AAMI TIR14:2009 PDF

AAMI TIR14:2009 PDF

Name:
AAMI TIR14:2009 PDF

Published Date:
03/17/2009

Status:
Active

Description:

Contract sterilization using ethylene oxide

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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$36.9
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This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.

EO contract sterilization guidance for health care providers is not specifically covered in this TIR.

Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
File Size : 1 file , 350 KB
ISBN(s) : 1570203377
Note : This product is unavailable in Belarus, Russia, Ukraine
Number of Pages : 22
Part of : AAMI STBK10-3
Published : 03/17/2009

History

AAMI TIR14:2009
Published Date: 03/17/2009
Contract sterilization using ethylene oxide
$36.9
AAMI TIR14:1997/A1:2004
Published Date: 07/15/2004
Contract Sterilization for Ethylene Oxide, Includes Amendment 1
$29.7
AAMI TIR14:1997
Published Date: 02/24/1997
Guidance for the Validation and Routine Control of Industrial Ethylene Oxide Sterilization - Contract Sterilization
$29.7

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