Medical devices require materials that meet regulatory compliance requirements. Curbell Plastics supplies plastic sheet, rod, and tube materials to meet a variety of compliances including FDA, USP class VI, ISO 13485, and ISO 10993 for medical device manufacturers.
Whether your manufacturing surgical instruments, sterilization trays, or diagnostic equipment, our ISO 9001:2015 certified facilities meet the most rigorous quality management documentation requirements ensuring lot and batch traceability for your applications.
Medical device manufacturers rely on thermoplastic materials for their:
- Design flexibility
- Light weight
- Resistance to chemicals and repeated sterilization cycles
- High-temperature performance
- X-ray opacity
- Hydrophilicity or hydrophobicity
- Welding capabilities
Plastic applications for medical devices include:
- Dental and surgical instrumentation
- Diagnostic equipment
- Patient positioning devices
- Sterilization trays
- X-ray imaging equipment
Plastic materials used in medical device applications include:
The medical industry relies on durable sterilization trays and lids to protect surgical instruments and other healthcare supplies. Plastics for medical trays, lids, and caddies have good hydrolytic and thermal stability for steam sterilization resistance, superior ergonomics, and are available in many colors.
Curbell supplies autoclavable materials such as Ultem®, PSU, PPSU, and PEEK. Medical grade heat-stabilized polypropylene also has good hydrolytic stability and can withstand approximately 200 autoclave cycles. PPSU can withstand approximately 1,000 autoclave cycles under typical conditions. PPSU, Ultem®, and heat-stabilized polypropylene are often specified for sterilization tray applications.
Medical grade plastic materials used in sterilizable medical devices, trays, caddies, and lids:
Sterilizable medical grade plastics are engineered to meet certain standards for biocompatibility including ISO 10993 and USP Class VI.
Ultem®, PPSU, and PEEK also have good resistance to ethylene oxide sterilization.
Dental and surgical instrumentation
Dental and surgical instruments utilize plastic materials for their good ergonomics, sterilizability, machinability, and light weight – allowing the instruments to be handled more precisely. Grips and handles for surgical and dental instruments are frequently machined from medical grade plastic materials.
It is important that healthcare professionals can clearly distinguish between surgical apparatuses and the surrounding body tissue during image-controlled procedures. X-ray opaque plastics for the medical industry are specially formulated for excellent visibility on x-ray and fluoroscopic displays.
X-ray opaque plastic materials designed for use in medical devices and surgical instruments:
Mechanical strength, water absorption, lubricity, wear resistance, and x-ray opacity are important considerations when selecting materials for dental and surgical instrumentation components.
Radiology and medical imaging equipment
Medical imaging equipment manufacturers rely on high-performance engineering thermoplastics like PEEK and Ultem® for critical components in a variety of technologies including:
- Magnetic resonance imagery (MRI)
- Computed tomography (CT)
- Positron emission tomography (PET)
- Biopsy units
Patient support structures and contact surfaces can be manufactured from plastic materials with good durability, surface textures, and resistance to cleaning chemicals. Wheelchair manufacturers rely on thermoformable plastics such as ABS and KYDEX® Thermoplastics for their light weight and ease of manufacturing.
Medical plastics compliance table
The below table provides reference to a few of the medical grade materials mentioned and what compliances they meet.
*The ISO 10993 series of standards include various evaluations of the biocompatability of medical devices to manage biological risk within a risk management process. Compliance to any particular standard, such as ISO 10993-5 or ISO 10993-10, can only be affirmed by the manufacturer.
NOTE: Compliances may vary depending on the exact grade and product color.
Fabrication and machining services
Take advantage of our plastic fabrication and machining services to save time and money on plastic parts. Utilizing in-house capabilities and partnering with fabrication specialists we provide customers with reliable fabrication solutions, machined parts and cut-to-size materials for any application.
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