【正文】 United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit233。r die Sicherheit einschlie223。 de base et les performances essentielles Norme collat233。dicaux Partie 13: Exigences g233。ENNE EUROP196。如果買(mǎi)家 需要 PDF 格式的本標(biāo)準(zhǔn)，可以 提供郵箱給我（前提是購(gòu)買(mǎi)了本標(biāo)準(zhǔn)） ，我免費(fèi)發(fā)送到你的郵箱。 BSI 2020 ISBN 978 0 580 54236 7 Amendments/corrigenda issued since publication Date Comments EUROPEAN STANDARD EN 6060113 NORME EUROP201。lectrom233。curit233。t e Teil 13: Allgemeine Festlegungen f252。ntgenger228。i sches Komitee f252。 ? test specifications: in italic type。 ? ―should‖ means that pliance with a requirement or a test is remended but is not mandatory for pliance with this standard。 ? the protective properties of rooms where XRAY EQUIPMENT is installed。 ? the training of staff in the principles of RADIATION PROTECTION and in the correct use of EQUIPMENT, including any PROTECTIVE DEVICES provided. Further advice on these aspects can be found in ICRP Publications 33[15], 34[16], 60[17], 73[18], 85[21], 87[22] and 93[23]. Readers of this collateral standard are reminded that, in accordance with IEC 606011, Clause 5, all the test procedures described are TYPE TESTS, intended to be carried out in a dedicated testing environment in order to determine pliance. Tests to be carried out b y MANUFACTURERS to ensure pliance during production or installation and tests for detecting nonpliance subsequently to delivery, are not included. ————————— 1) Figures in square brackets refer to the Bibliography. BS EN 6060113:2020 – 8 – MEDICAL ELECTRICAL EQUIPMENT – Part 13: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic Xray equipment 1 Scope, object and related standards 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 XRAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures. Object The object of this collateral standard is to specif y 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 XRADIATION in XRAY 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 specif y 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 PRO TECTIO N aspects related to X RADIA TIO N only. Requirements for the control of the electrical energy used to generate XRADIATION, which is also an important aspect of RADIATION PROTECTION, are included in IEC 606011 and in particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned. Related standards IEC 606011 For ME EQUIPMENT and ME SYSTEMS, this collateral standard plements IEC 606011. W hen referring to IEC 606011 or to this collateral standard, either individually or in bination, the following conventions are used: ? the general standard designates IEC 606011 alone。 = dK dt Unit: J kg–1 s–1 If the special name gray is used, the unit of AIR KERMA RATE is gray per second (Gy s–1) (ICRU 60) [20] [IEC 60580:2020, definition ] [8] AM BIENT DOSE EQUIV ALENT 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)[19] ATTENU ATION reduction of a RADIATION QUANTITY upon passage of the RADIATION through matter resulting from all types of interaction with this matter NOTE The RAD I A T I ON QUA NTITY may be, for example, the particle flux density or the energy density. AT T ENU AT I O N does not include the geometric reduction of the RADIA TION QUANTITY with distance from the RADIA TION SOURCE. ATTENUATION EQUIV ALENT δ 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. ATTENUATION EQUIVALENT is expressed in suitable submultiples of the metre together with the reference AUTOM ATIC CONTROL SYSTEM in an XRAY EQUIPMENT, system in which the control or limitation of the electric energy delivered to an XRAY TUBE ASSEMBLY depends upon the measurement of one or more RADIATION QUANTITIES or corresponding physical quantities AUTOM ATIC EXPOSURE CONTROL in an XRAY EQUIPMENT, MODE OF OPERATION in which one or more LOADING FACTORS are controlled automatically in order to obtain at a preselected location a desired quantity of RADIATION BE AM LIMITING DEVICE device to limit the RADIATION FIELD – 11 – BS EN 6060113:2020 BE AM LIMITING SYSTEM enti