AAMI TIR37:2013 [HISTORICAL]

This AAMI Technical Information Report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products. This document has been superseded by  AAMI/ISO TIR22456:2022; Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products. This document is no longer being maintained by AAMI and should not be used for new designs.  Every AAMI standard is subjected to review at least every five (5) years. When a standard is more than five years old, has not undergone revision or review, and/or no longer carries the ANSI designation, it is reasonable to conclude that the contents, while still of some historic value, do not reflect the present state of the art. All copyrights remain in full effect. No annex