1 Scope, object and related standards
1.1 * Scope
1.3 * Collateral standards
1.4 * Particular standards
2 * Normative references
3 * Terminology and definitions
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
4.3 * Essential performance
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
4.8 * Components of me equipment
4.9 * Use of components with high-integrity characteristics in me equipment
4.10 * Power supply
4.11 Power input
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
5.5 Supply voltages, type of current, nature of supply, frequency
5.6 Repairs and modifications
5.7 * Humidity preconditioning treatment
5.8 Sequence of tests
5.9 * Determination of applied parts and accessible parts
6 * Classification of me equipment and me systems
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
7 Me?equipment identification, marking and documents
7.2 Marking on the outside of me?equipment or me?equipment parts (see also Table C.1)
7.3 Marking on the inside of me?equipment or me?equipment parts (see also Table C.2)
7.4 Marking of controls and instruments (see also Table C.3)
7.5 Safety signs
7.7 Colours of the insulation of conductors
7.8 * Indicator lights and controls
7.9 Accompanying documents
8 * Protection against electrical hazards
from me equipment
8.1 Fundamental rule of protection against electric shock
8.2 Requirements related to power sources
8.3 Classification of applied parts
8.4 Limitation of voltage, current or energy
8.5 Separation of parts
8.6 * Protective earthing, functional earthing and potential equalization of me equipment
8.7 Leakage currents and patient auxiliary currents
8.9 * Creepage distances and air clearances
8.10 Components and wiring
8.11 Mains parts, components and layout
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
9.3 * Mechanical hazard associated with surfaces, corners and edges
9.4 * Instability hazards
9.5 * Expelled parts hazard
9.6 Acoustic energy (including infra- and ultrasound) and vibration
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure
9.8 * Mechanical hazards associated with support systems
10 * Protection against unwanted and excessive radiation hazards
10.2 Alpha, beta, gamma, neutron and other particle radiation
10.3 Microwave radiation
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
11.2 * ?Fire prevention
11.3 * ?Constructional requirements for fire enclosures of me?equipment
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, disin...
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
13 * Hazardous situations and fault conditions for me equipment
13.1 Specific hazardous situations
13.2 Single fault conditions
14 * Programmable electrical medical systems (pems)
14.1 * General
14.2 * Documentation
14.3 * Risk management plan
14.4 * Pems development life-cycle
14.5 * Problem resolution
14.6 Risk management process
14.7 * Requirement specification
14.8 * Architecture
14.9 * Design and implementation
14.10 * Verification
14.11 * Pems validation
14.12 * Modification
14.13 * Pems intended to be incorporated into an IT-network
15 Construction of me?equipment
15.1 * Arrangements of controls and indicators of me equipment
15.2 * Serviceability
15.3 Mechanical strength
15.4 Me?equipment components and general assembly
15.5 * Mains supply transformers of me equipment and transformers providing separation in...
16 * Me systems
16.1 * General requirements for the me systems
16.2 * Accompanying documents of an me system
16.3 * Power supply
16.5 * Separation devices
16.6 * Leakage currents
16.7 * Protection against mechanical hazards
16.8 Interruption of the power supply to parts of an me?system
16.9 Me?system connections and wiring
17 * Electromagnetic compatibility
of me equipment and me systems
Annex A (informative) General guidance and rationale
Annex B (informative) Sequence of testing
Annex C (informative) Guide to marking and labelling requirements for me equipment and me...
Annex D (informative) Symbols on marking
Annex E (informative) Examples of the connection of the measuring device (MD) for measure...
Annex F (informative) Suitable measuring supply circuits
Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtu...
Annex H (informative) Pems structure, pems development life-cycle and documentation
Annex I (informative) Me systems aspects
Annex J (informative) Survey of insulation paths
Annex K (informative) Simplified patient leakage current diagrams
Annex L (normative) Insulated winding wires for use without interleaved insulation
Annex M (normative) Reduction of pollution degrees
INDEX OF ABBREVIATIONS AND ACRONYMS
Figure 1 – Detachable mains connection
Figure 2 – Example of the defined terminals and conductors
Figure 3 – Example of a class i me?equipment
Figure 4 – Example of a metal-enclosed class ii me?equipment
Figure 5 – Schematic flow chart for component qualification
Figure 6 – Standard test finger
Figure 7 – Test hook
Figure 8 – Test pin
Figure 9 – Application of test voltage to bridged patient connectionsfor defibrillation-p...
