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IEC 80601-2-49 : 2018

IEC 80601-2-49 : 2018

MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORS

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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT <br>201.6 Classification of ME EQUIPMENT and ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS <br>201.7 ME EQUIPMENT identification, marking and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and 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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS (PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS <br>201.17 Electromagnetic compatibility of ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT and ME SYSTEMS<br>202 Electromagnetic disturbances - Requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and tests<br>206 USABILITY <br>208 General requirements, tests and guidance for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and MEDICAL ELECTRICAL SYSTEMS<br>Annexes<br>Annex AA (informative) - Particular guidance and rationale <br>Bibliography <br>Index of defined terms used in this particular standard

Abstract

Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS.

General Product Information

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

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