Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products Ingestion-build-81500 BS EN 12452 on rolled

BS EN 12452 on rolled

thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document

except in the following circumstances:

especially for outdoor applications

BS EN 60068-2-6 on environmental testing for sinusoidal vibration applies to:

Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products Ingestion-build-81500 BS EN 12452 on rolled1 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 can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non resorbable and resorbable materials. This part of ISO 10993 is not applicable to: