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ANSI/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
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Summary
This standard describes requirements that, if met, will provide an ethylene oxide sterilization process intended to sterilize medical devices that has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that validations conducted following this International Standard will provide products that meet the defined requirements for sterile products with a high degree of confidence. Annex 2
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2014 |
| Page Count | 0 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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