This AAMI technical information report (TIR) provides guidance to augment information and
requirements 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 assist
those individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary to
develop and validate an ethylene oxide sterilization process that meets the standard?s
requirements for parametric release. This TIR also provides guidance for choosing the
appropriate actions where alternatives are given. The guidance in this TIR is limited to the
sections of the standard that specifically address parametric release.
| File Size : | 1
file
, 230 KB |
| Note : | This product is unavailable in Belarus, Russia, Ukraine |
| Number of Pages : | 32 |
| Published : | 09/24/2001 |
