EN 60601-2-7:1998

SECTION 1: GENERAL
1 Scope and object
    1.1 Scope
    1.2 Object
    1.3 Particular Standards
2 Terminology and definitions
    2.101 Qualifying conditions for defined terms
3 General requirements
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of equipment or equipment
          parts
    6.7 Indicator lights and push-buttons
    6.8 Accompanying documents
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
19 Continuous leakage currents and patient auxiliary
    currents
    19.3 Allowable values
20 Dielectric strength
    20.3 Values of test voltages
    20.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
29 X-radiation
    29.1 X-Radiation generated by diagnostic X-ray
          generators containing high-voltage generators
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
42 Excessive temperatures
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
50 Accuracy of operating data
    50.1 General
          50.101 Indication of electric and radiation output
          50.102 Reproducibility, linearity and constancy
          50.103 Accuracy of loading factors
          50.104 Test conditions
          50.105 Conditions for measuring air kerma
51 Protection against hazardous output
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
    56.7 Batteries
57 Mains parts, components and layout
    57.10 Creepage distances and air clearances
Tables
101 Reference values for the apparent resistance of supply
     mains
102 Duration of dielectric strength test
103 Loadings for testing automatic exposure controls
104 Attenuation for the measurement of air kerma
105 Tests for verifying reproducibility and linearity
CC.1 Recommended loading factors for the testing of accuracy
CC.2 Test settings for measurement of air kerma
Figures
101 Recommended arrangement for measuring air kerma
102 Recommended arrangement for film density testing
     automatic control systems provided with a transmission
     chamber
Annexes
AA Terminology - Index of defined terms
BB Values of the series R'10 and R'20, ISO 497
CC Choosing loading factors for tests

Applies to high-voltage generators of medical diagnostic X-ray generators and to their subassemblies including the following : - high-voltage generators that are integrated with an X-ray tube assembly; - high-voltage generators of radiotherapy treatment simulators. The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.