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 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 ME EQUIPMENT <br>201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS <br>201.10 Protection against unwanted and excessive radiation <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS <br>201.11 Protection against excessive temperatures and other <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS <br>201.12 Accuracy of controls and instruments and protection <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;against hazardous outputs <br>201.13 HAZARDOUS SITUATIONS and fault conditions<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS<br>201.17 Electromagnetic compatibility of ME EQUIPMENT and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME SYSTEMS <br>202 Electromagnetic compatibility - Requirements and tests<br>Annexes<br>Annex AA (informative) - Particular guidance and rationale<br>Annex BB (informative) - ELECTRODES, their positions, <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;identifications and colour codes<br>Annex CC (informative) - LEADS, their identification and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;colour codes (other than those specified in <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;201.12.4.102)<br>Annex DD (informative) - Polarity of PATIENT LEADS <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(other than those specified in 201.12.4.102)<br>Annex EE (informative) - Additional marking of ELECTRODES<br>Annex FF (informative) - Definitions and rules for the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;measurement of ELECTROCARDIOGRAMS<br>Annex GG (informative) - Calibration and test data sets<br>Annex HH (informative) - CTS test atlas<br>Bibliography<br>Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Electrotechnical Committee
Pages
ISBN
Committee	TC 62