Sterilization
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RAJ
01/09/2015 06:50
Dear all,
Can a medical device instrument be EO sterilized 3 - 4 times continuously and be sold. By doing so will the device incur more EO residue or it will affect the sterility of the product or it will affect the packaging integrity.
Appreciate all your responses.
Regards,
-Raj.
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Medical Devices Committee
05/10/2015 11:28
The device and packaging can be sterilised by EO multiple times so long as there is adequate validation data to determine the effect on the integrity of the device, as well as EO and EO breakdown product residues. Probably worth a discussion with your Notified Body. See ISO 11135:2014 - Sterilization of healthcare products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices; and AAMI TIR28: 2009/R2013 Product adoption and process equivalence for ethylene oxide sterilisation.
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