Standard

ISO 11135:1994

Withdrawn

Note: This standard has a draft: ISO/DIS 11135

Corrigendums and amendments are bought separately.

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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.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • ICS 11.080.01
  • ISO TC ISO/TC 198

Product Relations

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