IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. 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 intra-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 intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 7<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 201.1 Scope, object and related standards <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 201.2 Normative references 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 201.4 General requirements 201.5 General requirements for testing of me equipment 201.6 Classification of me\u00a0equipment and me\u00a0systems Table\u00a0201.101 \u2013 List of potential essential performance to be considered by manufacturer in the risk management process <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 201.7 ME equipment identification, marking and documents <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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\u00a0systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic compatibility \u2013 Requirements and tests <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 203 Radiation protection in diagnostic X-ray equipment <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annexes <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Annex C (informative) Guide to marking and labeling requirements for me equipment and me systems Table\u00a0201.C.101 \u2013 Marking on the outside of me equipment or its parts Table\u00a0201.C.102 \u2013 Subclauses requiring statements in accompanying documents <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex AA (informative) Particular guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Figures Figure\u00a0AA.1 \u2013 air kerma during irradiation with direct current x-ray generator <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Figure\u00a0AA.2 \u2013 Air kerma during irradiation with onepeak\u00a0xray\u00a0generator <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Figure\u00a0AA.3 \u2013 Waveform of long irradiation time X-radiation from a onepeak\u00a0xray\u00a0generator <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex BB (informative) Identification of parts of dental X-ray intra-oral systems in relation to defined terms in this standard Figure\u00a0BB.1 \u2013 Structure of dental intra-oral x-ray equipment <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Figure\u00a0BB.2 \u2013 Parts of dental intra-oral x-ray equipment <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 43<\/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 intra-oral X-ray equipment<\/b><\/p>\n |