【正文】 ....... 40 Annex ZA (normative) Normative references to international publications with their corresponding European publications .................................................................... 48 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives ................... 49 B ibliography.................................................................................................................. ........ 42 Index of defined terms used in this collateral standard .......................................................... 44 BS EN 6060113:2020 – 6 – Figure 1 – Example of presentation of data on STRAY RADIATION ............................................ 36 Table 1 – Subclauses containing requirements for marking ................................................... 19 Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS ............................. 20 Table 3 – HALFVALUE LAYERS in XRAY EQUIPMENT ................................................................. 27 – 7 – BS EN 6060113:2020 INTRODUCTION The requirements in this collateral Standard concern protective measures to be taken by the MANUFACTURER in the design and construction of medical diagnostic XRAY EQUIPMENT and its subassemblies. They relate to the application of the XRADIATION generated, both deliberately and incidentally, in fulfilling the medical purpose of the EQUIPMENT. Additional measures are necessary to regulate the generation processes themselves. These are described in the general requirements for safety, IEC 606011, and, where appropriate, in particular requirements for the EQUIPMENT concerned. The second edition of this collateral standard is focused on general requirements for RADIATION PROTECTION. The aim of the revision was to restrict to those requirements that apply to all diagnostic XRAY EQUIPMENT. In consequence, most of the clauses have been reduced pared with the first edition of this standard, owing to the exclusion of content specific to projection RADIOGRAPHY and RADIOSCOPY. Implementation shall be considered in the RISK MANAGEMENT process or by using particular standards. The remended principles governing the use of RADIATION for medical purposes, as stated in Publication 60 of the International Commission on Radiological Protection (ICRP )[17] 1), Chapter 4, have been taken into account. The implementation of these principles is essentially determined in the prevailing circumstances at the point of use. It requires judgements to be made by the user and the establishment of measures and working practices part of which are connected with the construction of EQUIPMENT. The requirements in this collateral Standard are intended to be consistent with generally accepted good practice in the administration of XRADIATION in medicine. In some cases, the formulation of the requirements is deliberately designed to provide scope for acmodating local laws and regulations at the time of installation and missioning. Several of the requirements include provisions for relevant technical information to be included in ACCOMPANYING DOCUMENTS. RESPONSIBLE ORGANIZATIONs for medical diagnostic XRAY EQUIPMENT should be aware that effective protection against IONIZING RADIA TIO N requires the consideration of many aspects additional to the construction of the EQUIPMENT. Among these are the following: ? patibility of ponents and correct installation of EQUIPMENT。 ? the protective properties of rooms where XRAY EQUIPMENT is installed。 ? measures for monitoring and maintaining the safety and effectiveness of EQUIPMENT throughout its life, with particular attention to ponents that can deteriorate progressively with time and use。 ? the need in appropriate circumstances for PROTECTIVE CLO THING to be worn by staff and for suitable devices to be used to protect PATIENTS。 ? the keeping of appropriate records concerning the usage of the EQUIPMENT and the results of tests, with systematic review and the application of corrective action when necessary。 ? 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