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IEC 80601-2-59 : 2.0

IEC 80601-2-59 : 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

International Electrotechnical Committee

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Table of Contents

FOREWORD<br>INTRODUCTION<br>201.1 Scope, object and related standards<br>201.2 Normative references <br>201.3 Terms and definitions<br>201.4 General requirements<br>201.5 General requirements for testing ME EQUIPMENT <br>201.6 Classification of ME EQUIPMENT and ME SYSTEMS <br>201.7 ME EQUIPMENT identification, marking and documents<br>201.8 Protection against electrical HAZARDS from<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT<br>201.9 Protection against mechanical HAZARDS of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT and ME SYSTEMS <br>201.10 Protection against unwanted and excessive<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;radiation HAZARDS<br>201.11 Protection against excessive temperatures and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;other HAZARDS<br>201.12 Accuracy of controls and instruments and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;protection against hazardous outputs<br>201.13 HAZARDOUS SITUATIONS and fault conditions<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for ME EQUIPMENT<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS <br>201.17 Electromagnetic compatibility of ME EQUIPMENT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS<br>201.101 LABORATORY ACCURACY of a SCREENING<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;THERMOGRAPH<br>201.102 SCREENING THERMOGRAPH ALARM CONDITIONS<br>202 Electromagnetic disturbances - Requirements and tests<br>206 USABILITY <br>Annexes<br>Annex C (informative) - Guide to marking and labeling<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements for ME EQUIPMENT and ME SYSTEMS <br>Annex AA (informative) - Particular guidance and rationale <br>Annex BB (normative) - CALIBRATION SOURCE<br>Annex CC (informative) - Reference to the essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;principles <br>Bibliography <br>Index of defined terms used in this document

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62

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