Table of Contents

FOREWORD
1 Scope and object
2 Normative references
3 Terms and definitions
4 Tests
5 Marking and documentation
6 Protection against electric shock
7 Protection against mechanical HAZARDS
8 Resistance to mechanical stresses
9 Protection against the spread of fire
10 Equipment temperature limits and resistance
   to heat
11 Protection against HAZARDS from fluids
12 Protection against radiation, including laser sources,
   and against sonic and ultrasonic pressure
13 Protection against liberated gases and substances, explosion
   and implosion
14 Components and subassemblies
15 Protection by interlocks
16 HAZARDS resulting from application
17 RISK assessment
Annexes
Annex L (informative) - Index of defined terms
Bibliography

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	International Electrotechnical Committee
Pages
ISBN
Committee	TC 66