BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 General aspects of the ACCEPTANCE TEST
5 General aspects of CONSTANCY TESTS
6 Summary of tests for MAMMOGRAPHIC TOMOSYNTHESIS
   equipment
7 Inventory and Initial Tests for MAMMOGRAPHIC
   TOMOSYNTHESIS equipment
8 Alignment and collimation checks
9 AEC-system
10 Image receptor
11 Image quality of the reconstructed image
12 Missed tissue
13 Homogeneity of the reconstructed tomosynthesis
   image
14 Dosimetry for digital breast tomosynthesis
Annex A (informative) - Tables for dosimetry calculation
        in digital breast tomosynthesis
Annex B (informative) - Guidance on action to be taken
Annex C (informative) - Bibliography
Annex D (informative) - Image Quality Evaluation

BS EN 61223-3-6.

Committee	CH/62
DocumentType	Draft
Pages	49
PublisherName	British Standards Institution
Status	NA

IEC 60336:2005	Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 61674:2012	Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004	Medical electrical equipment - Glossary of defined terms
IEC 62220-1-2:2007	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
IEC 62563-1:2009+AMD1:2016 CSV	Medical electrical equipment - Medical image display systems - Part1: Evaluation methods
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
IEC 60601-2-28 : 3.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
IEC 60601-1-3:2008+AMD1:2013 CSV	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 61223-3-2:2007	Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
IEC 60627:2013	Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
IEC 61676:2002+AMD1:2008 CSV	Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
IEC 61223-2-4:1994	Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras
EN 573-3:2013	Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products
IEC 60601-2-45:2011+AMD1:2015 CSV	Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
IEC 61223-2-5:1994	Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices