Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products Ingestion-build-180956 Mechanical testing of implantable spinal

Mechanical testing of implantable spinal devices

surface qualities and surface condition requirements

There are some editorial amendments

The relevant test methods are given in EN 60811 series and EN 50396

Note: A thermal class is not assigned to an EIM as related to its use in an EIS

Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products Ingestion-build-180956 Mechanical testing of implantable spinal1 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: