00/565497 DC : DRAFT DEC 2000

Foreword
Introduction
SECTION ONE - GENERAL
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for tests
6 Classification
7 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC HAZARDS
8 Fundamental rule of protection against
  electric shock
9 Requirements related to power sources
10 Classification of APPLIED PARTS
11 Limitation of voltage, current or energy
12 Separation
13 Protective earthing, functional earthing and
   potential equalization
14 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
15 Insulation
16 CREEPAGE DISTANCES and AIR CLEARANCES
17 Components and wiring
18 MAINS PARTS, components and layout
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
19 MECHANICAL HAZARDS
20 Moving parts
21 Surfaces, corners and edges
22 Stability in NORMAL USE
23 Expelled parts
24 Noise and vibration
25 Pressure vessels and parts subject to pneumatic
   and hydraulic PRESSURE
26 Support systems
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
27 General
28 Unintended X-Radiation
29 Alpha, beta, gamma, neutron radiation and other
   particle radiation
30 Microwave radiation
31 Optical radiation
32 Infra-red radiation
33 Ultraviolet radiation
34 Unintended acoustic pressure (including ultrasonics)
SECTION SIX - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER HAZARDS
35 Excessive temperatures
36 Fire prevention
37 Overflow, spillage, leakage, ingress of liquids, cleaning,
   disinfection, sterilization and compatibility with substances
   used with the MEDICAL ELECTRICAL EQUIPMENT
38 Biocompatibility
39 Interruption of the power supply/SUPPLY MAINS
SECTION SEVEN - ACCURACY OF OPERATING DATA, PROTECTION
AGAINST HAZARDOUS OUTPUT AND ESSENTIAL PERFORMANCE
40 ESSENTIAL PERFORMANCE
41 Use error
42 Alarm systems
43 Accuracy of controls and instruments
44 Protection against hazardous output
SECTION EIGHT - ABNORMAL OPERATION AND FAULT CONDITIONS
45 Abnormal operation and fault conditions
SECTION NINE - PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
46 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
47 General
48 Mechanical strength
49 Components and general assembly
50 MAINS SUPPLY TRANSFORMERS and transformers providing
   separation in accordance with Clause 12
51 Construction and layout
SECTION ELEVEN - REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
52 Introduction
53 General requirements for the MEDICAL ELECTRICAL SYSTEM
54 ACCOMPANYING DOCUMENTS of a MEDICAL ELECTRICAL SYSTEM
55 Power supply
56 Enclosures
57 Electrical separation
LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
59 Protective means for moving parts
60 Interruption of the power supply
61 MEDICAL ELECTRICAL SYSTEM connecting and wiring
SECTION TWELVE - ELECTROMAGNETIC COMPATIBILITY
62 General requirements for electromagnetic compatibility
   of MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL
   SYSTEMS
63 Electromagnetic emissions
64 Electromagnetic immunity
SECTION THIRTEEN - REQUIREMENTS FOR ENVIRONMENTAL PROTECTION
65 Introduction
66 Design and useful life
67 Disassembly, REUSE, RECYCLING and disposal
TABLES
Table 1 Specified atmospheric conditions
Table 2 Safety warning signs and caution symbols
Table 3 Colours of indicator lights and their meaning for
        MEDICAL ELECTRICAL EQUIPMENT
Table 4 Allowable values of PATIENT LEAKAGE CURRENTS and
        PATIENT AUXILIARY CURRENTS, in microamperes
Table 5 Test voltages for testing MEANS OF PROTECTION
Table 6 Test voltages
Table 7 CREEPAGE DISTANCES and AIR CLEARANCES in millimetres
        between parts of opposite polarity of MAINS PART
Table 8 CREEPAGE DISTANCES and AIR CLEARANCES in millimetres
        providing MEANS OF PATIENT PROTECTION
Table 9 Minimum AIR CLEARANCES in millimetres providing
        MEANS OF USER PROTECTION
Table 10 Minimum CREEPAGE DISTANCES in millimetres
         providing MEANS OF USER PROTECTION
Table 11 NOMINAL cross-sectional area of conductors of
         POWER SUPPLY CORDS
Table 12 Testing of cord anchorages
Table 13 MECHANICAL HAZARDS covered by this section
Table 14 Minimum gaps in millimetres
