by Medical-grade polyoxymethylene (POM), also known as acetal or polyacetal, is an engineering thermoplastic used in a variety of medical devices and applications. This versatile material has outstanding properties that make it well-suited for use in the medical industry.
Physical and Mechanical Properties
POM is a rigid thermoplastic known for its robust stiffness and strength. It has a tensile strength of up to 7,500 psi and tensile modulus of up to 420,000 psi, making it very durable. POM is also tough and impact-resistant, allowing it to withstand drops and collisions. Its coefficient of friction is low, giving components a smooth feel.
Medical Polyoxymethylene a physical standpoint, POM is dimensionally stable and will not warp or distort over time or with changes in temperature and humidity. It has superb chemical resistance and will not degrade when exposed to water, oils, solvents, or disinfecting agents commonly used in medical facilities and operating rooms. POM resists cracking and crazing, maintaining its structural integrity even after years of use.
Biocompatibility for Medical Applications
One key attribute of medical-grade medical polyoxymethylene is its biocompatibility. The material has been verified by independent labs to meet the requirements of ISO 10993 standards for cytotoxicity, sensitization, irritation, systemic toxicity, and more. It shows no long-term toxicity when implanted or used in bodily contact.
POM performs well when sterilized using gamma radiation, EtO gas, autoclaving, or other common sterilization techniques. Its surface resists soiling and cleanup is simple using mild detergents. Also important, POM provides an inert, non-reactive surface that will not corrode, discolor, or degrade medicines or bodily fluids.
Processing Versatility
Another advantage of POM is its ease of processing. It can be machined, molded, joined, and finished using standard thermoplastic techniques. Medical-grade POM is readily moldable using injection, blow, or compression molding processes. It can also be machined or CNC-machined into complex net shapes with tight tolerances.
POM performs well in cleaning and assembly operations. Its finished surfaces provide a smooth, non-porous substrate that is less prone to soiling or bacterial buildup compared to other plastics. It can also be colored, has customizable properties, and readily accepts labeling and identification marks.
Applications in Medical Devices and Equipment
Due to its biocompatibility and engineering properties, POM is increasingly used in medical devices from major components to small accessories. Here are some common applications:
– Surgical and dental instruments: POM is used to create handles, connectors, joints, and housings for forceps, retractors, scalpels, drill bits, and other small tools.
– Diagnostic devices: Housings, hinges, caps, and attachment points on ultrasonic probes, endoscopes, and vital-sign monitors use POM.
– Prosthetics: Parts like socket liners, vacuum rings, and suspension components in artificial limbs rely on POM’s durability and chemical resistance.
– Laboratory/hospital equipment: Specimen containers, centrifuge cradles, test tube racks, IV poles, and furniture components take advantage of POM’s rigidity and non-reactivity.
– Healthcare packaging: Trays, vials, syringe plungers, stoppers, and tubing employ POM for its flexibility in packaging sterilized items.
Meeting Regulatory Requirements
As a critical component in medical devices, medical polyoxymethylene must meet strict material and process controls. Leading suppliers ensure their grades are certified biocompatible per ISO 10993 and comply with relevant parts of ISO 10993 for toxicity, ISO 11014 safety requirements, and USP Class VI biocompatibility criteria.
Traceability of raw materials is maintained from resin production through conversion and packaging. Quality systems are in place for validation, documentation, and change control per ISO 13485 and FDA Quality System Regulations. Sterilization methods like gamma irradiation are validated to sterilize the finished devices without compromising material properties or functionality. Overall, advanced quality oversight enables POM to satisfy regulatory requirements for medical applications.
Medical-grade POM continues expanding into new applications due to performance advantages over traditional plastics like polycarbonate, nylon, and PVC. Ongoing material innovation tailors POM for 3D printing, customized medtech components, and single-use disposable devices. As a proven biocompatible material with inherent toughness, durability and chemical resistance, POM promises to remain a polymer of choice in surgical tools, diagnostic devices, and other healthcare products and equipment for many years to come. Its versatility and reliability make it a valuable material for producing lifesaving and life-improving medical technologies.
About Author - Money Singh
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemicals and materials, defense and aerospace, consumer goods, etc. LinkedIn Profile
