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UNI EN ISO 10993-13:2010现行

Biological Evaluation Of Medical Devices - Part 13: Identification And Quantification Of Degradation Products From Polymeric Medical Devices

出版：Italian Standards

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基本信息

标准编号： UNI EN ISO 10993-13:2010

标准类别：Standard

出版单位：Italian Standards

标准页数：0

标准简介

Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. Also provides two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment.

本标准替代的旧标准

UNI EN ISO 10993-13:2009

等同采用的国际标准

NF EN ISO 10993-13:2009 - Identical

SS EN ISO 10993-13 Ed. 2 (2009) - Identical

ONORM EN ISO 10993-13:2009 - Identical

I.S. EN ISO 10993-13:2010 - Identical

BS EN ISO 10993-13:2010 - Identical

NF EN ISO 10993-13:2010 - Identical

NBN EN ISO 10993-13:2010 - Identical

NEN EN ISO 10993-13:2010 - Identical

SS EN ISO 10993-13 Ed. 3 (2010) - Identical