Medical Polyoxymethylene: A Versatile Material for Medical Devices and Implants

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Given its unique properties and processing versatility, Medical Polyoxymethylene finds

Medical Applications

Given its unique properties and processing versatility, Medical Polyoxymethylene finds widespread use in medical devices and implants. Common applications include:

- Surgical instruments: Handles for scalpels, forceps and retractors utilizing POM’s high strength, durability and autoclavability.

- Diagnostic devices: Sample holders, test tubes, pipette tips and labware take advantage of POM’s chemical resistance, dimensional stability and lubricity.

- Dental appliances: Dentures, bridges and orthodontic aligners using Medical Polyoxymethylene biocompatibility for direct body contact.

- Prosthetics: Socket liners, artificial joints and articulating components leverage POM’s self-lubricity and impact resistance.

- Implants: Housings and chambers for pacemakers, neurostimulators and drug delivery pumps due to hemocompatibility.

- Ophthalmic devices: Intraocular lenses, contact lenses and other implants relying on POM’s transparency, stability and non-absorbability.

- Dialysis equipment: Hemodialysis circuits, bloodlines and connectors using chemical resistance and autoclavability.

Regulatory Compliance

Given its long history of safe medical use, POM complies fully with worldwide regulations for implant-grade materials. It meets the biocompatibility testing outlined in ISO 10993 consisting of cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation and material-mediated pyrogenicity.

POM is listed in the FDA compliant Plastics Toolkit and conforms to individual regulations including USP Class VI and EC Norm EN ISO 10993. It complies with the European CE Marking Directive as a Class IIa implant material. POM also meets the ISO 60601 and ISO 15747 guidelines for electrical insulation, fire resistance and welding/sealing of hospital equipment.

 

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