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