AAMI - TIR37
Sterilization of health care products—Radiation— Guidance on sterilization of human tissue-based products
inactive
| Organization: | AAMI |
| Publication Date: | 15 October 2007 |
| Status: | inactive |
| Page Count: | 23 |
scope:
Inclusions
This technical information report (TIR) provides guidance for sampling and testing requirements to validate radiation sterilization for human tissue-based products.
NOTE-Although the scope of this document is limited to human tissue-based products, it provides guidance that might be applicable to non-human tissue products.
Exclusions
This TIR does not address validation requirements for eliminating and/or inactivating viruses and prions or sterilization of cell/tissue by-products. Guidance on viruses and prions can be found in ANSI/AAMI/ISO 22442-3:200x (in development). This TIR also does not address handling or safety issues for cell/tissue by-products.
Document History
January 1, 2013
Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products
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...
TIR37
October 15, 2007
Sterilization of health care products—Radiation— Guidance on sterilization of human tissue-based products
Inclusions
This technical information report (TIR) provides guidance for sampling and testing requirements to validate radiation sterilization for human tissue-based products.
NOTE—Although the...