Alternate radiation methods
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Alternate radiation methods

Optional Tests for Alternate radiation methods

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D-value method validation or dose audit ANSI/AAMI/ISO 11137-2:2006

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Method 2 dose audit ANSI/AAMI/ISO 11137-2:2006

A Method 2 Validation, from standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. Method 2 is different from VDmax and Method 1 in that the verification and sterilization dose are based on the microorganism population radiation resistance (you can not fail a Method 2 Validation).

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Method 2 radiation validation ANSI/AAMI/ISO 11137-2:2006

A Method 2 Validation, from standard 11137, Annex B, is an ANSI/AAMI/ISO document approved for use by the FDA. Method 2 is different from VDmax and Method 1 in that the verification and sterilization dose are based on the microorganism population radiation resistance (you can not fail a Method 2 Validation).

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