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BS EN IEC 80601-2-26:2020:2021 Edition

BS EN IEC 80601-2-26:2020:2021 Edition

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

Published By Publication Date Number of Pages
BSI 2021 42
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IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
8 FOREWORD
11 INTRODUCTION
12 201.1 Scope, object and related standards
14 201.2 Normative references
201.3 Terms and definitions
15 201.4 General requirements
16 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
Tables
Table 201.101 – Distributed essential performance requirements
17 201.7 Me equipment identification, marking and documents
18 201.8 Protection against electrical hazards from me equipment
20 Figures
Figure 201.101 – Test of protection against the effectsof defibrillation (common mode)
22 Figure 201.102 – Test of protection against the effectsof defibrillation (differential mode)
23 201.9 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
24 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
25 201.12 Accuracy of controls and instruments and protection against hazardous outputs
Table 201.102 – Input voltage ranges and rates of variation
26 Figure 201.104 – General test circuit
28 Figure 201.105 – Test circuit for noise and common mode rejection(see 201.12.1.104 and 201.12.1.106)
29 201.13 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
30 Figure 202.101 – Test layout for radiated and conducted emission testand radiated immunity test(see 202.4.3.1)
32 Figure 202.102 –Test circuit for hf surgical equipment protection measurementaccording to 202.8.101
33 206 Usability
Figure 202.103 – Test setup for hf surgical equipment measurementaccording to 202.8.101
34 Annexes
35 Annex AA (informative)Particular guidance and rationale
38 Bibliography
39 Index of defined terms used in this particular standard

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