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 <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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS (PEMS) <br>201.15 Construction of ME EQUIPMENT <br>201.16 ME SYSTEMS <br>201.17 Electromagnetic compatibility of ME EQUIPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS <br>202 Electromagnetic compatibility - Requirements and tests<br>208 General requirements, tests and guidance for alarm <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;systems in medical electrical equipment and medical <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;electrical systems <br>210 Process requirements for the development of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;PHYSIOLOGIC CLOSED-LOOP CONTROLLERS <br>211 Requirements for MEDICAL ELECTRICAL EQUIPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and MEDICAL ELECTRICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT <br>Annexes <br>Annex G (normative) - Protection against HAZARDS of ignition <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of flammable anaesthetic mixtures <br>Annex AA (informative) - Particular guidance and rationale <br>Annex BB (informative) - Examples of HAZARDS, foreseeable <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;sequences of events, and HAZARDOUS SITUATIONS <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in HAEMODIALYSIS EQUIPMENT <br>Bibliography <br>Annex ZA (normative) - Normative references to international <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European publications<br>Annex ZZ (informative) - Coverage of Essential Requirements <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EU Directives<br>Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/150/2
Supersedes	10/30239741 DC : 0 BS 5724-2.16(1998) : 1998 BS 5724-2.16(1989) : 1989 96/560319 DC : FEB 96