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IEC 60601-2-23 : 3.0

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IEC 60601-2-23 : 3.0

MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT

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 of ME <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT <br>201.6 Classification of ME EQUIPMENT and ME 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 ME <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS of ME <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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>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>202 Electromagnetic compatibility - Requirements <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and tests<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>Annex BB (informative) - Alarm diagrams of Clause <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;208/IEC 60601-1-8:2006 <br>Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system.

General Product Information

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