I.S. EN 61223-2-6:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
Hardcopy , PDF
21-10-2022
English
01-01-2007
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 General aspects of CONSTANCY TESTS
4.1 Preconditions
4.2 General conditions affecting test procedures
4.3 Establishment of BASELINE VALUES
4.4 Identification of equipment, instrumentation and test
conditions
4.5 Scope of the CONSTANCY TESTS
4.6 Test equipment, including PHANTOMS and TEST DEVICES
4.7 Frequency of CONSTANCY TESTS
5 Test methods for CT SCANNERS
5.1 Positioning of the PATIENT SUPPORT
5.2 PATIENT positioning accuracy
5.3 TOMOGRAPHIC SECTION THICKNESS
5.4 Dose
5.5 NOISE, UNIFORMITY AND MEAN CT NUMBERS
5.6 SPATIAL RESOLUTION
Annex A (informative) Guidance on action to be taken
Annex B (informative) Alternate test methods for SPATIAL RESOLUTION
Annex C (informative) TOMOGRAPHIC SECTION THICKNESS for helical
scanning
Annex D (informative) Visual method for LOW CONTRAST RESOLUTION
Bibliography
Index of terms
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Describes the essential parameters which describe the performance of CT SCANNERS with regard to image quality, PATIENT dose and positioning; defines the methods of testing the essential parameters; provides criteria to be applied in the evaluation of data for compliance with the tolerances of the parameters specified by the ACCOMPANYING DOCUMENTS and with respect to BASELINE VALUES.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| BS EN 61223-2-6:2007 | Identical |
| IEC 61223-2-6:2006 | Identical |
| EN 61223-2-6:2007 | Identical |
| DIN EN 61223-2-6:2008-12 | Identical |
| UNE-EN 61223-2-6:2008 | Identical |
| NF EN 61223-2-6 : 2007 | Identical |
| SN EN 61223-2-6 : 1994 | Identical |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ISO 5725-3:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method |
| ISO 5725-6:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values |
| ISO 5725-4:1994 | Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method |
| ISO 2092:1981 | Light metals and their alloys Code of designation based on chemical symbols |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| IEC 60601-2-32:1994 | Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
| ASTM E 1695 : 1995 | Standard Test Method for Measurement of Computed Tomography (CT) System Performance |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
| EN 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| IEC 61223-2-4:1994 | Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras |
| IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
| EN 60601-2-44:2009/A2:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016) |
| IEC 61223-2-5:1994 | Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
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