Foreword
Introduction
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
B.1 General
B.2 Description of medical device and/or
material
B.3 Assessment of potential and known degradation
products
B.3.1 Bulk material changes
B.3.2 Release of substances from the surface
B.3.3 Multicomponent device or device used
with other components
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices and
90/385/EEC on Active Implantable Medical Devices
Bibliography