ISO/NP TS 25364

Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18

Scope

This document was written to augment ISO 10993-18:2020. Specifically, this document addresses and provides best practice recommendations for:
— Uncertainty in Leachables and Extractables Measurements;
— Derivation, Calculation and Application of the Analytical Evaluation Threshold (AET);
— Best Practices for Leachables and Extractables Identification;
— Best Practices for Leachables and Extractables Quantification;
— Requirements for Instrumentation and Human Resources.