EN ISO 10993-9:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) - Consideration of the need for
                      degradation studies
Annex B (informative) - Biodegradation study considerations
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC on Medical
                         devices
Annex ZB (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 90/385/EEC on Active
                         Implantable Medical Devices
Bibliography

ISO 10993-9:2008 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. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.