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About This Item
Full Description
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.
Document History
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AAMI/ISO 11135:2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices- Most Recent
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AAMI/ISO TIR11135-2:2008
Sterilization of health care products - Ethylene oxide--- Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1- Historical Version
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AAMI/ISO 11135-1 / 11135-2 SET
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Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (11135-1:2007) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008)- Historical Version
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AAMI/ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices- Historical Version
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AAMI 11135:1994
Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata- Historical Version