DSF/prEN ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2007)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 19 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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. Information obtained from these studies is to be used in the biological evaluations described in the remaining parts of ISO 10993.
Where product standards provide applicable product-specific methodologies for the identification and
quantification of degradation products, those standards shall be considered as alternatives.
This part of ISO 10993 is not applicable to:
a) methodologies for the generation of degradation products 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.
NOTE One may apply this standard to the degradation of materials used in other therapeutic products e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics. Other standards and guidance may apply to those finished products.
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