BS EN 60601-2-63:2015
$198.66
Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 52 |
IEC 60601-2-63:2012 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: – the x-ray tube assembly contains the high-voltage transformer assembly; and – the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives |
| 7 | English CONTENTS |
| 9 | FOREWORD |
| 12 | INTRODUCTION |
| 13 | 201.1 Scope, object and related standards |
| 15 | 201.2 Normative references |
| 16 | 201.3 Terminology and definitions |
| 17 | 201.4 General requirements |
| 18 | 201.5 General requirements for testing of me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents Tables Table 201.101 – List of potential essential performance to be considered by manufacturer in the risk management process |
| 21 | 201.8 Protection against electrical hazards from me equipment |
| 22 | 201.9 Protection against mechanical hazards of me equipment and me systems |
| 23 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.16 Me systems |
| 24 | 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic compatibility – Requirements and tests 203 Radiation protection in diagnostic X-ray equipment |
| 33 | Figures Figure 203.101 – Zone of extra-focal radiation |
| 36 | Annexes |
| 37 | Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems Table 201.C.101 – Marking on the outside of me equipment or its parts Table 201.C.102 – Subclauses requiring statements in accompanying documents |
| 38 | Annex AA (informative) Particular guidance and rationale Figure AA.1 – panoramic x-ray equipment |
| 40 | Figure AA.2 – air kerma during irradiation with direct current x-ray generator |
| 41 | Figure AA.3 – air kerma during irradiation with one-peak x-ray generator |
| 42 | Figure AA.4 – Example – series of (numerous) pulsed irradiations for a CBCT (cone beam computed tomography) irradiation event, with constant potential high-voltage generator and time-width modulation Figure AA.5 – Example – series of two irradiations for panoramic-like views of right and left TMJ (temporo-mandibolar joint) in the same image, with one-peak high-voltage generator |
| 44 | Bibliography |
| 47 | Index of defined terms used in this particular standard |
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