-
-
Available Formats
- Options
- Availability
- Priced From ( in USD )
-
Available Formats
-
- Immediate download
- $57.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $66.00
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 10993-13:2010
Priced From $124.00 -
ISO 12772:1997
Priced From $81.00 -
ISO 10993-15:2019
Priced From $124.00 -
ISO 15194:2009
Priced From $124.00
About This Item
Full Description
This part of ISO 10993 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.
This part of ISO 10993 is not applicable to:
- viable-tissue engineered products;
- methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available;
- leachable components which are not degradation products.
Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.
Document History
-
ISO 10993-9:2019
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products- Most Recent
-
ISO 10993-9:2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products- Historical Version
-
ISO 10993-9:1999
viewing
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products- Historical Version