Table of Contents

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
       from 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
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
202 Electromagnetic compatibility - Requirements
       and tests
Annexes
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - ELECTRODES, their positions,
         identifications and colour codes
Annex CC (informative) - LEADS, their identification
         and colour codes (other than those specified in
         201.12.4.102)
Annex DD (informative) - Polarity of PATIENT LEADS
         (other than those specified in 201.12.4.102)
Annex EE (informative) - Additional marking of
         ELECTRODES
Annex FF (informative) - Definitions and rules for the
         measurement of ELECTROCARDIOGRAMS
Annex GG (informative) - Calibration and test data sets
Annex HH (informative) - CTS test atlas
Bibliography
Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS 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	Canadian Standards Association
Pages
ISBN
Supersedes	CSA C22.2.601.2.25 : 1994 CSA C22.2.60601.2.51 : 2004