IEC 61223-3-1:1999 pdf download.Evaluation and routine testing in medical imaging departments – Part 3-1: Acceptance tests – Imaging performance of X-ray equipment for radiographic and radioscopic systems
1 Scope and object
1.1 Scope
This part of IEC 61 223 applies to those components of X- RAY EQUIPMENT which influence the image quality and PATIENT dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems.
This standard applies to the performance of X- RAY EQUIPMENT in the ACCEPTANCE TEST on the following medical diagnostic X- RAY EQUIPMENT and ASSOCIATED EQUIPMENT :
– radiography equipment, for example:
– stationary radiography EQUIPMENT ;
– mobile radiography EQUIPMENT ;
– skull radiography EQUIPMENT ;
– lung radiography EQUIPMENT ;
–TOMOGRAPHY EQUIPMENT – excluding COMPUTED TOMOGRAPHY ;
– radiography devices ( SPOTFILM DEVICES ) in RADIOSCOPY EQUIPMENT ;
–angiography EQUIPMENT (excluding DSA function);
–CINERADIOGRAPHY equipment;
– RADIOSCOPY EQUIPMENT ,
– including:
– combined radiographic and radioscopic EQUIPMENT .
This standard applies to the generation of X- RADIATION and ACCESSORIES of digital systems. It does not apply to any digital image acquisition or image processing parts of the above mentioned diagnostic X- RAY EQUIPMENT .
NOTE – Since the characterization of digital detectors and image processing is still under development, this will be included in a later edition of this standard.
This standard does not apply to mammographic X- RAY EQUIPMENT , RADIOTHERAPY simulators,
nor to dental X- RAY EQUIPMENT .
1.2 Object
This standard defines:
a) the parameters which describe the performance of X- RAY EQUIPMENT with regard to imaging
properties and PATIENT dose;
b) methods of testing whether measured quantities related to those parameters comply with
the specified tolerances.
These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during or after the installation is completed. Signed statements covering steps of product testing at the MANUFACTURER ‘s site or during the installation procedure can be used as part of the acceptance testing. The aim is to verify compliance of the installation with specifications relating to the image quality and PATIENT dose, and to detect malfunctions that are not in agreement with those specifications. This standard does not specify tolerances for the parameters under investigation. Nor does it consider: c) aspects of mechanical and electrical safety, d) aspects of mechanical, electrical and software performance unless they are essential to the performance of the tests directly affecting image quality and PATIENT dose.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently valid International Standards.
IEC 60336:1 993, X-ray tube assemblies for medical diagnosis – Characteristics of focal spots
IEC 6041 7-1 :1 998, Graphical symbols for use on equipment – Part 1 : Overview and application
IEC 60522:1 976, Inherent filtration of an X-ray tube assembly
IEC 60580:1 977, Area exposure product meter
IEC 60601 -1 :1 988, Medical electrical equipment – Part 1 : General requirements for safety
IEC 60601 -1 -3:1 994, Medical electrical equipment – Part 1 : General requirements for safety –
3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601 -2-7:1 998, Medical electrical equipment – Part 2: Particular requirements for the
safety of high-voltage generators of diagnostic X-ray generators
IEC 60601 -2-28:1 993 , Medical electrical equipment – Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60788:1 984, Medical radiology – Terminology
IEC 60878:1 988, Graphical symbols for electrical equipment in medical practice
IEC 61 223-1 :1 993, Evaluation and routine testing in medical imaging departments – Part 1 :
General aspects
IEC 61 267:1 994, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
ISO 2092:1 981 , Light metals and their alloys – Code of designation based on chemical symbols
IEC 61223-3-1:1999 pdf download
