UL 60601-1
Medical Electrical Equipment, Part 1: General Requirements for Safety

DETAILS
Edition Number:1SCC Approved:--
Edition Date:2003-04-25DOD Approved: --
Price Code:HANSI Approved: --
Type:uliec

  • SCOPE

    1 *Scope and object

    1

    1.1 Scope

    This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).

    Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.

    SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.

    Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.

    1.1DV Replacement of the third paragraph of 1.1 with the following:

    SAFETY HAZARDS resulting from intended physiological function of EQUIPMENT covered by this Standard are not considered. These requirements do not contemplate the investigation of protection against ionizing radiation or radioactive isotopes. Such EQUIPMENT is subject to Federal radiation Standards ( 21CFR Part 1020) promulgated under the Radiation Control for Health and Safety Act of 1968.

    1.2 Object

    The object of this Standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards.

    1.3 *Particular Standards

    A Particular Standard takes priority over this General Standard.

    1.4 Environmental conditions

    See Section Two.

    1.5 Collateral Standards

    In the IEC 601 series, Collateral Standards specify general requirements for safety applicable to:

    – a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);

    – a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (e.g. electromagnetic compatibility).

    If a Collateral Standard applies to a Particular Standard, then the Particular Standard takes priority over the Collateral Standard.

  • TABLE OF CONTENTS
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    • Cover
    • Transmittal
    • Table of Contents
    • UL Introduction
    • UL Preface
    • UL Foreword
    • Deviations
    • IEC Foreword
    • IEC Preface
    • IEC Introduction
      • MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for safety
        • SECTION ONE – GENERAL
          • 1 *Scope and object
            • 1.1 Scope
            • 1.2 Object
            • 1.3 *Particular Standards
            • 1.4 Environmental conditions
            • 1.5 Collateral Standards
          • 2 Terminology and definitions
            • 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
            • 2.2 EQUIPMENT types (classification)
            • 2.3 Insulation
            • 2.4 Voltages
            • 2.5 Currents
            • 2.6 Earth terminals and conductors
            • 2.7 Electrical connection (devices)
            • 2.8 Transformers
            • 2.9 Controls and limiting devices
            • 2.10 Operation of EQUIPMENT
            • 2.11 Mechanical safety
            • 2.12 Miscellaneous
          • 3 General requirements
            • 3.10DV.1 Components
            • 3.10DV.2 Primary circuit components
          • 4 *General requirements for tests
            • 4.1 *Tests
            • 4.2 Repetition of tests
            • 4.3 *Number of samples
            • 4.4 Components
            • 4.5 Ambient temperature, humidity, atmospheric PRESSURE
            • 4.6 Other conditions
            • 4.7 Supply and test voltages, type of current, nature of supply, frequency
            • 4.8 *Preconditioning
            • 4.9 Repairs and modifications
            • 4.10 *Humidity preconditioning treatment
            • 4.11 Sequence
          • 5 *Classification
          • 6 Identification, marking and documents
            • 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
            • 6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts
            • 6.3 Marking of controls and instruments
            • 6.4 *Symbols
            • 6.5 Colours of the insulation of conductors
            • 6.6 Identification of medical gas cylinders and connections
            • 6.7 *Indicator lights and push-buttons
            • 6.8 ACCOMPANYING DOCUMENTS
          • 7 Power input
        • SECTION TWO – ENVIRONMENTAL CONDITIONS
          • 8 *Basic safety categories
          • 9 Removable protective means
          • 10 Environmental conditions
            • 10.1 Transport and storage
            • 10.2 Operation
          • 11 Not used.
          • 12 Not used.
        • SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
          • 13 General
          • 14 Requirements related to classification
            • 14.1 CLASS I EQUIPMENT
            • 14.2 CLASS II EQUIPMENT
            • 14.4 CLASS I and CLASS II EQUIPMENT
            • 14.5 INTERNALLY POWERED EQUIPMENT
            • 14.6 *TYPES B, BF and CF APPLIED PARTS
          • 15 Limitation of voltage and/or energy
          • 16 *ENCLOSURES and PROTECTIVE COVERS
          • 17 *Separation
          • 18 Protective earthing, functional earthing and potential equalization
          • 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
            • 19.1 General requirements
            • 19.2 SINGLE FAULT CONDITIONS
            • 19.3 *Allowable values
            • 19.4 Tests
          • 20 Dielectric strength
            • 20.1 General requirements for all types of EQUIPMENT
            • 20.2 Requirements for EQUIPMENT with an APPLIED PART
            • 20.3 *Values of test voltages
            • 20.4 Tests
        • SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
          • 21 Mechanical strength
          • 22 *Moving parts
          • 23 Surfaces, corners and edges
          • 24 Stability in NORMAL USE
          • 25 Expelled parts
          • 26 *Vibration and noise
          • 27 Pneumatic and hydraulic power
          • 28 Suspended masses
            • 28.1 General
            • 28.3 Suspension system with SAFETY DEVICES
            • 28.4 Suspension systems of metal without SAFETY DEVICES
            • 28.5 *Dynamic loads
        • SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
          • 29 X-Radiation
          • 30 Alpha, beta, gamma, neutron radiation and other particle radiation
          • 31 Microwave radiation
          • 32 Light radiation (including lasers)
          • 33 Infra-red radiation
