Reference number
ISO/WD TS 25364
ISO/WD TS 25364
© ISO 2024
Proyecto de trabajo
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
Eliminada
Resumen
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.
Informaciones generales
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Estado: EliminadoEtapa: Proyecto eliminado [20.98]
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Edición: 1
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Comité Técnico :ISO/TC 194
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