BS EN 60601-1-3:2008+A11:2016
$198.66
Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 56 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | European foreword |
| 7 | 1 Modifications to annexes Annex ZA (normative) Normative references to international publications with their corresponding European publications |
| 8 | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives |
| 12 | English CONTENTS |
| 15 | INTRODUCTION |
| 16 | 1 Scope, object and related standards 1.1 Scope 1.2 Object 1.3 Related standards |
| 17 | 2 Normative references 3 Terms and definitions |
| 27 | 4 General requirements 4.1 Statement of compliance 4.2 Composition of reference materials 5 Me equipment identification, marking and documents 5.1 Marking on the outside of me equipment or me equipment parts 5.2 Accompanying documents Table 1 – Subclauses containing requirements for marking |
| 28 | Table 2 – Subclauses requiring statements in accompanying documents |
| 30 | 6 Radiation management 6.1 General |
| 31 | 6.2 Initiation and termination of the irradiation 6.3 Radiation dose and radiation quality |
| 32 | 6.4 Indication of operational states |
| 33 | 6.5 Automatic control system 6.6 Scattered radiation reduction 6.7 Imaging performance |
| 34 | 7 Radiation quality 7.1 Half-value layers and total filtration in X-ray equipment |
| 35 | 7.2 Waveform of the X-ray tube voltage 7.3 Indication of filter properties Table 3 – Half-value layers in X-ray equipment |
| 36 | 7.4 Test for filtration by irremovable materials 7.5 Test for added filters and materials 7.6 Test for half-value layer 8 Limitation of the extent of the X-ray beam and relationship between X-ray field and image reception area 8.1 General 8.2 Enclosure of X-ray tubes |
| 37 | 8.3 Limiting diaphragm in X-ray tube assemblies 8.4 Confinement of extra-focal radiation 8.5 Relationship between X-ray field and image reception area |
| 38 | 9 Focal spot to skin distance 9.1 General 9.2 Information in the accompanying documents 10 Attenuation of the X-ray beam between the patient and the X-ray image receptor 10.1 General 10.2 Information in the accompanying documents |
| 39 | 11 Protection against residual radiation 12 * Protection against leakage radiation 12.1 General 12.2 Mounting of X-ray source assemblies and X-ray imaging arrangements |
| 40 | 12.3 Statement of reference loading conditions 12.4 Leakage radiation in the loading state |
| 41 | 12.5 Leakage radiation when not in the loading state 13 Protection against stray radiation 13.1 General 13.2 Control of X-ray equipment from a protected area |
| 42 | 13.3 Protection by distance 13.4 * Designated significant zones of occupancy |
| 43 | 13.5 Handgrips and control devices 13.6 * Test for stray radiation |
| 44 | Figure 1 – Example of presentation of data on stray radiation |
| 45 | Annex A (informative) General guidance and rationale |
| 47 | Annex B (normative) Values of the series R’10 and R’20, ISO 497 Table B.1 – Values of the series R’10 and R’20, ISO 497 |
| 48 | Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1 |
| 50 | Bibliography |
| 52 | Index of defined terms used in this collateral standard |
