REGISTER OVERVIEW PLASTICS

13/68 PLASTICS
LIFE SCIENCE GRADES (LSG)
Biocompatibility status
(USP and ISO 10993)
Quadrant LSG semi-finished product forms have been subjected to
a comprehensive range of biocompatibility tests by an independent,
internationally renowned and approved testing organisation,
in order to check that these materials meet the requirements of
the USP (United States Pharmacopeia) guideline and of standard
ISO 10993-1 in relation to biocompatibility tests
of materials.
Quadrant Engineering Plastic Products gives no warranty
or guarantee that the materials have been manufactured in
accordance with the applicable and required quality standards
for materials intended for use in implantable medical devices or
in applications that are of crucial importance when it comes to
restoring or maintaining a bodily function that is essential for
maintaining human life.
Life science grades by Quadrant may not be used in conjunction
with medical devices that are intended for use as implants that will
remain in the human body for longer than 24 hours (30 days*) or
that are intended to remain in contact with internal human tissue
or with bodily fluids for longer than 24 hours (30 days*). Nor may
these materials be used to produce important components of
medical devices that are essential for maintaining human life.
*: "30 days" only applies to Ketron ® CLASSIX TM LSG PEEK white.
plastics@reiff-group.com / www.reiff-tp.com