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  3. AAMI/ISO 10993-7:2008/(R)2012 PDF

AAMI/ISO 10993-7:2008/(R)2012 PDF

AAMI/ISO 10993-7:2008/(R)2012 PDF

Name:
AAMI/ISO 10993-7:2008/(R)2012 PDF

Published Date:
12/10/2007

Status:
Active

Description:

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

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:
$81.9
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Includes a January 2010 erratum at the end.

AAMI/ISO 10993-7 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

Additional background, including guidance and a flowchart showing how this document is applied, is also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.
ANSI : ANSI Approved
File Size : 1 file , 1.7 MB
ISBN(s) : 1570203326
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 112
Part of : AAMI STBK10-3
Published : 12/10/2007

History

AAMI/ISO 10993-7:2008/(R)2012
AAMI/ISO 10993-7:2008/(R)2012
Published Date: 12/10/2007
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)
$81.9
AAMI/ISO 10993-7
AAMI/ISO 10993-7
Published Date: 09/01/1995
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals - SAME AS ISO 10993-7
$33

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