Reference number
ISO/WD TS 25364
© ISO 2024
Working draft
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
Deleted
Deleted
A working group has prepared a draft.

Abstract

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.

General information

  • Status
     : Deleted
    Stage
    : Project deleted [20.98]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 194
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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