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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 6<\/td>\n | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 201.1 Scope, object and related standards <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 201.2 Normative references <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 201.3 Terminology and definitions <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 201.4 General requirements <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 201.5 General requirements for testing of me\u00a0equipment 201.6 Classification of me\u00a0equipment and me\u00a0systems 201.7 Me\u00a0equipment identification, marking and documents Tables Table\u00a0201.101 \u2013 List of potential essential performance to be considered by manufacturer in the risk management process <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 201.8 Protection against electrical hazards from me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 201.9 Protection against mechanical hazards of me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 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\u00a0equipment 201.16 Me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 201.17 Electromagnetic compatibility of me\u00a0equipment and me\u00a0systems 202 Electromagnetic compatibility \u2013 Requirements and tests 203 Radiation protection in diagnostic X-ray equipment <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Figures Figure\u00a0203.101 \u2013 Zone of extra-focal radiation <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annexes <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems Table\u00a0201.C.101 \u2013 Marking on the outside of me\u00a0equipment or its parts Table\u00a0201.C.102 \u2013 Subclauses requiring statements in accompanying documents <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex AA (informative) Particular guidance and rationale Figure\u00a0AA.1 \u2013 panoramic x-ray equipment <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure\u00a0AA.2 \u2013 air kerma during irradiation with direct current x-ray generator <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Figure\u00a0AA.3 \u2013 air kerma during irradiation with one-peak x-ray generator <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Figure\u00a0AA.4 \u2013 Example \u2013 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\u00a0AA.5 \u2013 Example \u2013 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 <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Index of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment<\/b><\/p>\n |