          • 34 Ultraviolet radiation
          • 35 Acoustical energy (including ultra-sonics)
          • 36 *Electromagnetic compatibility
        • SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
          • 37 Locations and basic requirements
          • 38 Marking, ACCOMPANYING DOCUMENTS
          • 39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT
            • 39.1 Electrical connections
            • 39.2 Construction details
            • 39.3 Prevention of electrostatic charges
            • 39.4 Corona
          • 40 Requirements and tests for CATEGORY AP EQUIPMENT, parts and components thereof
            • 40.1 General
            • 40.2 Temperature limits
            • 40.3 *Low-energy circuits
            • 40.4 *External ventilation with internal overpressure
            • 40.5 Enclosures with restricted breathing
          • 41 Requirements and tests for CATEGORY APG EQUIPMENT, parts and components thereof
            • 41.1 General
            • 41.2 *Power supply
            • 41.3 *Temperatures and low-energy circuits
            • 41.4 Heating elements
            • 41.5 Humidifiers
        • SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
          • 42 Excessive temperatures
            • 42.5 Guards
          • 43 Fire prevention
            • 43.1 Strength and rigidity
            • 43.2 *Oxygen enriched atmospheres
            • 43.2DV.9 Installation related items
          • 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
            • 44.1 General
            • 44.2 Overflow
            • 44.3 Spillage
            • 44.4 *Leakage
            • 44.5 Humidity
            • 44.6 Ingress of liquids
            • 44.7 Cleaning, sterilization and disinfection
            • 44.8 *Compatibility with substances used with the EQUIPMENT
          • 45 *PRESSURE vessels and parts subject to PRESSURE
          • 46 *Human errors
          • 47 Electrostatic charges
          • 48 Biocompatibility
          • 49 *Interruption of the power supply
        • SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
          • 50 Accuracy of operating data
            • 50.1 Marking of controls and instruments
            • 50.2 Accuracy of controls and instruments
          • 51 Protection against hazardous output
            • 51.1 *Intentional exceeding of safety limits
            • 51.2 *Indication of parameters relevant to safety
            • 51.3 Reliability of components
            • 51.4 Accidental selection of excessive output values
            • 51.5 *Incorrect output
        • SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
          • 52 Abnormal operation and fault conditions
            • 52.5.1 Overloading of mains supply transformers in EQUIPMENT
            • 52.5.2 Failure of THERMOSTATS
            • 52.5.3 Short-circuiting of either constituent part of a DOUBLE INSULATION
            • 52.5.4 Interruption of the PROTECTIVE EARTH CONDUCTOR
            • 52.5.5 Impairment of cooling
            • 52.5.6 Locking of moving parts
            • 52.5.7 *Interruption and short-circuiting of motor capacitors
            • 52.5.8 *Additional tests for motor operated EQUIPMENT
            • 52.5.9 Failure of components
            • 52.5.10 Overload
          • 53 ENVIRONMENTAL TESTS
        • SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
          • 54 *General
            • 54.1 *Arrangements of functions
            • 54.2 *Serviceability
            • 54.3 *Inadvertent changing of settings
          • 55 ENCLOSURES and covers
            • 55DV.3 Flame Spread
            • 55DV.4 Flammability, Mechanical Abuse and Mold Stress Relief
            • 55.1 *Materials
            • 55.2 *Mechanical strength
            • 55.3 ACCESS COVERS
            • 55.4 Grips and other handling devices
          • 56 Components and general assembly
            • 56.1 General
            • 56.2 Screws and nuts
            • 56.3 Connections – General
            • 56.4 *Connections of capacitors
            • 56.5 Protective devices
            • 56.6 Temperature and overload control devices
            • 56.7 Batteries
            • 56.8 Indicators
            • 56.9 Pre-set controls
            • 56.10 Actuating parts of controls
            • 56.11 Cord-connected hand-held and foot-operated control devices
          • 57 MAINS PARTS, components and layout
            • 57DV.1 General
            • 57.1 Isolation from the SUPPLY MAINS
            • 57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
            • 57.3 POWER SUPPLY CORDS
            • 57.4 Connection of POWER SUPPLY CORDS
            • 57.5 MAINS TERMINAL DEVICES and wiring of MAINS PART
            • 57.6 Mains fuses and OVER-CURRENT RELEASES
            • 57.7 *Location of interference suppressors in the MAINS PART
            • 57.8 Wiring of the MAINS PART
            • 57.9 *Mains supply transformers
            • 57.10 *CREEPAGE DISTANCES and AIR CLEARANCES
          • 58 Protective earthing – Terminals and connections
            • 58.9 Protective earth connection
          • 59 Construction and layout
            • 59.1 Internal wiring
            • 59.2 Insulation
            • 59.3 Excessive current and voltage protection
            • 59.4 Oil containers
            • 60DV.1 Separate power units
    • APPENDIX A GENERAL GUIDANCE AND RATIONALE
    • APPENDIX B TESTING DURING MANUFACTURE AND/OR INSTALLATION
    • APPENDIX C SEQUENCE OF TESTING
    • APPENDIX D SYMBOLS ON MARKING(See Clause )
    • APPENDIX E SURVEY OF INSULATION PATHS AND TEST CIRCUITS(See Clause )
    • APPENDIX F TEST APPARATUS FOR FLAMMABLE MIXTURES(See Appendix , Sub-clause )
    • APPENDIX G IMPACT-TEST APPARATUS
    • APPENDIX H SCREWED TERMINAL CONNECTIONS
    • APPENDIX J MAINS SUPPLY TRANSFORMERS
    • APPENDIX K
    • APPENDIX L REFERENCES – PUBLICATIONS MENTIONED IN THIS STANDARD
    • Annex DVA(informative) Standards for Components
    • Annex DVB(informative) Manufacturing and Production Tests
    • Annex DVC(informative) Rationale for national differences
    • INDEX OF DEFINED TERMS