilation with internal overpressure G.5.5 Enclosures with restricted breathing |
| 372 | G.6 Requirements and tests for category apg me equipment, parts and components thereof G.6.1 General G.6.2 * Power supply G.6.3 * Temperatures and low-energy circuits |
| 376 | G.6.4 Heating elements G.7 Test apparatus for flammable mixtures |
| 378 | Annex H (informative) Pems structure, pems development life-cycle and documentation H.1 Examples for pems/pess structures H.2 Pems development life-cycle model |
| 381 | H.3 Software processes H.3.1 Pems development life-cycle H.3.2 Requirements specification H.3.3 Third-party and off-the-shelf (OTS) software |
| 382 | H.3.4 Integration H.3.5 Configuration management H.3.6 Modification/change control H.4 Design and implementation |
| 383 | H.5 Documentation |
| 385 | H.6 Network/data coupling Pems intended to be incorporated into an IT-network H.6.1 General H.6.2 System integration responsibilities |
| 386 | H.7 Design considerations for IT-networks H.7.1 Overview H.7.2 Causes of hazardous situations associated with IT-networks |
| 387 | H.7.3 Network classification based on the consequence to the patient Not used H.7.3.1 Consequence to the patient H.7.3.2 Class C network/data coupling (patient vital data, time critical) |
| 388 | H.7.3.3 Class B network/data coupling (patient vital data, non-time critical) H.7.3.4 Class A network/data coupling H.7.4 IT-network parameters |
| 391 | Annex I (informative) Me systems aspects I.1 Combinations of me equipment and non-me equipment I.1.1 Introduction I.1.2 Localities in a medical environment I.1.3 Basic principles I.1.4 Examples of me systems |
| 395 | I.2 Examples of application of multiple socket-outlets (mso) |
| 397 | Annex J (informative) Survey of insulation paths |
| 400 | Annex K (informative) Simplified patient leakage current diagrams |
| 403 | Annex L (normative) Insulated winding wires for use without interleaved insulation L.1 Introduction L.2 Wire construction L.3 Type test L.3.1 Dielectric strength L.3.2 Flexibility and adherence |
| 404 | L.3.3 Heat shock L.3.4 Retention of electric strength after bending |
| 405 | L.4 Tests during manufacture L.4.1 General L.4.2 Routine testing L.4.3 Sampling tests |
| 406 | Annex M (normative) Reduction of pollution degrees |
| 407 | Bibliography |
| 411 | INDEX OF ABBREVIATIONS AND ACRONYMS |
| 413 | INDEX |
