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ISO 10993-9:2019现行

Biological evaluation of medical devices — Part9: Framework for identification and quantification of potential degradation products

出版:International Organization for Standardization

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基本信息
标准编号: ISO 10993-9:2019
标准类别:Standard
出版单位:International Organization for Standardization
标准页数:0
标准简介

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies.

本标准替代的旧标准

ISO 10993-9 : 2009(R2013)