IEC 61303:1994
Current
The latest, up-to-date edition.
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
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12-10-1994
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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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