BORMED HE9621-PH

Description

Bormed™ HE9621-PH is a high density polyethylene intended for evaluation for use in Healthcare applications. Bormed HE9621-PH is a high density polyethylene with narrow molecular weight distribution typically used in injection moulding of articles requiring medium flow with high rigidity. This grade is designed for articles which require high stiffness and low warpage. Material can be sterilised with ethylene oxide, steam and radiation up to 35 kGy; as a result of sterilisation by radiation some minor yellowing can occur. Borealis prohibits the use of any grade product in an implantable device that is introduced into the human body by surgical intervention and that is intended to remain in place following the surgical procedure, e.g. stents, pacemakers. A filled-in Risk Assessment Form and its corresponding approval by Borealis is needed for material sampling and for every Healthcare application.