About AAMI/ISO 11135-1:2007
Specifies requirements for the development, validation, and routine control of an ethylene oxide
sterilization process for medical devices.
About AAMI/ISO TIR11135-2:2008
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not
repeat the requirements and is not intended to be used in isolation.
The exclusions in ISO 11135-1 apply also to this Technical Specification.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in
ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in
Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification..
This guidance document is intended for people who have a basic knowledge of the principles of EO
sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-
1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
| ANSI : | ANSI Approved |
| Number of Pages : | 122 |
| Published : | 09/23/2008 |
