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DIN EN ISO 11137-2/A1:2021 Edition

DIN EN ISO 11137-2/A1:2021 Edition

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Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – AMENDMENT 1

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DIN 2021-02 31
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This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. This part of ISO 11137 also specifies methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

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DIN EN ISO 11137-2/A1
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