AAMI ES60601 1 2021

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ANSI/AAMI ES60601-1:2005 & A1:2012 & A2:2021, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

Published By	Publication Date	Number of Pages
AAMI	2021	442

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Description

This standard includes 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. The second amendment addresses changes to terminology and references since the main document was finalized in 2005 and first amended in 2012.

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PDF Pages	PDF Title
1	ANSI/AAMI ES60601-1:2005 & A1:2012 & A2:2021 (IEC 60601-1:2005, MOD); Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (Consolidated Text; Redline Version)
3	Title page
4	AAMI Standard Copyright information
5	Contents
13	Committee representation
15	Background of ANSI/AAMI adoption of IEC 60601-1:2005 as ES60601-1 and Amendments 1 and 2
17	U.S. (AAMI) deviations from IEC 60601-1:2005
20	Foreword
22	Introduction
24	INTRODUCTION TO AMENDMENT 1 INTRODUCTION TO AMENDMENT 2
25	1 Scope, object and related standards 1.1 * Scope 1.2 Object
26	1.3 * Collateral standards 1.4 * Particular standards 2 * Normative references
31	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
56	4.3 * Essential performance
57	4.4 * Expected service life 4.5 * Equivalent safety for me equipment or me systems * 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
61	4.10.2 Supply mains for me equipment and me systems 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 5.7 * Humidity preconditioning treatment
64	5.8 Sequence of tests 5.9 * Determination of applied parts and accessible parts 5.9.1 Applied parts 5.9.2 Accessible parts 5.9.2.1 * Test finger
66	5.9.2.2 Test hook
68	5.9.2.3 Actuating mechanisms 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 6.6 * Mode of operation
69	7 Me equipment identification, marking and documents 7.1 General 7.1.1 * Usability of the identification, marking and documents 7.1.2 * 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 7.2.3 * Consult accompanying documents
71	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
73	7.2.8.2 Other power sources 7.2.9 IP classification 7.2.10 * Applied parts 7.2.11 Mode of operation 7.2.12 * Fuses 7.2.13 Physiological effects (safety signs 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 7.3.6 Functional earth terminals 7.3.7 Supply terminals
76	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 measure measurement
78	7.5 Safety signs 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 Colours 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 * Colours of indicator lights
81	7.8.2 Colours of controls
82	7.9 Accompanying documents 7.9.1 * General (see also Table C.4) 7.9.2 Instructions for use (see also Table C.5) 7.9.2.1 * General
83	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
84	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 7.9.2.10 Messages
85	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 7.9.2.15 Environmental protection
86	7.9.2.16 Reference to the technical description 7.9.3 Technical description (see also Table C.6) 7.9.3.1 * General
87	7.9.3.2 Replacement of fuses, power supply cords and other parts 7.9.3.3 Circuit diagrams, component part lists, etc. 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
89	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 and applied parts
92	8.4.3 * Me equipment intended to be connected to a power 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 General
94	8.5.1.2 * Means of patient protection (mopp)
95	8.5.1.3 Means of operator protection (moop)
97	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
98	8.5.3 * Maximum mains voltage 8.5.4 * Working voltage
99	8.5.5 Defibrillation-proof applied parts 8.5.5.1 * Defibrillation protection
105	8.5.5.2 Energy reduction test
107	8.6 * Protective earthing, functional earthing and potential equalization of me equipment 8.6.1 * Applicability of requirements 8.6.2 * Protective earth terminal 8.6.3 * Protective earthing of moving parts 8.6.4 Impedance and current-carrying capability
108	8.6.5 Surface coatings 8.6.6 Plugs and sockets
109	8.6.7 * Potential equalization conductor 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
110	8.7.2 * Single fault conditions 8.7.3 * Allowable values
113	8.7.4 Measurements 8.7.4.1 General
128	8.7.4.2 * Measuring supply circuits 8.7.4.3 * Connection to the measuring supply circuit 8.7.4.4 Measuring device (MD)
129	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
130	8.7.4.7 Measurement of the patient leakage current
131	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
132	8.8.2 * Distance through solid insulation or use of thin sheet material
133	8.8.3 * Dielectric strength
135	8.8.4 Insulation other than wire insulation 8.8.4.1 * Mechanical strength and resistance to heat
136	8.8.4.2 Resistance to environmental stress
137	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 or IEC 62368-1 8.9.1.3 creepage distances across glass, mica, ceramic and similar materials
138	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
139	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
140	8.9.1.12 Secondary circuits 8.9.1.13 Peak working voltages above 1 400 V peak or d.c.
141	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
147	8.9.1.16 Conductive surface coatings 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
