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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. Product Details
Published: 01/01/2004File Size: 1 file , 810 KB