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BS EN 60601-2-43:2022:2023 Edition

BS EN 60601-2-43:2022:2023 Edition

$198.66

Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Published By Publication Date Number of Pages
BSI 2023 70
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Annex ZA (normative)Normative references to international publicationswith their corresponding European publications
10 Blank Page
11 English
CONTENTS
12 FOREWORD
15 INTRODUCTION
16 201.1 Scope, object and related standards
18 201.2 Normative references
19 201.3 Terms and definitions
20 201.4 General requirements
Table 201.101 – Additional list of potential essential performance to be considered by the manufacturer in the risk management analysis
22 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
26 201.8 Protection against electrical hazards from me equipment
Table 201.102 – Other subclauses requiring statements in accompanying documents
27 201.9 Protection against mechanical hazards of me equipment and me systems
28 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
30 201.12 Accuracy of controls and instruments and protection against hazardous outputs
33 201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (PEMS)
34 201.15 Construction of me equipment
201.16 ME Systems
201.17 Electromagnetic compatibility of me equipment and me systems
35 202 Electromagnetic disturbances – Requirements and tests
203 Radiation protection in diagnostic x-ray equipment
48 Annexes
49 Annex AA (informative) Particular guidance and rationale
Table AA.1 – Examples of prolonged radioscopically guided interventional procedures for which deterministic effects of irradiation are possible
50 Table AA.2 – Examples of radioscopically guided interventional procedures for which deterministic effects are unlikely
59 Table AA.3 – Examples of isodose boundaries and colour codes for skin dose map and air kerma map
61 Annex BB (normative) Distribution maps of stray radiation
62 Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration
63 Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration
64 Bibliography
67 Index of defined terms

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BS EN 60601-2-43:2022
$198.66