04/30106146 DC : DRAFT MARCH 2004

FOREWORD
INTRODUCTION
1. Scope, object and related standards
    1.1 Scope
    1.2 Object
    1.3 Particular standards
    1.4 Collateral 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 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
    4.6 ME EQUIPMENT or ME SYSTEMS parts that contact the PATIENT
    4.7 NORMAL CONDITION and 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
    6.1 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
7, ME EQUIPMENT identification, marking and documents
    7.1 General
    7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
    7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
    7.4 Marking of controls and instruments
    7.5 Safety signs
    7.6 Symbols
    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
    8.8 Insulation
    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 HAZARDS associated with moving parts
    9.3 HAZARD associated with surfaces, corners and edges
    9.4 Instability HAZARDS
    9.5 Expelled parts HAZARD
    9.6 Noise, vibration and acoustic energy (including
         infra- and ultrasound)
    9.7 Pressure vessels and parts subject to pneumatic
         and hydraulic pressure
    9.8 HAZARDS associated with support systems
10. Protection against unwanted and excessive radiation HAZARDS
    10.1 X-Radiation
    10.2 Alpha, beta, gamma, neutron radiation and other
         particle radiation
    10.3 Microwave radiation
    10.4 Lasers and laser light emitting diodes
    10.5 Other visual 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,
         cleaning, disinfection, sterilization and
         compatibility with substances used with the ME
         EQUIPMENT
    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
    12.3 Alarm systems
    12.4 Protection against hazardous output
13. Hazardous situations and fault conditions
    13.1 Specific hazardous situations
    13.2 SINGLE FAULT CONDITIONS
14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    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 Connection of PEMS by NETWORK/DATA COUPLING to
          other equipment
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 accordance
          with 8.5
16. ME SYSTEMS
    16.1 General requirements for the ME SYSTEMS
    16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
    16.3 Power supply
    16.4 ENCLOSURES
    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
ANNEXES
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 SYSTEMS
Annex D (Informative) Symbols on marking
Annex E (Informative) Examples of the connection of the measuring
        device (MD) for measurement of the PATIENT LEAKAGE CURRENT
        and PATIENT AUXILIARY CURRENT
Annex F (Informative) Suitable measuring supply circuits
Annex G (Normative) Protection against HAZARDS of ignition of
        flammable anaesthetic mixtures
Annex H (Informative) PEMS structures, 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
Bibliography
Index of defined terms
Index of abbreviations and acronyms
Editing notes for the second CDV

BS EN 60601-1.