Silicone Medical FDA

The latest FDA endorsed level of testing was published in May 1995 and is often called the "Blue Book Memorandum" and is based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices". The Blue Book Memorandum covers a variety of biomaterials from IV tubing sets to dental cements to long term implantable devices made of metals, ceramics, plastics and elastomers.

Silicone Medical FDA

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