【正文】 n 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。如果買家 需要 PDF 格式的本標準，可以 提供郵箱給我（前提是購買了本標準） ，我免費發(fā)送到你的郵箱。 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 。 BSI 2020 ISBN 978 0 580 54236 7 Amendments/corrigenda issued since publication Date Comments EUROPEAN STANDARD EN 6060113 NORME EUROP201。ISCHE NORM April 2020 ICS 。lectrom233。n233。curit233。rale: Radioprotection dans les appareils 224。t e Teil 13: Allgemeine Festlegungen f252。lich der wesentlichen Leistungsmerkmale Erg228。ntgenger228。 Europ233。i sches Komitee f252。 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 However, EN 6060113:1994 remains valid until all the Parts 2 that are used in conjunction with it have been withdrawn.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)。 ? test specifications: in italic type。 ? 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.)。 ? ―should‖ means that pliance with a requirement or a test is remended but is not mandatory for pliance with this standard。10 and R39。 ? the protective properties of rooms where XRAY EQUIPMENT is installed。 ? 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 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