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UNI EN ISO 10993-18:2023

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor

Published date

09-28-2023

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents.

Committee
CT 44
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

Standards Relationship
EN ISO 10993-18:2020 Identical
ISO 10993-18:2020/Amd 1:2022 Identical
ISO 10993-18:2020 Identical
EN ISO 10993-18:2020/A1:2023 Identical

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