1. Scope
2. Normative references
3. Terms and definitions
4. Principles for design of degradation studies
4.1 General
4.2 Preliminary considerations
4.3 Study design
4.4 Characterization of degradation products
from medical devices
5. Study report
Annex A (normative) Consideration of the need for
degradation studies
Annex B (informative) Biodegradation study considerations
Bibliography