Table of Contents

FOREWORD<br>INTRODUCTION<br>INTRODUCTION to the Amendment<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 ME <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS<br>202 Electromagnetic disturbances - Requirements and tests<br>203 Radiation protection in diagnostic X-ray equipment<br>Annexes<br>Annex AA (informative) - Particular guidance and rationale<br>Annex BB (normative) - Distribution maps of STRAY RADIATION<br>Annex CC (informative) - Mapping between this Edition 2 of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;IEC 60601-2-43 and Edition 1<br>Bibliography<br>Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.

General Product Information

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