Workshop

Sterilization by irradiation for medical devices: what have been the normative changes in the last decade?


March 20, 2019 -

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Ana L. Matos Da Costa

One of the most common methods of sterilization for medical devices is sterilization by irradiation. The EN ISO 11137 standard is a three-part standard that deals with this mode of sterilization. EN ISO 11137-1, which describes the requirements for the development, validation and and the routine control of a sterilization process for medical devices, now in version 2016, underwent a major change in 2013: the addition of an amendment that reviews the definition of a sterilization family. EN ISO 11137-3 which concerns the dosimetry aspects was revised in 2017 with a significant impact on dose audits.

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