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DURACON® POM PM Series for Medical Applications


Polyplastics Develops New "DURACON® POM PM Series"

For Medical / Healthcare Industry


The Polyplastics Group has served the medical and healthcare market for many years with its high-purity material TOPAS® cyclic olefin copolymer (COC). Drug contact and delivery are among the highly technical applications for this medical plastic with global medical and food regulatory compliance.

In the growing and changing market, medical device manufacturers and end users demand for high quality materials by a reliable supplier.

As a leading manufacturer of polyoxymethylene (POM) material, Polyplastics now aims to add DURACON® POM "PM Series" to its medical portfolio.

 

The first to come out under the PM Series is the grade named "PM09S01N". This grade will hold features that meet medical device manufacturers' requirements as follows:


1. Agency Compliance

 

-  ISO10993 and USP Class VI biocompatibility/cytotoxicity

-  FDA Drug Master File (DMF) and Device Master File (MAF)

-  EU 10/2011 and FDA food contact 21 CFR 177.2470

2. Quality Management System

 

-  Conformity to VDI guideline "VDI 2017 Medical-grade Plastics"

-  Full traceability of processes and products

-  Production management based on GMP principle

3. Product Supply

 

-  Global supply with uniform quality

 

Listed below are the physical properties and molding properties of the grade PM09S01N.



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For more details, please log in to our online technical support system "WEB@TSC".




DISCLAIMER: DURACON® POM is not designed for use inside of the human body. Please do not use DURACON POM materials for implant applications such as artificial joints, bone reinforcement, dental implants, etc.


18th January 2019