Standard

AAMI TIR16:2000

Withdrawn

Note: This standard has a new edition: AAMI TIR16:2023

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Abstract

This AAMI technical information report presents the various microbiological aspects of the development of an ethylene oxide sterilization process and the validation of this process. This document does not discuss the effect of the microbiological bioburden or the effect of the environment that the product is exposed to during the manufacturing process. TIR16:2000 is a companion document to ANSI/AAMI/ISO 11135:1994.

Document information

  • Standard from AAMI
  • Published:
  • Version: 0
  • Document type: IS
  • Pages

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