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UNI EN ISO 10993-17:2009现行

Biological Evaluation Of Medical Devices - Part 17: Establishment Of Allowable Limits For Leachable Substances

出版：Italian Standards

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基本信息

标准编号： UNI EN ISO 10993-17:2009

标准类别：Standard

出版单位：Italian Standards

标准页数：0

标准简介

Describes a method for the determination of allowable limits for substances leachable from medical devices. Determines use in deriving standards and estimating appropriate limits where standards do not exist. Also specifies a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

本标准替代的旧标准

UNI EN ISO 10993-17:2004

等同采用的国际标准

SN EN ISO 10993-17:2003 - Identical

BS EN ISO 10993-17:2009 - Identical

NEN EN ISO 10993-17:2009 - Identical

NS EN ISO 10993-17:2009 - Identical

SS EN ISO 10993-17 Ed. 2 (2009) - Identical

I.S. EN ISO 10993-17:2009 - Identical

NF EN ISO 10993-17:2009 - Identical

DIN EN ISO 10993-17 (2009-08) - Identical

UNE EN ISO 10993-17:2009 - Identical