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ONORM EN ISO 10993-7:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019) (consolidated version)

This part of ISO 10993 specifies the permissible limit values for the residual content of ethylene oxide (EO) and ethylene chlorine hydrine (residual-ech) in individual medical devices sterilized with EO, the procedures for measuring EO and ECH as well as the methods for determining the agreement, so that the products can be released. Further background information, instructions and a flow diagram on which this document is used are also included in the informative attachments. EO-stilized products that do not come into contact with patients (e.g. in-vitro diagnostics) do not fall within the scope of this part of ISO 10993.

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