Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
Abstract
ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
DIN EN ISO 10993-16:2010-06 (E)
Biological evaluation of medical devices – Part 16: Toxicokinetic stud y design for
degradation products and leachables (ISO 10993-16:2010)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
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 ………….17
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Principles for design of toxicokinetic studies ………………………………………………………………….7
5 Guidance on test methods ………………………………………………………………………………………………8
5.1 General considerations …………………………………………………………………………………………………..8
5.2 Guidance on specific types of test …………………………………………………………………………………..9
5.2.1 General …………………………………………………………………………………………………………………………..9
5.2.2 Absorption ……………………………………………………………………………………………………………………..9
5.2.3 Distribution …………………………………………………………………………………………………………………..10
5.2.4 Metabolism and excretion ……………………………………………………………………………………………..10
Annex A (normative) Circumstances in which toxicokinetic studies shall be considered ……………….11
Bibliography …………………………………………………………………………………………………………………………………12