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  3. AAMI/ISO 10993-9:2009/(R)2014 PDF

AAMI/ISO 10993-9:2009/(R)2014 PDF

AAMI/ISO 10993-9:2009/(R)2014 PDF

Name:
AAMI/ISO 10993-9:2009/(R)2014 PDF

Published Date:
08/17/2010

Status:
Active

Description:

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

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
SKU:
Choose Document Language:
$44.7
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ANSI/AAMI/ISO 10993-9 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. Considers both non-resorbable and resorbable materials. Not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.
ANSI : ANSI Approved
File Size : 1 file , 300 KB
ISBN(s) : 1570203849
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 22
Published : 08/17/2010
Same As : AAMI/ISO 10993-9:2009/(R)2014

History

AAMI/ISO 10993-9:2009/(R)2014
AAMI/ISO 10993-9:2009/(R)2014
Published Date: 08/17/2010
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
$44.7
AAMI/ISO 10993-9:1999/(R2005)
AAMI/ISO 10993-9:1999/(R2005)
Published Date: 06/27/2000
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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