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

Amended by

IEC 61303:1994/COR1:2016

Available format(s)

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

Published date

10-12-1994

Publisher

International Electrotechnical Committee

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

Standards	Relationship
NF EN 61303 : 1995	Identical
GOST IEC 61303 : 2011	Identical
NEN 11303 : 1995	Identical
I.S. EN 61303:1996	Identical
PN EN 61303 : 2002 AC 2017	Identical
AS/NZS 4354:1995	Identical
SN EN 61303 : 1995	Identical
UNE-EN 61303:1997/AC:2016-07	Identical
BS EN 61303:1997	Identical
UNE-EN 61303:1997	Identical
EN 61303:1995/AC:2016-07	Identical
DIN EN 61303:1996-03	Identical
GOST R IEC 61303 : 1999	Identical

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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IEC 61303:1994

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