Figure 10 – Application of test voltage to individual patient connections fordefibrillati...
Figure 11 – Application of test voltage to test the delivered defibrillation energy
Figure 12 – Example of a measuring device and its frequency characteristics
Figure 13 ? Measuring circuit for earth leakage current of class i me equipment, with or ...
Figure 14 ? Measuring circuit for touch current
Figure 15 ? Measuring circuit for patient leakage current from thepatient connection to e...
Figure 16 ? Measuring circuit for patient leakage current via the patient connection(s) o...
Figure 17 ? Measuring circuit for patient leakage current from patient connection(s) to e...
Figure 18 ? Measuring circuit for patient leakage current from patient connection(s) to e...
Figure 19 ? Measuring circuit for patient auxiliary current
Figure 20 – Measuring circuit for the total patient leakage current with all patient conn...
Figure 21 – Ball-pressure test apparatus
Figure 22 – Creepage distance and air clearance – Example 1
Figure 23 – Creepage distance and air clearance – Example 2
Figure 24 – Creepage distance and air clearance – Example 3
Figure 25 – Creepage distance and air clearance – Example 4
Figure 26 – Creepage distance and air clearance – Example 5
Figure 27 – Creepage distance and air clearance – Example 6
Figure 28 – Creepage distance and air clearance – Example 7
Figure 29 – Creepage distance and air clearance – Example 8
Figure 30 – Creepage distance and air clearance – Example 9
Figure 31 – Creepage distance and air clearance – Example 10
Figure 32 – Ratio between hydraulic test pressure and maximum permissible working pressure
Figure 33 – Human body test mass (see 18.104.22.168) Body upper-carriage module
Figure 34 – Spark ignition test apparatus
Figure 35 – Maximum allowable current I as a function of the maximum allowable voltage U ...
Figure 36 – Maximum allowable voltage U as a function of the capacitance C measured in a ...
Figure 37 – Maximum allowable current I as a function of the inductance L measured in an ...
Figure 38 – Baffle
Figure 39 – Area of the bottom of an enclosure as specified in 11.3?b)?1)
Figure A.1 – Identification of me equipment, applied parts and patient connections in an ...
Figure A.2 – Example of the insulation of an f-type applied part with the insulation inco...
Figure A.3 – Identification of me equipment, applied parts and patient connections in a p...
Figure A.4 – Identification of me equipment, applied parts and patient connections in a m...
Figure A.5 – Identification of applied parts and patient connections in an X-ray me system
Figure A.6 – Identification of me equipment, applied parts and patient connections in a t...
Figure A.7 – Identification of me equipment or me system, applied parts and patient conne...
Figure A.8 – Pictorial representation of the relationship of hazard, sequence of events, ...
Figure A.20 – Relationship of the terms used to describe equipment,accessories or equipme...
Figure A.9 – Example of patient environment
Figure A.10 – Floating circuit
Figure A.11 – Interruption of a power-carrying conductor between me?equipment parts in se...
Figure A.12 – Identification of means of patient protection and means of operator protect...
Figure A.13 – Allowable protective earth impedance where the fault current is limited
Figure A.14 – Probability of ventricular fibrillation
Figure A.15 – Example of a measuring circuit for the patient leakage current from apatien...
Figure A.16 – Instability test conditions
Figure A.17 – Example of determining tensile safety factor using Table 21
Figure A.18 – Example of determining design and test loads
Figure A.19 – Example of human body mass distribution
Figure A.22 – Maximum allowable temperature for surfaces and applied partsat higher altit...
Figure A.23 – Example of the needed means of operator protection between the terminals of...
Figure E.1 – Type b applied part
Figure E.2 – Type bf applied part
Figure E.3 – Type cf applied part
Figure E.4 – Patient auxiliary current
Figure E.5 – Loading of the patient connections if specified by the manufacturer
Figure F.1 – Measuring supply circuit with one side of the supply mains at approximately ...
Figure F.2 – Measuring supply circuit with supply mains approximately symmetrical to eart...
Figure F.3 – Measuring supply circuit for polyphase me?equipment specified for connection...
Figure F.4 – Measuring supply circuit for single-phase me?equipment specified for connect...
Figure F.5 – Measuring supply circuit for me?equipment having a separate power supply uni...
Figure G.1– Maximum allowable current IZR as a function of the maximum allowable voltage ...
Figure G.2 – Maximum allowable voltage UZC as a function of the capacitance Cmax measured...