Table 15 Determination of SAFETY FACTOR
Table 16 Allowable maximum temperatures of parts
Table 17 Allowable maximum temperatures for MEDICAL
         ELECTRICAL EQUIPMENT parts that are likely to
         be touched
Table 18 Temperature limits of motor windings, in
         degree C
Table 19 Maximum motor winding steady-state temperature
         degree C
Table 20 Mechanical strength test matrix
Table 21 Drop height
Table 22 Test torques for rotating controls
Table 23 Maximum allowable temperatures at 25 degree C
         ambient temperature of transformer windings
         under overload and short-circuit conditions
Table 24 Test current for transformers
Table C1 General symbols and codes
Table F1 Gas-tightness of cord inlets
Table G1 Marking on the outside of MEDICAL ELECTRICAL
         EQUIPMENT or MEDICAL ELECTRICAL EQUIPMENT
         parts
Table G2 Marking on the inside of MEDICAL ELECTRICAL
         EQUIPMENT or MEDICAL ELECTRICAL EQUIPMENT
         parts
Table G3 Marking of controls and instruments
Table G4 ACCOMPANYING DOCUMENTS, Instruction for use
Table G5 ACCOMPANYING DOCUMENTS, Technical description
Table G6 ACCOMPANYING DOCUMENTS, General
Table H1 Suggested correlation of the documentation
         requirement to the DEVELOPMENT LIFE-CYCLE
         phases
Table J1 Some examples of MEDICAL ELECTRICAL SYSTEMS
         for illustration
Table K1 Instructions for an easy-to-dismantle
         construction
FIGURES
Figure 1 - Detachable mains connection
Figure 2 - Example of the defined terminals and conductors
Figure 3 - Example of a CLASS I EQUIPMENT
Figure 4 - Example of a metal-enclosed CLASS II 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
           CONNECTIONS for DEFIBRILLATION-PROOF APPLIED PARTS
Figure 10 - Application of test voltage to individual PATIENT
            CONNECTIONS for DEFIBRILLATION-PROOF APPLIED PARTS
Figure 11 - Example of a measuring device and its frequency
            characteristics
Figure 12 - Measuring circuit for the EARTH LEAKAGE CURRENT of
            CLASS I EQUIPMENT, with or without APPLIED PART
Figure 13 - Measuring circuit for the TOUCH/CHASSIS LEAKAGE
            CURRENT
Figure 14 - Measuring circuit for the PATIENT LEAKAGE CURRENT
            from the APPLIED PART to earth
Figure 15 - Measuring circuit for the PATIENT LEAKAGE CURRENT
            via and F-TYPE APPLIED PART to earth caused by an
            external voltage on the APPLIED PART
Figure 16 - Measuring circuit for the PATIENT LEAKAGE CURRENT
            from APPLIED PART to earth caused by an external
            voltage on a SIGNAL INPUT/OUTPUT PART
Figure 17 - Measuring circuit for the PATIENT AUXILIARY CURRENT
Figure 18 - Example of a circuit for dielectric strength test
            at operating temperature for heating elements
Figure 19 - Ball-pressure test apparatus
Figure 20 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 1
Figure 21 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 2
Figure 22 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 3
Figure 23 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 4
Figure 24 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 5
Figure 25 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 6
Figure 26 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 7
Figure 27 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 8
Figure 28 - CREEPAGE DISTANCE and AIR CLEARANCE - Example 9
Figure 29 - Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM
            PERMISSIBLE WORKING PRESSURE
Figure 30 - Human body mass distribution
Figure 31 - Human body test mass
Figure 32 - Spark ignition test apparatus
Figure 33 - Maximum allowable current I as a function of the
            maximum allowable voltage U measured in a
            purely resistive circuit in an OXYGEN RICH
            ENVIRONMENT
Figure 34 - Maximum allowable voltage U as a function of the
            capacitance C measured in a capacitive circuit
            used in an OXYGEN RICH ENVIRONMENT
Figure 35 - Maximum allowable current I as a function if the
