【正文】 ? this standard designates the bination of the general standard and this collateral standard. Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard. – 9 – BS EN 6060113:2020 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the 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。10 and R39。 ? 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.)。 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 6060113:2020 E BS EN 6060113:2020 – 2 – Foreword The text of document 62B/673/FDIS, future edition 2 of IEC 6060113, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IECCENELEC parallel vote and was approved by CENELEC as EN 6060113 on 20200301. The following date was fixed: – latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 20201201 This European Standard supersedes EN 6060113:1994. However, EN 6060113:1994 remains valid until all the Parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national standards (dow) has therefore been fixed. However, when Part 13 is used for appliances not covered by a Part 2, EN 6060113:1994 is not to be used after 20200912. This EN 6060113 has been restructured and aligned to EN 606011:2020 and focussed on general requirements for RADIA TION PROTECTION that apply to all diagnostic XRAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C. This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 606011:2020, hereafter referred to as the general standard. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: – a subgroup of MEDICAL ELECTRICAL EQUIPMENT (. RADIOLOGICAL equipment)。 Europ233。lich der wesentlichen Leistungsmerkmale Erg228。rale: Radioprotection dans les appareils 224。n233。ISCHE NORM April 2020 ICS 。 標 標 準 王 國 網(wǎng) 標準 下載地址 BRITISH STANDARD BS EN 6060113:2020 Medical electrical equipment — Part 13: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic Xray equipment 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 pract