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