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BS EN IEC 80601-2-26:2020+A1:2024

BS EN IEC 80601-2-26:2020+A1:2024

$167.15

Medical electrical equipment – Particular requirements for the basic safety and essential performance of electroencephalographs

Published By Publication Date Number of Pages
BSI 2024 44
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PDF Catalog

PDF Pages PDF Title
2 undefined
5 Blank Page
6 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
8 Blank Page
9 English
CONTENTS
10 FOREWORD
13 INTRODUCTION
14 201.1 Scope, object and related standards
16 201.2 Normative references
201.3 Terms and definitions
17 201.4 General requirements
18 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
Tables
Table 201.101 – Distributed essential performance requirements
19 201.7 Me equipment identification, marking and documents
20 201.8 Protection against electrical hazards from me equipment
22 Figures
Figure 201.101 – Test of protection against the effectsof defibrillation (common mode)
24 Figure 201.102 – Test of protection against the effectsof defibrillation (differential mode)
25 201.9 Protection against mechanical hazards of me equipment and me systems
Figure 201.103 – Application of the test voltage between lead wiresto test the energy delivered by the defibrillator
26 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
27 201.12 Accuracy of controls and instruments and protection against hazardous outputs
Table 201.102 – Input voltage ranges and rates of variation
28 Figure 201.104 – General test circuit
30 Figure 201.105 – Test circuit for noise and common mode rejection(see 201.12.1.104 and 201.12.1.106)
31 201.13 Hazardous situations and fault conditions for me equipment
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 disturbances – Requirements and tests
32 Figure 202.101 – Test layout for radiated and conducted emission testand radiated immunity test(see 202.4.3.1)
34 Figure 202.102 –Test circuit for hf surgical equipment protection measurementaccording to 202.8.101
35 206 Usability
Figure 202.103 – Test setup for hf surgical equipment measurementaccording to 202.8.101
36 Annexes
37 Annex AA (informative)Particular guidance and rationale
40 Bibliography
41 Index of defined terms used in this particular standard

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BS EN IEC 80601-2-26:2020+A1:2024
$167.15