148	8.9.3.3 Insulating compound forming a cemented joint with other insulating parts 8.9.3.4 Thermal cycling 8.9.4 * Measurement of creepage distances and air clearances
155	8.10 Components and wiring 8.10.1 * Fixing of components 8.10.2 * Fixing of wiring
156	8.10.3 Connections between different parts of me equipment 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
157	8.10.7 * Insulation of internal wiring 8.11 Mains parts, components and layout 8.11.1 Isolation from the supply mains
158	8.11.2 * Multiple socket-outlets 8.11.3 Power supply cords 8.11.3.1 Application 8.11.3.2 Types 8.11.3.3 Cross-sectional area of power supply cord conductors
159	8.11.3.4 * Appliance couplers 8.11.3.5 * Cord anchorage
160	8.11.3.6 * Cord guards 8.11.4 Mains terminal devices 8.11.4.1 * General requirements for mains terminal devices
161	8.11.4.2 Arrangement of mains terminal devices 8.11.4.3 Fixing of mains terminals 8.11.4.4 * Connections to mains terminals
162	8.11.4.5 Accessibility of the connection 8.11.5 * Mains fuses and over-current releases 8.11.6 Internal wiring of the mains part
163	9 * Protection against mechanical hazards of me equipment and me systems 9.1 Mechanical hazards of me equipment 9.2 * Mechanical hazards associated with moving parts 9.2.1 * General 9.2.2 Trapping zone 9.2.2.1 General
164	9.2.2.2 Gaps 9.2.2.3 Safe distances 9.2.2.4 * Guards and protective other risk control measures 9.2.2.4.1 Access to trapping zones 9.2.2.4.2 Fixed guards
165	9.2.2.4.3
166	9.2.2.4.4 Movable guards 9.2.2.4.5 Protective Other risk control measures 9.2.2.5 * Continuous activation
167	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
168	9.2.4 * Emergency stopping devices
169	9.2.5 * Release of patient 9.3 * Mechanical hazard associated with surfaces, corners and edges 9.4 * Instability hazards 9.4.1 General
170	9.4.2 * Instability – overbalance 9.4.2.1 Instability in transport position 9.4.2.2 Instability excluding transport position
171	9.4.2.3 Instability from horizontal and vertical forces 9.4.2.4 * Castors and wheels 9.4.2.4.1 General
172	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
173	9.4.3.2 Instability excluding transport position 9.4.4 Grips and other handling devices
174	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 9.6.2 * Acoustic energy 9.6.2.1 Audible acoustic energy
175	9.6.2.2 Infrasound and ultrasound energy 9.6.3 * Hand-transmitted vibration 9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure 9.7.1 General
176	9.7.2 Pneumatic and hydraulic parts 9.7.3 Maximum pressure Void 9.7.4 Pressure rating of me equipment parts 9.7.5 * Pressure vessels
178	9.7.6 Pressure-control device
179	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
180	9.8.2 * Tensile safety factor
181	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
182	9.8.3.3 * Dynamic forces due to loading from persons
183	9.8.4 * Systems with mechanical protective devices 9.8.4.1 General
184	9.8.4.2 Use after activation of a mechanical protective device 9.8.4.3 Mechanical protective device intended for single activation
185	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
186	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
187	10.4 * Lasers and light emitting diodes (LEDs) 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
189	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
190	11.1.3 * Measurements
191	11.1.4 Guards
192	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
197	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 11.3 * Constructional requirements for fire enclosures of me equipment
200	11.4 * Me equipment and me systems intended for use with flammable anaesthetics 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
201	11.6.2 * Overflow in me equipment 11.6.3 * Spillage on me equipment and me systems
202	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 11.7 Biocompatibility of me equipment and me systems
203	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
204	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
205	12.4.5.4 Other me equipment producing diagnostic or therapeutic radiation 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
207	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 13.2.6 Leakage of liquid
208	13.2.7 Impairment of cooling that could result in a hazard hazardous situation 13.2.8 Locking of moving parts 13.2.9 * Interruption and short circuiting of motor capacitors 13.2.10 * Additional test criteria for motor operated me equipment
209	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 13.2.13 * Overload 13.2.13.1 * General overload test conditions
210	13.2.13.2 Me equipment with heating elements 13.2.13.3 Me equipment with motors
211	13.2.13.4 * Me equipment rated for non-continuous operation
212	14 * Programmable electrical medical systems (pems) 14.1 * General
213	14.2 * Documentation 14.3 * Risk management plan 14.4 * Pems development life-cycle 14.5 * Problem resolution 14.6 Risk management process 14.6.1 * Identification of known and foreseeable Hazards
214	14.6.2 * Risk control 14.7 * Requirement specification 14.8 * Architecture
215	14.9 * Design and implementation 14.10 * Verification 14.11 * Pems validation
216	14.12 * Modification 14.13 * Connection of pems by network/data coupling to other equipment * Pems intended to be incorporated into an IT-network
217	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
218	15.3.2 * Push test
219	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
220	15.3.5 * Rough handling test
221	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
