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IEC 60580 : 2.0

IEC 60580 : 2.0

MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS

International Electrotechnical Committee

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Table of Contents

Foreword<br>Introduction<br>1. Scope and object<br>2. Normative references<br>3. Terminology and definitions<br>4. General requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;4.1 Performance requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and DOSE AREA PRODUCT RATE<br>&nbsp;&nbsp;&nbsp;&nbsp;4.3 Plane of measurement<br>&nbsp;&nbsp;&nbsp;&nbsp;4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS<br>&nbsp;&nbsp;&nbsp;&nbsp;4.5 General test conditions<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5.1 STANDARD TEST CONDITIONS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5.2 Test of components<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5.3 STABILIZATION TIME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5.4 Adjustments during test<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5.5 Uniformity of radiation field<br>&nbsp;&nbsp;&nbsp;&nbsp;4.6 Statistical fluctuations<br>&nbsp;&nbsp;&nbsp;&nbsp;4.7 Uncertainty of measurement <br>&nbsp;&nbsp;&nbsp;&nbsp;4.8 Constructional requirements as related to performance<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8.1 Display<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8.2 Indication of polarizing voltage failure<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8.3 Over-ranging<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8.4 Indication of reset or other inactive condition<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8.5 IONIZATION CHAMBER<br>&nbsp;&nbsp;&nbsp;&nbsp;4.9 STABILITY CHECK DEVICE<br>&nbsp;&nbsp;&nbsp;&nbsp;4.10 Adjustment<br>&nbsp;&nbsp;&nbsp;&nbsp;4.11 Electrical safety<br>5. Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST<br>&nbsp;&nbsp;&nbsp;&nbsp;CONDITIONS<br>&nbsp;&nbsp;&nbsp;&nbsp;5.1 RELATIVE INTRINSIC ERROR<br>&nbsp;&nbsp;&nbsp;&nbsp;5.2 Warning function<br>&nbsp;&nbsp;&nbsp;&nbsp;5.3 Repeatability<br>&nbsp;&nbsp;&nbsp;&nbsp;5.4 RESOLUTION of reading<br>&nbsp;&nbsp;&nbsp;&nbsp;5.5 STABILIZATION TIME<br>&nbsp;&nbsp;&nbsp;&nbsp;5.6 Reset on DOSE AREA PRODUCT ranges<br>&nbsp;&nbsp;&nbsp;&nbsp;5.7 Drift of INDICATED VALUES<br>&nbsp;&nbsp;&nbsp;&nbsp;5.8 Long term stability<br>&nbsp;&nbsp;&nbsp;&nbsp;5.9 RESPONSE TIME<br>&nbsp;&nbsp;&nbsp;&nbsp;5.10 Spatial uniformity of RESPONSE<br>6. LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES<br>&nbsp;&nbsp;&nbsp;&nbsp;6.1 Energy dependence of RESPONSE<br>&nbsp;&nbsp;&nbsp;&nbsp;6.2 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;measurements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.1 MEASURING ASSEMBLY<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.2 IONIZATION CHAMBER - Recombination losses<br>&nbsp;&nbsp;&nbsp;&nbsp;6.3 IRRADIATION TIME<br>&nbsp;&nbsp;&nbsp;&nbsp;6.4 Field size<br>&nbsp;&nbsp;&nbsp;&nbsp;6.5 Operating voltage<br>&nbsp;&nbsp;&nbsp;&nbsp;6.6 Air pressure<br>&nbsp;&nbsp;&nbsp;&nbsp;6.7 Temperature and humidity<br>&nbsp;&nbsp;&nbsp;&nbsp;6.8 Air density fluctuation in the IONIZATION CHAMBER<br>&nbsp;&nbsp;&nbsp;&nbsp;6.9 Electromagnetic compatibility<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.1 General<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.2 Electrostatic discharge<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.3 Radiated electromagnetic fields<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.4 Conducted disturbances induced by bursts and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;high frequencies<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.5 Surges<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9.6 Voltage dips, short interruptions and voltage<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;VARIATIONS<br>&nbsp;&nbsp;&nbsp;&nbsp;6.10 COMBINED STANDARD UNCERTAINTY<br>7. Marking<br>&nbsp;&nbsp;&nbsp;&nbsp;7.1 MEASURING ASSEMBLY<br>&nbsp;&nbsp;&nbsp;&nbsp;7.2 IONIZATION CHAMBER<br>8. ACCOMPANYING DOCUMENTS<br>Table 1 - Minimum EFFECTIVE RANGES<br>Table 2 - REFERENCE VALUES and STANDARD TEST CONDITIONS<br>Table 3 - Number of readings required to detect true <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;differences delta (95 % confidence level) between<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;two sets of instrument readings<br>Table 4 - RELATIVE INTRINSIC ERROR, iota<br>Table 5 - Maximum values for the COEFFICIENT OF VARIATION Vmax<br>Table 6 - LIMITS OF VARIATION for the effects of INFLUENCE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;QUANTITIES<br>Table 7 - Example for assessment of the COMBINED STANDARD <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;UNCERTAINTY<br>Bibliography <br>Index of defined terms

Abstract

Specifies the performance and testing of DOSE AREA PRODUCT METERS with IONIZATION CHAMBERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS. Purpose is: 1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT METERS, and 2) to standardize the methods for the determination of compliance with this level of performance.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62

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