This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: – equipment for RADIOTHERAPY; – equipment for COMPUTED TOMOGRAPHY; – ACCESSORIES intended to be introduced into the PATIENT; – mammographic X-RAY EQUIPMENT; – dental X-RAY EQUIPMENT. NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA. NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements. NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Annex ZA (normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 201.1 Scope, object and related standards <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 201.2 Normative references <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 201.4 General requirements Table 201.101 \u2013 Additional list of potential essential performance to be considered by the manufacturer in the risk management analysis <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 201.5 General requirements for testing me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 201.8 Protection against electrical hazards from me equipment Table 201.102 \u2013 Other subclauses requiring statements in accompanying documents <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 201.9 Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (PEMS) <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 201.15 Construction of me equipment 201.16 ME Systems 201.17 Electromagnetic compatibility of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 202 Electromagnetic disturbances \u2013 Requirements and tests 203 Radiation protection in diagnostic x-ray equipment <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Annexes <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Annex AA (informative) Particular guidance and rationale Table AA.1 \u2013 Examples of prolonged radioscopically guided interventional procedures for which deterministic effects of irradiation are possible <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Table AA.2 \u2013 Examples of radioscopically guided interventional procedures for which deterministic effects are unlikely <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Table AA.3 \u2013 Examples of isodose boundaries and colour codes for skin dose map and air kerma map <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex BB (normative) Distribution maps of stray radiation <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Figure BB.1 \u2013 Example of isokerma map at 100 cm height in lateral configuration <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Figure BB.2 \u2013 Example of isokerma map at 100 cm height in vertical configuration <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | Index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures<\/b><\/p>\n |