【正文】 quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus Kamp。 ? this collateral standard designates IEC 6060113 alone。 ? 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。 ? 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。20, ISO 497 .......................................39 Annex C (informative) Mapping between this Edition 2 of IEC 6060113 and Edition 1 ........ 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。 ? ―may‖ is used to describe a permissible way to achieve pliance with a requirement or test. Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. Endorsement notice The text of the International Standard IEC 6060113:2020 was approved by CENELEC as a European Standard without any modification. BS EN 6060113:2020 – 4 – CONTENTS INTRODUCTION .................................................................................................................. ... 7 1 Scope, object and related standards .................................................................................8 Scope ..................................................................................................................... . 8 Object .................................................................................................................... .8 Related standards ...................................................................................................8 IEC 606011 ................................................................................................ 8 Particular standards ................................................................................... . 8 2 Normative references ....................................................................................................... 9 3 Terms and definitions ...........................................................