AS/NZS IEC 60601.1.3:2015 pdf download – Medical electrical equipment Part 1.3: General requirements for basic safety and essential performance— Collateral Standard: Radiation protection in diagnostic X-ray equipment.
1 Scope, object and related standards 1 .1 Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS , hereafter referred to as ME EQUIPMENT and ME SYSTEMS . This collateral standard applies to X- RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures. 1 .2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. The object of this collateral standard is to establish general requirements for protection against X- RADIATION in X- RAY EQUIPMENT , in order that the IRRADIATION of the human PATIENT , the OPERATOR , staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the RADIOLOGICAL procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the RISK MANAGEMENT process. This collateral standard considers RADIATION PROTECTION aspects related to X- RADIATION only. Requirements for the control of the electrical energy used to generate X- RADIATION , which is also an important aspect of RADIATION PROTECTION , are included in IEC 60601 -1 and in particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned.
3.6 AMBIENT DOSE EQUIVALENT H*(d) at a point in a RADIATION FIELD , the DOSE EQUIVALENT that would be produced by corresponding expanded and aligned field, in the ICRU sphere at a depth, d, on the radius opposing the direction of the aligned field Unit: J kg –1 The special name for the unit of AMBIENT DOSE EQUIVALENT is sievert (Sv) (ICRU 51 )[1 9] 3.7 ATTENUATION reduction of a RADIATION QUANTITY upon passage of the RADIATION through matter resulting from all types of interaction with this matter NOTE The RADIATION QUANTITY may be, for example, the particle flux density or the energy density. A TTENUATION does not include the geometric reduction of the RADIATION QUANTITY with distance from the RADIATION SOURCE . 3.8 ATTENUATION EQUIVALENT ? thickness of a layer of reference material which, if substituted for the material under consideration in a beam of specified RADIATION QUALITY and under specified geometrical conditions, gives the same degree of ATTENUATION . A TTENUATION EQUIVALENT is expressed in suitable submultiples of the metre together with the reference 3.9 AUTOMATIC CONTROL SYSTEM in an X- RAY EQUIPMENT , system in which the control or limitation of the electric energy delivered to an X- RAY TUBE ASSEMBLY depends upon the measurement of one or more RADIATION QUANTITIES or corresponding physical quantities 3.1 0 AUTOMATIC EXPOSURE CONTROL in an X- RAY EQUIPMENT , MODE OF OPERATION in which one or more LOADING FACTORS are controlled automatically in order to obtain at a pre-selected location a desired quantity of RADIATION 3.1 1 BEAM LIMITING DEVICE device to limit the RADIATION FIELD AS/NZS IEC 60601.1.3:2015 12
3.21 ENTRANCE SURFACE in RADIOLOGY , plane or curved surface through which the RADIATION enters an irradiated object 3.22 EXTRA – FOCAL RADIATION in an X- RAY SOURCE ASSEMBLY , X- RADIATION emitted from the RADIATION SOURCE other than that emitted from the ACTUAL FOCAL SPOT 3.23 FILTER in RADIOLOGICAL EQUIPMENT , material or device provided to effect FILTRATION of the RADIATION BEAM 3.24 FILTRATION modification of characteristics of IONIZING RADIATION on passing through matter NOTE F ILTRATION may be: – preferential ABSORPTION of certain components of polyenergetic X- RADIATION accompanying its ATTENUATION ; – a modification of the distribution of RADIATION intensity over the cross-section of a RADIATION BEAM 3.25 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE distance from the REFERENCE PLANE of an EFFECTIVE FOCAL SPOT to the point at which the REFERENCE AXIS intersects with the image receptor plane 3.26 FOCAL SPOT TO SKIN DISTANCE in MEDICAL DIAGNOSTIC RADIOLOGY , distance from the REFERENCE PLANE of an EFFECTIVE FOCAL SPOT to a plane normal to the REFERENCE DIRECTION and containing the point on the PATIENT surface nearest to the RADIATION SOURCE 3.27 HALF – VALUE LAYER thickness of a specified material, which attenuates under NARROW BEAM CONDITIONS X- RADIATION with a particular spectrum to an extent such that the AIR KERMA RATE , EXPOSURE RATE or ABSORBED DOSE rate is reduced to one half of the value that is measured without the material. The HALF – VALUE LAYER (HVL) is expressed in suitable submultiples of the metre together with the material.