Duracon PM09S01N

Duracon PM09S01N is an unfilled POM Co-polymer (MFR 9) that has been designed specifically for use in Healthcare applications.

Key Features:

• Available in WK2001 natural
• ISO10993 & USP Class VI biocompatibility/cytotoxicity
• FDA Drug Master File (DMF) & Device Master File (MAF)
• EU 10/2011 & FDA food contact 21 CFR 177.2470
• Follows change control and GMP principles (NOC period to be discussed with Polyplastics)
• Full traceability of processes and products
• Uniform quality and global supply
• Sterilisation suitable under hot steam autoclave 121C and 135C & EOG
• Excellent heat & moisture durability in comparison to grades from competitors
• Low level of extractables in comparison to grades from competitors

POM is not suitable to be gamma irradiated or under E-beam

Target Applications:
-Drug Delivery Devices > Insulin pens, insulin pumps, inhalers
-Medical Instruments, IV clips, three-way cocks, catheter control handles, surgical instruments & scissors, syringe parts, infusion pump parts & any 'moving' parts within medical devices/instruments

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. Polyplastics will not support Risk Class III applications.