222	15.4.2 Temperature and overload control devices 15.4.2.1 Application
223	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
224	15.4.4 * Indicators 15.4.5 Pre-set controls 15.4.6 Actuating parts of controls of me equipment 15.4.6.1 Fixing, prevention of maladjustment
225	15.4.6.2 Limitation of movement 15.4.7 Cord-connected hand-held and foot-operated control devices (see also 8.10.4) 15.4.7.1 Mechanical strength
226	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 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
227	15.5.1.2 Short-circuit test 15.5.1.3 Overload test
228	15.5.2 * Dielectric strength
229	15.5.3 * Construction of transformers used to provide separation as required by 8.5
230	16 * Me systems 16.1 * General requirements for the me systems
231	16.2 * Accompanying documents of an me system
232	16.3 * Power supply 16.4 Enclosures 16.5 * Separation devices 16.6 * Leakage currents 16.6.1 Touch current
233	16.6.2 Earth leakage current of multiple socket-outlet 16.6.3 * Patient leakage current 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
234	16.8 Interruption of the power supply to parts of an me system 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
235	16.9.2.2 * Protective earth connections in me systems
236	16.9.2.3 Protection of conductors 17 * Electromagnetic compatibility of me equipment and me systems
237	Annex A (informative) General guidance and rationale A.1 General guidance A.2 Safety of me equipment and me systems
238	A.3 Guidance to the third edition
239	A.4 Rationale for particular clauses and subclauses
353	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
354	B.9 Separation of parts 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
355	B.20 Leakage currents and patient auxiliary currents and dielectric strength at steady-state operating temperature B.21 Humidity preconditioning treatment 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
356	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 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
357	Annex C (informative) Guide to marking and labelling 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
358	C.3 Marking of controls and instruments C.4 Accompanying documents, general
359	C.5 Accompanying documents, Instructions for use C.6 Accompanying documents, technical description
360	Annex D (informative) Symbols on marking (see Clause 7)
369	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)
372	Annex F (informative) Suitable measuring supply circuits
375	Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures G.1 Introduction G.1.1 Applicability G.1.2 Industrial equipment and components G.1.3 * Requirements for me equipment
376	G.2 Locations and basic requirements G.2.1 Parts of category apg me equipment G.2.2 Flammable anaesthetic mixture with air G.2.3 Flammable anaesthetic mixture with oxygen or nitrous oxide G.2.4 Me equipment specified for use with flammable anaesthetic mixture with air G.2.5 Me equipment specified for use with flammable anaesthetic mixture with oxygen or nitrous oxide
377	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 G.4 Common requirements for category ap and category apg me equipment G.4.1 Electrical connections
378	G.4.2 Construction details G.4.3 Prevention of electrostatic charges G.4.4 Corona
379	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
383	G.5.4 * External ventilation with internal overpressure G.5.5 Enclosures with restricted breathing
384	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
388	G.6.4 Heating elements
389	G.7 Test apparatus for flammable mixtures
391	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
394	H.3 Software processes A.1.1 Pems development life-cycle A.1.1 Requirements specification A.1.1 Third-party and off-the-shelf (OTS) software
395	A.1.1 Integration A.1.1 Configuration management A.1.1 Modification/change control H.4 Design and implementation
396	H.5 Documentation
398	H.6 Network/data coupling Pems intended to be incorporated into an IT-network H.6.1 General H.6.2 System integration responsibilities
399	H.7 Design considerations for network/data coupling IT-networks H.7.1 Introduction Overview H.7.2 Causes of hazards hazardous situations associated with network/data coupling IT-networks
400	H.7.3 Network classification based on the consequence to the patient Not used A.1.1.1 Consequence to the patient A.1.1.1 Class C network/data coupling (patient vital data, time critical)
401	A.1.1.1 Class B network/data coupling (patient vital data, non-time critical) A.1.1.1 Class A network/data coupling H.7.4 Network/data coupling IT-network parameters
404	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
408	I.2 Examples of application of multiple socket-outlets (mso)
410	Annex J (informative) Survey of insulation paths
414	Annex K (informative) Simplified patient leakage current diagrams
417	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
418	L.3.3 Heat shock L.3.4 Retention of electric strength after bending
419	L.4 Tests during manufacture L.4.1 General L.4.2 Routine testing L.4.3 Sampling tests
420	Annex M (normative) Reduction of pollution degrees
421	Bibliography
426	INDEX OF ABBREVIATIONS AND ACRONYMS
428	INDEX

Additional information

Standard Title	ANSI/AAMI ES60601-1:2005 & A1:2012 & A2:2021, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
Published Code	AAMI
Publication Date	2021
Pages Count	442

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