Abstract 

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.


General information

  • Status :  Withdrawn
    Publication date : 1995-10
  • Edition : 1
    Number of pages : 40
  • Technical Committee
    :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • ICS :
    11.100.20
    Biological evaluation of medical devices

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

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