Table of Contents

FOREWORD<br>INTRODUCTION<br>201.1 Scope, object and related standards <br>201.2 Normative references<br>201.3 Terminology 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 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;&nbsp;EQUIPMENT 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 ME <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS <br>202.6 ELECTROMAGNETIC COMPATIBILITY <br>Annex AA (informative) - Guidance and rationale for particular <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;subclauses <br>Annex BB (informative) - Guidance in classification according <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;to CISPR 11<br>Annex CC (informative) - Guidance to the MANUFACTURER on the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;interpretation of TI and MI to be used to inform the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;OPERATOR<br>Annex DD (informative) - Example set-up to measure surface <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;temperature of externally applied TRANSDUCER ASSEMBLIES<br>Bibliography<br>Index of defined terms

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT, hereinafter referred to as ME EQUIPMENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
ProductNote	Reconfirmed EN
Pages
ISBN