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AS/NZS 4434.1:1996

AS/NZS 4434.1:1996

Medical electrical equipment - Medical electron accelerators Functional performance characteristics

Standards Australia

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Table of Contents

1 -  AS/NZS 4434.1:1996 MEDICAL ELECTRICAL EQUIPMENT-MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
4 -  PREFACE
 5 -  CONTENTS
 7 -  INTRODUCTION
 7 -  1 Scope and object
7 -  1.1 Scope
 7 -  1.2 Object
 8 -  1.3 Environmental conditions
8 -  1.3.1 General
 8 -  1.3.2 Transport and storage
 8 -  1.3.3 Power supply
 8 -  2 Terminology
8 -  2.1 Definitions
 9 -  2.2 Degree of requirements
 9 -  3 General information to the USER
9 -  3.1 Available NOMINAL ENERGIES and ABSORBED DOSE RATES
 9 -  3.2 Available RADIATION FIELDS
 9 -  3.3 NORMAL TREATMENT DISTANCE
 9 -  3.4 Available FILTERS
 10 -  3.5 Availability
 10 -  3.6 Influencing quantities
 10 -  3.7 Maintenance
 10 -  3.8 Presentation
 10 -  4 Standardized test conditions
10 -  4.1 Angle settings
 10 -  4.2 Properties and positioning of the PHANTOM
 10 -  4.3 Positioning of measuring points
 11 -  4.4 RADIATION DETECTORS
 11 -  4.5 STANDARD MEASUREMENT DEPTHS
11 -  4.5.1 X-RAY BEAMS
 11 -  4.5.2 ELECTRON BEAMS
 11 -  4.6 RADIATION FIELDS
 11 -  4.7 ADJUSTMENTS DURING TEST
 11 -  5 DOSE MONITORING SYSTEM
12 -  5.1 Reproducibility
 13 -  5.2 Proportionality
13 -  5.2.1 Requirement
 13 -  5.2.2 Information to the USER
 13 -  5.2.3 Test
 13 -  5.3 Dependence on angular positions
13 -  5.3.1 Information to the USER
 14 -  5.3.2 Test
 15 -  5.4 Dependence on GANTRY rotation
15 -  5.4.1 Information to the USER
 15 -  5.4.2 Test
 15 -  5.5 Dependence on the shape of the RADIATION FIELD
15 -  5.5.1 Information to the USER
 16 -  5.5.2 Test
 16 -  5.6 Stability of calibration
16 -  5.6.1 Stability after high ABSORBED DOSE delivered
 17 -  5.6.2 Stability throughout the day
 17 -  5.6.3 Stability throughout the week
 18 -  5.7 Stability in MOVING BEAM RADIOTHERAPY
18 -  5.7.1 Information to the USER
 18 -  5.7.2 Test
 19 -  6 Depth ABSORBED DOSE characteristics
19 -  6.1 X-RADIATION
19 -  6.1.1 Depth dose charts
 20 -  6.1.2 SURFACE DOSE
 20 -  6.1.3 Isodose charts
 21 -  6.2 ELECTRON RADIATION
21 -  6.2.1 Depth dose charts
 21 -  6.2.2 Stability of PENETRATIVE QUALITY
 22 -  6.2.3 SURFACE DOSE
 23 -  6.2.4 Isodose charts
 23 -  7 Uniformity of RADIATION FIELDS
23 -  7.1 X-RADIATION
23 -  7.1.1 Flatness of square X-RAY FIELDS
 24 -  7.1.2 Deviation of dose distribution of square X-RAY FIELDS with angular positions
 25 -  7.1.3 Symmetry of square X-RAY FIELDS
 26 -  7.1.4 Maximum ratio of ABSORBED DOSE
 27 -  7.1.5 X-RAY FIELDS with WEDGE FILTER
 28 -  7.2 ELECTRON RADIATION
28 -  7.2.1 Flatness of ELECTRON FIELDS
 29 -  7.2.2 Deviation of dose distribution of ELECTRON FIELDS with angular positions
 29 -  7.2.3 Symmetry of ELECTRON FIELDS
 30 -  7.2.4 Maximum ratio of ABSORBED DOSE
 30 -  7.3 Penumbra of RADIATION FIELDS
30 -  7.3.1 Information to the USER
 30 -  7.3.2 Test
 31 -  8 Indication of RADIATION FIELDS
31 -  8.1 X-RADIATION
31 -  8.1.1 Numerical field-indication
 33 -  8.1.2 LIGHT FIELD-INDICATOR
 34 -  8.1.3 Reproducibility
 34 -  8.2 ELECTRON RADIATION
34 -  8.2.1 Numerical field-indication
 35 -  8.2.2 LIGHT FIELD-INDICATOR
 36 -  8.3 Geometry of the BEAM LIMITING SYSTEM for X-RADIATION
36 -  8.3.1 Information to the USER
 36 -  8.3.2 Test
 36 -  8.4 Illuminance and penumbra of the LIGHT FIELD
36 -  8.4.1 Information to the USER
 37 -  8.4.2 Test
 37 -  9 Indication of the RADIATION BEAM AXIS
