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16/30349981 DC : 0

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NA

Status of Standard is Unknown

BS EN 80601-2-59 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING

Available format(s)

Hardcopy , PDF

Language(s)

English

€23.37
Excluding VAT

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 of 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 form 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
201.101 LABORATORY ACCURACY of a SCREENING
        THERMOGRAPH
201.102 SCREENING THERMOGRAPH ALARM CONDITIONS
202 Electromagnetic disturbances - Requirements
    and tests
206 USABILITY
Annexes
Annex C (informative) - Guide to marking and labelling
         requirements for ME EQUIPMENT And ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - CALIBRATION SOURCE
Annex CC (informative) - Reference to the essential principles
Bibliography
Alphabetized index of defined terms used in this particular
standard

BS EN 80601-2-59 Ed 2.0.

Committee
CH/62
DocumentType
Draft
Pages
42
PublisherName
British Standards Institution
Status
NA

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ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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