IEC 62494-1:2008
Current
The latest, up-to-date edition.
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French, Spanish, Castilian
13-08-2008
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Creation of ORIGINAL DATA
4.2 Determination of the RELEVANT IMAGE REGION and the
VALUE OF INTEREST
4.3 Requirements for the EXPOSURE INDEX
4.4 Calibration of the EXPOSURE INDEX
4.5 Determination of the CALIBRATION FUNCTION
4.6 Determination of the INVERSE CALIBRATION FUNCTION
4.7 Requirements for the DEVIATION INDEX
Annex A (informative) Details on the rationale, properties
and use of the EXPOSURE INDEX
Annex B (informative) Details on the rationale, properties
and use of the DEVIATION INDEX
Annex C (normative) Beam conditions to be used for calibration
Bibliography
Terminology - Index of defined terms
IEC 62494-1:2008 specifies definitions and requirements for the exposure index of images acquired with digital X-ray imaging systems. IEC 62494-1:2008 is applicable to digital X-ray imaging systems used in general radiography for producing projection X-ray images for general applications, such as, but not exclusively:
- computed radiography (CR) systems based on stimulable phosphors;
- flat-panel detector based systems;
- charge-coupled device (CCD) based systems.
Image intensifier based systems and systems for mammographic or dental application are not covered in this first edition. IEC 62494-1:2008 defines the exposure index only for images generated with a single irradiation event. Images generated from multiple irradiations (e.g., tomosynthetic or dual-energy images, multiple views on a single CR plate) are not covered.
| Committee |
TC 62/SC 62B
|
| DevelopmentNote |
Stability Date: 2020. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Standards | Relationship |
| GOST R IEC 62494-1 : 2013 | Identical |
| NEN EN IEC 62494-1 : 2008 | Identical |
| I.S. EN 62494-1:2008 | Identical |
| PN EN 62494-1 : 2009 | Identical |
| UNE-EN 62494-1:2009 | Identical |
| BS EN 62494-1:2008 | Identical |
| CEI EN 62494-1 : 2010 | Identical |
| EN 62494-1:2008 | Identical |
| NF EN 62494-1 : 2009 | Identical |
| DIN EN 62494-1:2010-05 | 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 |
| 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 |
| NEMA PS3.3 : 2017A | DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS |
| 17/30341818 DC : 0 | BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| ISO/IEC Guide 98:1993 | Guide to the expression of uncertainty in measurement (GUM) |
| 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 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| ISO 9236-1:2004 | Photography Sensitometry of screen/film systems for medical radiography Part 1: Determination of sensitometric curve shape, speed and average gradient |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
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