Table of Contents

FOREWORD <br>1 Scope and object <br>2 Normative references<br>3 Terms and definitions <br>4 Tests <br>5 Marking and documentation <br>6 Protection against electric shock <br>7 Protection against mechanical HAZARDS <br>8 Resistance to mechanical stresses <br>9 Protection against the spread of fire <br>10 Equipment temperature limits and resistance to heat <br>11 Protection against HAZARDS from fluids <br>12 Protection against radiation, including laser sources, <br>&nbsp;&nbsp;&nbsp;and against sonic and ultrasonic pressure <br>13 Protection against liberated gases and substances, <br>&nbsp;&nbsp;explosion and implosion <br>14 Components and subassemblies <br>15 Protection by interlocks <br>16 HAZARDS resulting from application<br>17 RISK assessment <br>Annexes <br>Annex L (informative) - Index of defined terms <br>Bibliography <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) - Relationship between this <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the essential <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements of Directive 98/79/EC <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[OJ L 331] aimed to be covered

Abstract

Pertains to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	EPL/66
Supersedes	12/30269739 DC : 0 99/403334 DC : DRAFT JUN 1999