AAMI TIR20:2001

AAMI TIR20:2001

Click here to purchase
This AAMI technical information report (TIR) provides guidance to augment information andrequirements for parametric release provided in ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intended to assistthose individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary todevelop and validate an ethylene oxide sterilization process that meets the standard?srequirements for parametric release. This TIR also provides guidance for choosing theappropriate actions where alternatives are given. The guidance in this TIR is limited to thesections of the standard that specifically address parametric release.

Product Details

Published:
09/24/2001
Number of Pages:
32
File Size:
1 file , 230 KB

You may also like

AAMI SW96:2023

AAMI SW96:2023

Standard for medical device security—Security risk management for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 12/21/2022

AAMI TIR45:2023

AAMI TIR45:2023

Guidance on the use of agile practices in the development of medical device softwarestandard by Association for the Advancement of...

AAMI ST108:2023

AAMI ST108:2023

Water for the processing of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/17/2023

AAMI TIR34971:2023

AAMI TIR34971:2023

Application of ISO 14971 to machine learning in artificial intelligence—Guidestandard by Association for the Advancement of Medical Instrumentation, 03/14/2023

Back to Top