Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)
This Malaysian Standard 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 MS ISO 10993 series. This standard considers both non-resorbable and resorbable materials.
This standard is 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.
Published
• (none) / (none) / (none)
PDF
17/01/2021
19
NSC 18 - Medical Devices and Facilities for Healthcare