Figure G.3 – Maximum allowable current IZL as a function of the inductance Lmax measured ...
Figure G.4 – Maximum allowable current IZR as a function of the maximum allowable voltage...
Figure G.5 – Maximum allowable voltage UZC as a function of the capacitance Cmax measured...
Figure G.6 – Maximum allowable current IZL as a function of the inductance Lmax measured ...
Figure G.7 – Test apparatus
Figure H.1 – Examples of PEMS/ PESS structures
Figure H.2 – A pems development life-cycle model
Figure H.3 ? Not used
Figure H.4 ? Example of potential parameters required to be specified for an IT-network
Figure I.1 – Example of the construction of a multiple socket-outlet (mso)
Figure I.2 – Examples of application of multiple socket-outlets (mso)
Figure J.1 – Insulation example 1
Figure J.2 – Insulation example 2
Figure J.3 – Insulation example 3
Figure J.4 – Insulation example 4
Figure J.5 – Insulation example 5
Figure J.6 – Insulation example 6
Figure J.7 – Insulation example 7
Figure K.1 – Me?equipment with an enclosure made of insulating material
Figure K.2 – Me?equipment with an f-type applied part
Figure K.3 – Me?equipment with an applied part and a signal input/output part
Figure K.4 – Me?equipment with a patient connection of a type b applied part that is not ...
Figure K.5 – Me?equipment with a patient connection of a type bf applied part that is not...
Table 1 – Units outside the SI units system that may be used on me?equipment
Table 2 – Colours of indicator light
s and their meaningfor me?equipment
Table 3 ? * Allowable values of patient leakage currents and patient auxiliary currents u...
Table 4 ? * Allowable values of patient leakage currents under the special test condition...
Table 5 ? Legends of symbols for Figure 9 to Figure 11, Figure 13 to Figure 20, Figure A....
Table 6 – Test voltages for solid insulation forming a means of protection
Table 7 – Test voltages for means of operator protection
Table 8 – Multiplication factors for air clearancesfor altitudes up to 5?000?m
Table 9 – Material group classification
Table 10 – Mains transient voltage
Table 11 ? Not used
Table 12 – Minimum creepage distances and air clearances providingmeans of patient protec...
Table 13 – Minimum air clearances providing means of operator protection from the mains p...
Table 14 – Additional air clearances for insulation in mains parts with peak working volt...
Table 15 – Minimum air clearances for means of operator protection in secondary circuits
Table 16 ? Minimum Creepage distances providing means of operator protection
Table 17 – Nominal cross-sectional area of conductors of a power supply cord
Table 18 – Testing of cord anchorages
Table 19 – Mechanical hazards covered by this clause
Table 20 ? Acceptable gaps
Table 21 – Determination of tensile safety factor
Table 22 – Allowable maximum temperatures of parts
Table 23 – Allowable maximum temperatures for me?equipment partsthat are likely to be tou...
Table 24 – Allowable maximum temperatures for skin contactwith me?equipment applied parts
Table 25 – Acceptable perforation of the bottom of an enclosure
Table 26 ? * Temperature limits of motor windings
Table 27 – Maximum motor winding steady-state temperature
Table 28 – Mechanical strength test applicability
Table 29 – Drop height
Table 30 – Test torques for rotating controls
Table 31 ? Maximum allowable temperatures of transformer windings under overload and shor...
Table 32 – Test current for transformers
Table A.1 – Values of air clearance and creepage distance derived from Table 7 of IEC?610...
Table A.2 – Creepage distances to avoid failure due to tracking from IEC?60664-1
Table A.3 – Instability test conditions
Table A.4 – Allowable time exposure for level of acceleration
Table A.5 – Guidance on surface temperatures for me?equipment that creates low temperatur...
Table C.1? Marking on the outside of me equipment, me systems or their parts
Table C.2 – Marking on the inside of me?equipment, me?systems or their parts
Table C.3 – Marking of controls and instruments
Table C.4 – Accompanying documents, general
Table C.5 – Accompanying documents, instructions for use
Table D.1 – General symbols
Table D.2 – Safety signs
Table D.3 – General codes
Table G.1 – Gas-tightness of cord inlets
Table H.1 ? Not used
Table I.1 – Some examples of me?systems for illustration
Table L.1– Mandrel diameter
Table L.2 – Oven temperature
Table M.1 – Reduction of the pollution degree of internal environment through the use of ...
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