I.S. EN IEC 80601-2-26:2020/A1:2024
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
Hardcopy , PDF
English
27-03-2024
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FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
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
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
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
201.12 Accuracy of controls and instruments and protection against hazardous outputs
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
206 USABILITY
Annex AA (informative) Particular guidance and rationale
Bibliography
This part of the 80601 International Standard 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.
| DocumentType |
Standard
|
| ISBN |
978-2-8322-6765-3
|
| Pages |
44
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN IEC 80601-2-26:2020/AC:2021-10 | Identical |
| IEC 80601-2-26:2019/COR1:2021 | Identical |
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