EN ISO 10993-16:2017 pdf download.Biological evaluation of medical devices — Toxicokinetic study design for degradation products and leachables
1 Scope
2 Normative references
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
3 Terms and definitions
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1 absorption
3.2 bioavailability
3.3 biodegradation
3.4 bioresorption
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
Medical devices — Application of risk management to medical devices
EN ISO 10993-16:2017 pdf download
