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

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

Best Price Guarantee Jan 1, 2012 English 56 Pages

Sub Total (1 Item(s)) $ 0.00
Estimated Shipping $ 0.00
Total (Pre-Tax) $ 0.00

You own the digital copy of this edition

View in Library
or
Assoc. for the Advancement of Medical Instrumentation Logo

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 This document has been superseded by AAMI/ISO TIR11137-4:2022; Sterilization of health care products—Radiation—Part 4: guidance on process control.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.
Loading...

Failed to load document history.

Publish Date Document Id Type View