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AAMI TIR28:2009/(R)2013 PDF

AAMI TIR28:2009/(R)2013 PDF

Name:
AAMI TIR28:2009/(R)2013 PDF

Published Date:
03/17/2009

Status:
Active

Description:

Product adoption and process equivalency for ethylene oxide sterilization

Publisher:
Association for the Advancement of Medical Instrumentation

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
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Choose Document Language:
$39.3
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This AAMI technical information report (TIR) provides guidance for the adoption of a new or modified product into an existing validated sterilization process and for the determination of equivalency of a sterilization process as conducted in different equipment. Its guidance is intended to augment ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routine control of ethylene oxide sterilization, and to expand on the areas of product adoption and process equivalency that are not addressed in ANSI/AAMI/ISO 11135:1994.
File Size : 1 file , 130 KB
Note : This product is unavailable in Belarus, Russia, Ukraine
Number of Pages : 24
Part of : AAMI STBK10-3
Published : 03/17/2009

History

AAMI TIR28:2016/(R)2024
AAMI TIR28:2016/(R)2024
Published Date: 11/18/2016
Product adoption and process equivalency for ethylene oxide sterilization
$44.4
AAMI TIR28:2009/(R)2013
AAMI TIR28:2009/(R)2013
Published Date: 03/17/2009
Product adoption and process equivalency for ethylene oxide sterilization
$39.3
AAMI TIR28:2001
AAMI TIR28:2001
Published Date: 12/24/2001
Product adoption and process equivalency for ethylene oxide sterilization
$26.4

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