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ONORM EN ISO 10993-17:2003被替代

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

出版:Osterreichisches Normungsinstitut

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基本信息
標(biāo)準(zhǔn)編號: ONORM EN ISO 10993-17:2003
發(fā)布時間:2003/6/1 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Osterreichisches Normungsinstitut
標(biāo)準(zhǔn)頁數(shù):31
標(biāo)準(zhǔn)簡介

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

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

ONORM EN ISO 10993-17:2009