Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables Ingestion-build-205840 21 Loss of mass 6

21 Loss of mass 6

testing on individual paint components

The guidance given on inerting is also applicable to prevent an explosion in case of a fire

BS EN 16090 on estimating average grain size by ultrasound is relevant to:

CAUTION Persons using this Technical Specification should be familiar with the procedures for gas chromatography – mass spectrometry measurement and analysis

Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables Ingestion-build-205840 21 Loss of mass 61 Scope This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.