Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
Abstract
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.
DIN EN ISO 10993-9:2010-04 (E)
Biological evaluation of medical devices – Part 9: Framework for identification and
quantification of potential d egradation products (ISO 10993-9:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Principles for design of degradation studies ……………………………………………………………………6
4.1 General …………………………………………………………………………………………………………………………..6
4.2 Preliminary considerations ……………………………………………………………………………………………..7
4.3 Study design …………………………………………………………………………………………………………………..7
4.4 Characterization of degradation products from medical devices ………………………………………8
5 Study report ……………………………………………………………………………………………………………………8
Annex A (normative) Consideration of the need for degradation studies …………………………………………9
Annex B (informative) Biodegradation study considerations …………………………………………………………11
Bibliography …………………………………………………………………………………………………………………………………13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices …………………………………………14
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………….15