IEC IEC60601-1-3 Edition 2.12013-04 INTERNATIONAL STANDARD NORME INTERNATIONALE colour inside Medical electrical equipment- Part 1-3:General requirementsforbasicsafety and essential performance Collateral Standard:Radiation protection in diagnosticX-ray equipment Appareilselectromedicaux- Partie1-3:Exigencesgeneralespourlasecurite debase et lesperformances essentielles-Normecollaterale:Radioprotection danslesappareilsa rayonnementXde diagnostic dayuwen
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IEC IEC60601-1-3 Edition 2.12013-04 INTERNATIONAL STANDARD NORME INTERNATIONALE colour inside Medicalelectricalequipment- Part1-3:Generalrequirementsforbasicsafety andessentialperformance CollateralStandard:RadiationprotectionindiagnosticX-rayequipment Appareils electromedicaux- Partie1-3:Exigences generalespour la securite de base et les performances essentielles-Norme collaterale:Radioprotection danslesappareilsa rayonnementXdediagnostic INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.50; 13.280 ISBN 978-2-8322-0765-9 Warning! Make sure that you obtained this publication from an authorized distributor. Wwdayuvenku.大宇文库
-2- 60601-1-3 ○IEC:2008A1:2013 CONTENTS FOREWORD. .5 INTRODUCTION.. 8 INTRODUCTIONTOAMENDMENT1 .9 Scope object and related standards. .10 1.1 Scope. ..10 1.2 Object. .10 1.3 Related standards .10 1.3.1 IEC 60601-1 ...10 1.3.2 Particular standards ..10 2 Normative references ...1 3 Terms and definitions ..11 General requirements ..21 4.1 Statement of pliance 21 4.2 Composition of reference materials .21 5 ME EQuIPMENT identification marking and documents 21 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .21 5.1.1 General .21 5.1.2 Marking requirements in subclauses. ..1 5.2 ACCOMPANYING DOCUMENTS. .21 5.2.1 References in subclauses. .22 5.2.2 Dosimetric calibration 22 5.2.3 General requirements for the reference of subassemblies and ACCESSORIES. 22 5.2.4 Instructions for use.. .23 6 RADIATION management. ..24 6.1 General .24 6.2 Initiation and termination of the IRRADIATION 25 6.2.1 Normal initiation and termination of the IRRADIATION.. .25 6.2.2 Safety measures against failure of normal termination of the IRRADIATION..... .25 6.3 RADIATION dose and RADIATION QUALITY. .25 6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY 25 6.3.2 Reproducibility of the RADIATION output. .25 6.4 Indication of operational states... .26 6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected .26 6.4.2 Indication of LOADING STATE .26 6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION.. 26 6.4.4 Indication of automatic modes.... .26 6.4.5 Dosimetric indications.... ..27 6.5 AUTOMATIC CONTROL SYSTEM.. .27 6.6 SCATTERED RADIATION reduction . ..27 6.7 Imaging performance. 27 6.7.1 General 27 6.7.2 System performance... .27 6.7.3 Nominal focal spot value. ..28 dayuvenku.大宇文库
60601-1-3 IEC:2008A1:2013 6.7.4RADIATION DETECTOR or X-RAY IMAGE RECEPTOR .28 RADIATION QUALITY. ..28 7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT 28 Waveform of the X-RAY TUBE VOLTAGE. 29 7.3 Indication of FILTER properties ..29 7.4 Test for FILTRATION by irremovable materials 7.5 Test for ADDED FILTERS and materials.. ...30 7.6 Test for HALF-VALUE LAYER .30 8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD and IMAGE RECEPTION AREA .30 8.1 General. ..30 8.2 Enclosure of X-RAY TUBES. 30 8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES . .31 8.4 Confinement of EXTRA-FOCAL RADIATION .31 8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA .... ...31 8.5.1 General ...31 8.5.2 *FOCAL SPOT TO IMAGE RECEPTOR DISTANCE... ..31 8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA... .31 8.5.4 Positioning of the PATIENT and restriction of the irradiated area. 32 9 FOCAL SPOT TO SKIN DISTANCE. ...32 9.1 General. 32 9.2 Information in the ACCOMPANYING DOCUMENTS ...32. 10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR ... .32 10.1 General 32 10.2 Information in the ACCOMPANYING DOCUMENTS .32 11Protection against RESIDUAL RADIATION. ..3 12 * Protection against LEAKAGE RADIATION . ...3. 12.1 General .33 12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS . 12.3 Statement of reference LoADING conditions. ..34 12.4 LEAKAGE RADIATION in the LOADING STATE ..34 12.5 LEAKAGE RADIATION when not in the LOADING STATE 13 Protection against STRAY RADIATION ..35 13.1 General. ..35 13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA. ..5 13.3 Protection by distance. 36 13.4 Designated SIGNIFICANT ZONES OF OCCUPANCY .36 13.5 Handgrips and control devices .37 13.6*Test for STRAY RADIATION ..37 Annex A (informative) General guidance and rationale. 39 Annex B (normative) Values of the series R'10 and R'20 1SO 497 .41 Annex C(informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1....42 Bibliography.. 44 dayuwenku.大宇文库
IEC 60601-1-3-2013 医用电气设备 第1-3部分 基本安全和基本性能的一般要求一附带标准诊断X射线设备的辐射防护.pdf
