IEC 60601-1-3-2008 Medical electrical equipment - Part 1-3 General requirements for basic safety and essential performance - Collateral standard Radiation prote.pdf

1、 IEC 60601-1-3Edition 2.0 2008-01INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment Appareils lectromdicaux Partie 1-3: Exigences gnr

2、ales pour la scurit de base et les performances essentielles Norme collatrale: Radioprotection dans les appareils rayonnement X de diagnostic IEC60601-1-3:2008 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of

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17、ORME INTERNATIONALEMedical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment Appareils lectromdicaux Partie 1-3: Exigences gnrales pour la scurit de base et les performances essentiel

18、les Norme collatrale: Radioprotection dans les appareils rayonnement X de diagnostic INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XICS 11.040.50; 13.280 PRICE CODECODE PRIXISBN 2-8318-9541-3 2 60601-1-3 IEC:2008 CONTENTS FOREWORD.5 INTRODUCTION.8 1 Scope, obje

19、ct and related standards.9 1.1 Scope9 1.2 Object .9 1.3 Related standards .9 1.3.1 IEC 60601-1 9 1.3.2 Particular standards 9 2 Normative references .10 3 Terms and definitions .10 4 General requirements.20 4.1 Statement of compliance .20 4.2 Composition of reference materials .20 5 ME EQUIPMENT ide

20、ntification, marking and documents .20 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 20 5.1.1 General .20 5.1.2 Marking requirements in subclauses20 5.2 ACCOMPANYING DOCUMENTS20 5.2.1 References in subclauses21 5.2.2 Dosimetric calibration 21 5.2.3 General requirements for the ref

21、erence of subassemblies and ACCESSORIES21 5.2.4 Instructions for use22 6 RADIATION management23 6.1 General .23 6.2 Initiation and termination of the IRRADIATION 24 6.2.1 Normal initiation and termination of the IRRADIATION.24 6.2.2 Safety measures against failure of normal termination of the IRRADI

22、ATION24 6.3 RADIATION dose and RADIATION QUALITY24 6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY 24 6.3.2 Reproducibility of the RADIATION output 24 6.4 Indication of operational states25 6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected 25 6.4.2 Indication of LOADING STATE .25 6.4.3

23、 Indication of LOADING FACTORS and MODES OF OPERATION25 6.4.4 Indication of automatic modes .25 6.4.5 Dosimetric indications26 6.5 AUTOMATIC CONTROL SYSTEM 26 6.6 SCATTERED RADIATION reduction.26 6.7 Imaging performance.26 6.7.1 General .26 6.7.2 System performance26 6.7.3 Nominal focal spot value27

24、 6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR 27 7 RADIATION QUALITY 27 60601-1-3 IEC:2008 3 7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT .27 7.2 Waveform of the X-RAY TUBE VOLTAGE28 7.3 Indication of FILTER properties .28 7.4 Test for FILTRATION by irremovable materials .29 7.5

25、 Test for ADDED FILTERS and materials.29 7.6 Test for HALF-VALUE LAYER .29 8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD and IMAGE RECEPTION AREA .29 8.1 General .29 8.2 Enclosure of X-RAY TUBES29 8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES .30 8.4 Confinement

26、 of EXTRA-FOCAL RADIATION .30 8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA .30 8.5.1 General .30 8.5.2 * FOCAL SPOT TO IMAGE RECEPTOR DISTANCE 30 8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA .30 8.5.4 Positioning of the PATIENT and restriction of the i

27、rradiated area31 9 FOCAL SPOT TO SKIN DISTANCE31 9.1 General .31 9.2 Information in the ACCOMPANYING DOCUMENTS 31 10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR .31 10.1 General .31 10.2 Information in the ACCOMPANYING DOCUMENTS 31 11 Protection against RESIDUAL RA

28、DIATION32 12 * Protection against LEAKAGE RADIATION 32 12.1 General .32 12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS 32 12.3 Statement of reference LOADING conditions33 12.4 LEAKAGE RADIATION in the LOADING STATE .33 12.5 LEAKAGE RADIATION when not in the LOADING STATE 34

29、13 Protection against STRAY RADIATION 34 13.1 General .34 13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA34 13.3 Protection by distance .35 13.4 * Designated SIGNIFICANT ZONES OF OCCUPANCY .35 13.5 Handgrips and control devices 36 13.6 * Test for STRAY RADIATION.36 Annex A (informative) Genera

30、l guidance and rationale.38 Annex B (normative) Values of the series R10 and R20, ISO 497.40 Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 141 Bibliography43 Index of defined terms used in this collateral standard45 4 60601-1-3 IEC:2008 Figure 1 Example of present

31、ation of data on STRAY RADIATION37 Table 1 Subclauses containing requirements for marking.20 Table 2 Subclauses requiring statements in ACCOMPANYING DOCUMENTS.21 Table 3 HALF-VALUE LAYERS in X-RAY EQUIPMENT.28 60601-1-3 IEC:2008 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPM

32、ENT Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnic

33、al committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, T

34、echnical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, gover

35、nmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions o

36、r agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for internationa

37、l use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to

38、promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly i

39、ndicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall att

40、ach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fee

41、s) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publicati

42、on. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-1-3 has been prepared by IEC subcommittee 62B: Diagnos

43、tic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition constitutes a collateral standard to IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance hereafter referred to as the gene

44、ral standard. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION

45、PROTECTION that apply to all diagnostic X-RAY 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. 6 60601-1-3 IEC:2008 The text of this collateral standard is based on th

46、e following documents: FDIS Report on voting 62B/673/FDIS 62B/683/RVDFull information on the voting for the approval of this collateral standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In

47、the 60601 series of publications, collateral standards specify general requirements for safety applicable to: a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g.

48、alarm systems). In this collateral standard, the following print types are used: requirements and definitions: roman type. test specifications: italic type. informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in

49、a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: 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 (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.