            inductance L measured in an inductive circuit
            in an OXYGEN RICH ENVIRONMENT
Figure 36 - Shape of control knobs
Figure A1 - Floating circuit
Figure A2 - PATIENT ENVIRONMENT
Figure A3 - Interruption of a power-carrying conductor between
            MEDICAL ELECTRICAL EQUIPMENT parts in separate
            ENCLOSURES
Figure A4 - Allowable protective earth impedance where the fault
            current is limited
Figure A5 - Probability of ventricular fibrillation
Figure A6 - Example of determining SAFETY FACTOR using Table 15
Figure A7 - Example of determining of design and test loads
Figure A8 - Schematic representation of the Input-output-relation
            of a system
Figure D1 - TYPE B APPLIED PART
Figure D2 - TYPE BF APPLIED PART
Figure D3 - TYPE CF APPLIED PART
Figure D4 - PATIENT AUXILIARY CURRENT
Figure E1 - Measuring supply circuit with one side of the SUPPLY
            MAINS at approximately earth potential
Figure E2 - Measuring supply circuit with SUPPLY MAINS
            approximately symmetrical to earth potential
Figure E3 - Measuring supply circuit for polyphase MEDICAL
            ELECTRICAL EQUIPMENT specified for connection
            to a polyphase SUPPLY MAINS
Figure E4 - Measuring supply circuit for single-phase MEDICAL
            ELECTRICAL EQUIPMENT specified for connection
            to a polyphase SUPPLY MAINS
Figure E5 - Measuring supply circuit for MEDICAL ELECTRICAL
            EQUIPMENT intended to receive its power from
            another equipment in a MEDICAL ELECTRICAL SYSTEM
Figure F1 - Maximum allowable current I[ZR] as a function
            of the maximum allowable voltage U[ZR] measured
            in a purely resistive circuit with the most
            flammable mixture of ether vapour with air
Figure F2 - Maximum allowable voltage U[ZC] as a function
            of the capacitance C[max] measured in a
            capacitive circuit with the most flammable
            mixture of ether vapour with air
Figure F3 - Maximum allowable current I[ZL] as a function
            of the inductance L[max] measured in an
            inductive circuit with the most flammable
            mixture of ether vapour with air
Figure F4 - Maximum allowable current I[ZR] as a function
            of the maximum allowable voltage U[ZR]
            measured in a purely resistive circuit with
            the most flammable mixture of ether vapour
            with oxygen
Figure F5 - Maximum allowable voltage U[ZC] as a function
            of the capacitance C[max] measured in a
            capacitive circuit with the most flammable
            mixture of ether vapour with oxygen
Figure F6 - Maximum allowable current I[ZL] as a function
            of the inductance L[max] measured in an
            inductive circuit with the most flammable
            mixture of ether vapour with oxygen
Figure F7 - Test apparatus
Figure H1 - Examples of PEMS/PESS structures
Figure H2 - A DEVELOPMENT LIFE-CYCLE model for PEMS
Figure H3 - Content of RISK MANAGEMENT FILE and
            risk management report
ANNEXES
Annex A (Informative) General guidance and rationale
Annex B (Informative) Sequence of testing
Annex C (Informative) Symbol on marking
Annex D (Informative) Examples of the connection of the
         APPLIED PART for measurement of the PATIENT
         LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex E (Informative) Suitable measuring supply circuits
Annex F (Informative) Protection against hazards of ignition
         of flammable anaesthetic mixtures
Annex G (Informative) Guide to the marking and labelling
         requirements for MEDICAL ELECTRICAL EQUIPMENT and
         MEDICAL ELECTRICAL SYSTEMS
Annex H (Informative) PEMS structure, DEVELOPMENT LIFE-CYCLE
         and documentation
Annex J (Informative) MEDICAL ELECTRICAL SYSTEMS aspects
Annex K (Informative) Instructions for an easy-to-dismantle
         construction
Annex L (Informative) Requirements tracking matrix
Bibliography
Index of defined terms
Index of abbreviations and acronyms
Editing notes on the second committee draft