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AAMI TIR39

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices

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Organization: AAMI
Publication Date: 1 January 2009
Status: active
Page Count: 21
scope:

General

This technical information report (TIR) provides guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate inoculation sites, and the methods for inoculation and recovery of inoculated microorganisms from these sites.

Exclusions

The recommendations in this TIR are addressed to manufacturers of medical devices for sterilization validation testing and are not intended as guidance for routine or field testing of device sterilization.

This TIR does not cover microbial challenges or inoculation processes used for validation of cleaning or disinfection of medical devices.

Document History

January 1, 2009
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
General This technical information report (TIR) provides guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate...
AAMI TIR39
January 1, 2009
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
General This technical information report (TIR) provides guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate...
January 1, 2009
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
General This technical information report (TIR) provides guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate...

References

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