Numéro de référence
ISO/WD TS 25364
ISO/WD TS 25364
© ISO 2024
Projet de travail
ISO/WD 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
Edition 1
Supprimée
Résumé
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.
Informations générales
-
État actuel: SuppriméeStade: Projet annulé [20.98]
-
Edition: 1
-
Comité technique :ISO/TC 194
- RSS mises à jour
