BS EN 60601-2-65:2013
$189.07
Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 48 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 7 | English CONTENTS |
| 8 | INTRODUCTION |
| 9 | 201.1 Scope, object and related standards |
| 11 | 201.2 Normative references 201.3 Terms and definitions |
| 13 | 201.4 General requirements 201.5 General requirements for testing of me equipment 201.6 Classification of me equipment and me systems Table 201.101 – List of potential essential performance to be considered by manufacturer in the risk management process |
| 14 | 201.7 ME equipment identification, marking and documents |
| 16 | 201.8 Protection against electrical hazards from me equipment |
| 17 | 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 |
| 18 | 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 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic compatibility – Requirements and tests |
| 19 | 203 Radiation protection in diagnostic X-ray equipment |
| 29 | Annexes |
| 30 | Annex C (informative) Guide to marking and labeling 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 |
| 31 | Annex AA (informative) Particular guidance and rationale |
| 32 | Figures Figure AA.1 – air kerma during irradiation with direct current x-ray generator |
| 34 | Figure AA.2 – Air kerma during irradiation with onepeak xray generator |
| 35 | Figure AA.3 – Waveform of long irradiation time X-radiation from a onepeak xray generator |
| 38 | Annex BB (informative) Identification of parts of dental X-ray intra-oral systems in relation to defined terms in this standard Figure BB.1 – Structure of dental intra-oral x-ray equipment |
| 39 | Figure BB.2 – Parts of dental intra-oral x-ray equipment |
| 40 | Bibliography |
| 43 | Index of defined terms used in this particular standard |
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