Description

Bormedโ„ข LE6609-PH is a low density polyethylene intended for evaluation for use in Healthcare applications. Bormed LE6609-PH is an additive free low density polyethylene typically used in blow moulding (including blow fill seal) articles. It is produced using tubular or autoclave technology. The flexibility of the material facilitates the collapsibility of containers. Bottles and ampoules made from Bormed LE6609-PH can be steam sterilised at temperatures above 110 C or by using ethylene oxide or radiation up to 35 kGy. 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.

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