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AAMI TIR29:2012/(R)2017 [HISTORICAL]

Guide for process characterization and control in radiation sterilization of medical devices
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AAMI TIR29:2012/(R)2017 [HISTORICAL]

Guide for process characterization and control in radiation sterilization of medical devices

PUBLISH DATE 2012
AAMI TIR29:2012/(R)2017 [HISTORICAL]
This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization. This document has been superseded by AAMI/ISO TIR11137-4:2022; Sterilization of health care products—Radiation—Part 4: guidance on process control. This document is no longer being maintained by and should not be used for new designs.  Every 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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR29
Publication Date Jan. 1, 2012
Language en - English
Page Count 56
Revision Level
Supercedes
Committee
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