Reference number
ISO 11135:1994
© ISO 2024
ISO 11135:1994
Medical devices — Validation and routine control of ethylene oxide sterilization
Edition 1
1994-01
Withdrawn
Withdrawn (Edition 1, 1994)

Abstract

Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.

General information

  • Status
     : Withdrawn
    Publication date
     : 1994-01
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 24
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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