IEC 61223-3-4 pdf download.Evaluation and routine testing in medical imaging departments
1 Scope and object
1 .1 Scope This part of IEC 61 223 applies to those components of dental X- RAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose. This standard applies to the performance of the ACCEPTANCE TEST on dental X- RAY EQUIPMENT with intra-oral X- RAY IMAGE RECEPTOR and dental X- RAY EQUIPMENT with extra-oral X- RAY IMAGE RECEPTOR (for example, dental panoramic X- RAY EQUIPMENT or cephalometric X- RAY ). This standard applies to dental film and digital image acquisition and processing. 1 .2 Object This standard defines a) the essential parameters which describe the performance of the above-mentioned dental X- RAY EQUIPMENT with regard to imaging properties and PATIENT dose; b) methods of testing and 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 in the installation procedure may be used as part of the acceptance testing. The aim is to verify compliance of the installation with specifications affecting the image quality and PATIENT dose, and to detect malfunctions that are not in agreement with those specifications. This standard does not in itself specify tolerances for the parameters under investigation. Neither is it intended to 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 part of IEC 61 223. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of IEC 61 223 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 6041 7-2:1 998, Graphical symbols for use on equipment – Part 2: Symbol originals IEC 60522:1 999, Determination of the permanent filtration of X-ray tube assemblies IEC 60601 -1 :1 988, Medical electrical equipment – Part 1 : General requirements for safety IEC 60601 -2-28:1 993, Medical electrical equipment – Part 2-28: 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
3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions in IEC 60601 -1 , in IEC 60788, in IEC 61 223-1 , or in this standard. NOTE Attention is drawn to the fact that in cases where the concept addressed is not strongly confined to the definition given in one of the publications listed above, a corresponding term is printed in lower-case letters. An index of defined terms used in this standard is given in annex A. 3.3 Defined terms For the purpose of this part of IEC 61 223, the following additional definitions apply. 3.3.1 ARTEFACT apparent structure visible in the image which does not represent a structure within the object. 3.3.2 LINE PAIR RESOLUTION highest spatial frequency of the specified line-group test pattern imaged under specified conditions which is distinguishable in the image. The unit is lp/mm. NOTE Another term for LINE PAIR RESOLUTION used in literature is spatial resolution. 3.3.3 LOW CONTRAST RESOLUTION the lowest contrast detail object of a specified object that can be resolved from a uniform background. 3.3.4 RADIATION OUTPUT AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in the primary X- RAY BEAM.