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AAMI - TIR28

Product adoption and process equivalence for ethylene oxide sterilization

active, Most Current
Organization: AAMI
Publication Date: 1 January 2016
Status: active
Page Count: 22
scope:

This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the sterilization of medical devices:

a) a new product is being added to the previously validated process,

b) changes to validated products are being evaluated,

c) a previously validated process is being moved to a different facility or to different equipment, and

d) equivalency of a sterilization process is being evaluated.

Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.

Document History

TIR28
January 1, 2016
Product adoption and process equivalence for ethylene oxide sterilization
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the...
January 1, 2009
Product adoption and process equivalence for ethylene oxide sterilization
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the...
January 1, 2009
Product adoption and process equivalence for ethylene oxide sterilization
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the...
January 1, 2001
PRODUCT ADOPTION AND PROCESS EQUIVALENCY FOR ETHYLENE OXIDE STERILIZATION
A description is not available for this item.

References

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