IEC 60601-2-15:1988

Contents
Foreword
Preface
Section One - General
Clause
1. Scope and object
    1.1 Scope
    1.2 Object
    1.3 Particular standards
    1.4 Environmental conditions
2. Terminology and definitions
    2.12 Miscellaneous
3. General requirements
    3.101 Conventional meanings of electrical quantities
    3.102 Radiation quantities
4. General requirements for tests
    4.1 Type and routine tests
    4.10 Moisture pre-conditioning treatment
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
    6.7 Indicator lights and push buttons
    6.8 Accompanying Documents
7. Power input
Section Two - Safety Requirements
8. Basic safety categories
9. Removable protective means
10. Special environmental conditions
11. Special measures with respect to safety
12. Single fault condition
Section Three - Protection Against Electric Shock Hazards
13. General
14. Requirements related to classification
15. Limitation of voltage and/or current
16. Enclosures and Protective Covers
17. Insulation and Protective Impedances
18. Earthing and potential equalization
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 Four - Protection Against Mechanical Hazards
21. Mechanical strength
22. Moving parts
23. Surfaces, corners and edges
24. Stability and transportability
25. Expelled parts
26. Vibration and noise
27. Pneumatic and hydraulic power
28. Suspended masses
Section Five - Protection Against Hazards from Unwanted
or Excessive Radiation
29. X-radiation
    29.1 X-Radiation generated by diagnostic Capacitor
         Discharge X-Ray Generators
30. Alpha, beta, gamma, neutron radiation and other
    particle radiation
31. Microwave radiation
32. Light radiation (including visual radiation and lasers)
33. Infra-red radiation
34. Ultra-violet radiation
35. Acoustical energy (including ultrasonics)
36. Electromagnetic compatibility
Section Six - Protection Against Hazards of Explosions
in Medically Used Rooms
37. General
38. Classification, marking and Accompanying Documents of
    Anaesthetic-Proof Equipment
39. Common requirements for "AP" and "APG" equipment
40. Requirements and tests for Anaesthetic-Proof Equipment,
    equipment parts or components (AP)
41. Requirements and tests for Anaesthetic-Proof Category
    G Equipment, equipment parts or components
Section Seven - Protection Against Excessive Temperatures,
Fire and Other Hazards, such as Human Errors
42. Excessive temperatures
    42.1 Addition
    42.5 Guards
43. Fire prevention
44. Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization and disinfection
45. Pressure vessels and parts subject to pressure
46. Human errors
47. Electrostatic charges
48. Materials in Applied Parts in contact with the body of
    the Patient
49. Interruption of the power supply
Section Eight - Accuracy of Operating Data and Protection
Against Incorrect Output
50. Accuracy of operating data
    50.1 Indication of electric and radiation output
    50.101 through 50.103 - Requirements on Operational
           Data
    50.101 Reproducibility of radiation output
    50.102 Agreement between indicated and measured values
           of Loading Factors
    50.103 Correction for fluctuations of Mains Voltage
    50.104 Test conditions
    50.105 General
    50.106 Methods of measuring Loading Factors
    50.107 Conditions for measuring Air Kerma
    50.108 and 50.109 - Preselected Loading Factors for
           Tests
    50.108 Combination of Loading Factors for the
           determination of Coefficient of Variation
    50.109 Combination of Loading Factors for the
           determination of Per Cent Average Error
51. Protection against incorrect output
Section Nine - Fault Conditions Causing Overheating and/or
Mechanical Damage; Environmental Tests
52. Fault conditions causing overheating and/or mechanical
    damage
53. Environmental tests
Section Ten - Constructional Requirements
54. General
55. Enclosures and covers
56. Components and general assembly
    56.8 Indicators
    56.11 Switches
57. Mains Parts, components and layout
    57.1 Separation from the Supply Mains
    59.9 Mains supply transformers and Medical Isolating
         Transformers
    57.10 Creepage Distances and Air Clearances
58. Protective Earth Terminals
59. Construction and layout
    59.4 Oil containers
Figure 101 - Total Filtration for the measurement of Air
Kerma
Table 101 - Permissible Per Cent Average Error of Loading
Factors
Appendix AA - Terminology
         AA1 - Alphabetical Index of French terms
         AA2 - Alphabetical Index of English terms

Establishes requirements applying to capacitor discharge X-ray generators for medical radiology in which electrical energy for loading of the X-ray tube is primarily stored at and switched in the high-voltage circuit. Its object is to ensure safety and tospecify methods for demonstrating compliance with the safety requirements.