Table of Contents

FOREWORD<br>INTRODUCTION<br>1 Scope, object and related standards<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 General requirements for testing ME EQUIPMENT<br>6 Classification of ME EQUIPMENT and ME SYSTEMS<br>7 ME EQUIPMENT identification, marking and documents<br>8 Protection against excessive temperatures and other HAZARDS<br>9 Accuracy of controls and instruments and protection against<br>&nbsp;&nbsp;&nbsp;hazardous outputs<br>10 Construction of ME EQUIPMENT<br>11 Protection against strangulation or asphyxiation<br>12 Additional requirements for ELECTROMAGNETIC EMISSIONS<br>&nbsp;&nbsp;&nbsp;of ME EQUIPMENT and ME SYSTEMS<br>13 Additional requirements for ALARM SYSTEMS of ME<br>&nbsp;&nbsp;&nbsp;EQUIPMENT and ME SYSTEMS<br>Annex A (informative) - General guidance and rationale<br>Annex B (informative) - Guide to marking and labelling<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements for ME EQUIPMENT and ME SYSTEMS<br>Annex C (informative) - Symbols on marking<br>Bibliography<br>Index of defined terms used in this collateral standard<br>Annex ZA (normative) - Normative references to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;international publications with their<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;corresponding European publications<br>Annex ZZ (informative) - Coverage of Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directives

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/62/1
Supersedes	14/30296572 DC : 0 09/30155521 DC : 0