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IEC 61303:1994

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Published date

10-12-1994

US$93.00
Excluding Tax where applicable

FOREWORD
Clause
1 General
   1.1 Scope and object
   1.2 Normative references
2 Definitions
3 Measurement of INSTRUMENT ACCURACY
   3.1 Primary test method
   3.2 Secondary test method
4 Measurement Of SYSTEM LINEARITY
   4.1 Primary test methods
   4.2 Secondary test methods
5 Measurement of system reproducibility
   5.1 Primary test method
   5.2 Secondary test method
   5.3 Evaluation
6 Measurement Of AIR-DENSITY CHARACTERISTIC
   6.1 Test method
   6.2 Evaluation
7 Measurement of SAMPLE VOLUME CHARACTERISTIC
   7.1 Test method
   7.2 Evaluation
8 Measurement of background response
   8.1 Inherent background response - Test method
   8.2 Background response to known radiation field -
        Test method
9 Measurement of long-term reproducibility
   9.1 Method for measurements of long-term
        reproducibility
10 Measurement of shielding performance
11 ACCOMPANYING DOCUMENTS and declaration of performance
Annex A - Index of defined terms

Covers radionuclide calibrators of the well type, with a gas-filled ionization chamber as used in the practice of nuclear medicine. The object of this Standard is to identify the most important characteristics of radionuclide calibrators and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardized way and facilitate comparisons between devices. The contents of the corrigendum of June 2016 have been included in this copy.

DevelopmentNote
Stability Date: 2028. (09/2017)
DocumentType
Standard
Pages
29
PublisherName
International Electrotechnical Committee
Status
Current

ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DIN 6855-11:2016-08 CONSTANCY TESTING OF NUCLEAR MEDICINE INSTRUMENTS - PART 11: RADIONUCLIDE CALIBRATORS (IEC/TR 61948-4:2006, MODIFIED)
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
IEC TR 61948-4:2006 Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
PD IEC/TR 61948-4:2007 Nuclear medicine instrumentation. Routine tests Radionuclide calibrators

IEC 61145:1992 Calibration and usage of ionization chamber systems for assay of radionuclides
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms

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