【正文】
e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60336, Medical electrical equipment – Xray tube assemblies for medical diagnosis Characteristics of focal spots IEC 60522:1999, Determination of the permanent filtration of Xray tube assemblies IEC 606011:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60788:2020, Medical electrical equipment – Glossary of defined terms ISO 497, Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 606011:2020, IEC 60788:2020 and the following apply. NOTE An index of defined terms is found beginning on page 45. ACCESSIBLE SURF ACE surface of EQUIPMENT or of an EQUIPMENT part that can be easily or accidentally touched by persons without the use of a TOOL ADDED FILTER removable or irremovable FILTER positioned in the RADIATION BEAM to provide part or all of the ADDITIONAL FILTRATION ADDITIONAL FILTRATION QUALITY EQUIVALENT FILTRATION due to ADDED FILTERS and other removable materials in the RADIATION BEAM which are between the RADIATION SOURCE and the PATIENT or a specified plane AIR KERM A K quotient of dEtr by dm, where dEtr is the sum of the initial kiic energies of all the charged particles liberated by uncharged particles in a mass dm of air, thus K = dEtr dm Unit: J kg–1 The special name for the unit of AIR KERMA is gray (Gy) (ICRU 60) [20] [IEC 60580:2020, definition , modified] [8] BS EN 6060113:2020 – 10 – AIR KERM A RATE Kamp。 ? the need in appropriate circumstances for PROTECTIVE CLO THING to be worn by staff and for suitable devices to be used to protect PATIENTS。 ? TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, the term – ―clause‖ means one of the thirteen numbered divisions within the table of contents, inclusive of all subdivisions (. Clause 7 includes Subclauses , , etc.)。 Europ233。rale: Radioprotection dans les appareils 224。ISCHE NORM April 2020 ICS 。 BS EN 6060113:2020 National foreword This British Standard is the UK implementation of EN 6060113:2020. It is identical to IEC 6060113:2020. It supersedes BS EN 6060113:1995, which will be declared obsolescent and will be withdrawn on publication of the revised BS EN 606012 series. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Submittee CH/62/2, Diagnostic imaging equipment. A list of anizations represented on this mittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority Strate gy Committee on 30 Septem ber 2020 169。rales pour la s233。n zungsnorm: Strahlenschutz von diagnostischen R246。 or – a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (. alarm systems). In this collateral standard, the following print types are used: ? requirements and definitions: in roman type。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