AS ISO 10993.17-2004廢止
Biological evaluation of medical devices Establishment of allowable limits for leachable substances
出版：Standards Australia
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基本信息
標準編號： AS ISO 10993.17-2004
發布時間：2004/9/15 0:00:00
標準類別：Standard
出版單位：Standards Australia
標準頁數：25
標準簡介
Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in?vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO?10993-17:2002.
本標準替代的舊標準
等同采用的國際標準
ISO 10993-17:2002 - Identical