37 -  9.1 Indication on entry to the PATIENT
37 -  9.1.1 Information to the USER
 37 -  9.1.2 Test
 39 -  9.2 Indication on exit from the PATIENT
39 -  9.2.1 Information to the USER
 39 -  9.2.2 Test
 39 -  10 ISOCENTRE
39 -  10.1 Displacement of the RADIATION BEAM AXIS from the ISOCENTRE
40 -  10.1.1 Information to the USER
 40 -  10.1.2 Test
 41 -  10.2 Indication of the ISOCENTRE
41 -  10.2.1 Information to the USER
 41 -  10.2.2 Test
 41 -  11 Indication of distance along the RADIATION BEAM AXIS
41 -  11.1 Indicating device
 42 -  11.2 Additional indicating device for equipment with variable distance between RADIATION SOURCE and ISOCENTRE and for...
42 -  11.2.1 Information to the USER
 42 -  11.2.2 Test
 42 -  12 Zero position of rotational scales
43 -  12.1 Information to the USER
 43 -  12.2 Tests
43 -  12.2.1 Rotation of the GANTRY, Axis 1 and pitch of the RADIATION HEAD. Axis 3
 43 -  12.2.2 Roll of the RADIATION HEAD, Axis 2 (Figures 1, 2 and 3)
 43 -  12.2.3 Rotation of the BEAM LIMITING SYSTEM, Axis 4 (Figures 1, 2 and 3)
 43 -  12.2.4 ISOCENTRIC rotation of the table, Axis 5 (Figure 1), and rotation of the table top, Axis 6 (Figure 1)
 44 -  12.2.5 Pitch and roll of the table, Axes 7 and 8 (Figure 1)
 44 -  13 Congruence of opposed RADIATION FIELDS
44 -  13.1 Information to the USER
 44 -  13.2 Test
 44 -  14 Movements of the PATIENT table
44 -  14.1 Vertical movement of the table
44 -  14.1.1 Information to the USER
 45 -  14.1.2 Test
 46 -  14.2 ISOCENTRIC rotation of the table
46 -  14.2.1 Information to the USER
 46 -  14.2.2 Test
 46 -  14.3 Parallelism of table rotational axes
46 -  14.3.1 Information to the USER
 46 -  14.3.2 Test
 47 -  14.4 Rigidity of the table
47 -  14.4.1 Longitudinal rigidity of the table
 47 -  14.4.2 Lateral rigidity of the table
 58 -  APPENDIX A - TERMINOLOGY
58 -  A1. Index of terms
 59 -  A2. Definitions
 64 -  APPENDIX B - FORMAT FOR PRESENTATION OF FUNCTIONAL PERFORMANCES VALUES

Abstract

Specifies test procedures for the determination and disclosure of functional performance characteristics for electron accelerators to enable intending purchasers to compare performance of different models. It is identical with and has been reproduced from IEC 976:1989.

Scope

This standard applies to MEDICAL ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice.
This standard applies to ELECTRON ACCELERATORS which deliver a RADIATION BEAM
of either X-RADIATION OR ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV
to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s-1and 1 Gy s-1at 1 m from
the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the RADIATION SOURCE.
The present standard describes a set of measurements requiring two to three months' work to complete. It specifies test procedures to be performed by the manufacturer at the design and construction stage of a MEDICAL ELECTRON ACCELERATOR but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC Publication 977, however, does suggest that many of the test procedures are appropriate for acceptance tests.
The measurement conditions described in the present standard differ from those currently in use. This applies particularly to the PHANTOM position for measurements and the measurement of distances from the ISOCENTRE. These new conditions should be substituted for and not be added to present methods.

General Product Information

Document Type Standard
Status Current
Publisher Standards Australia
ProductNote Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Committee HE-003
Supersedes
  • DR 96123

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