AMERICHEM MEDICAL-GRADE PLASTIC COMPOUNDS FOR THE HEALTHCARE AND MEDICAL DEVICE INDUSTRY

Medical-grade plastics refer to plastics specifically designed to manufacture medical devices and products. The use of biocompatible plastics in the medical field is aimed at promoting healing and recovery without causing adverse effects such as injuries, allergic reactions or toxic reactions.

For plastic to be considered medical-grade, its biocompatibility with living human cells, tissues and organs must be verified through rigorous testing. Testing a material’s biocompatibility varies depending on the type of device and whether it will come in no contact, short contact or prolonged contact with the human body.

The U.S. Food & Drug Administration (FDA) highly regulates medical devices to ensure their safety and effectiveness. Before a company can legally sell a medical device in the U.S., the device must gain FDA approval by meeting stringent design, material, process and packaging regulations. The FDA recognizes ISO 10993 and USP Class VI as respected consensus standards and test methods used to evaluate the biocompatibility of medical devices to manage biological risk.

How does Americhem Healthcare help its customers achieve ISO 10993-5 compliance?

Americhem Healthcare follows the guidelines and requirements of ISO 10993 as the basis for selecting the most appropriate medical-grade plastic for a customer’s unique application, carefully considering the end product’s expected duration of contact with biological tissues. Our material scientists augment those resins with product additives to achieve specific desired properties. Americhem is highly experienced with sourcing and processing biocompatible plastics that comply with the ISO 10993-5 standard. We perform a variety of tests, including ISO 10993-5 in vitro cytotoxicity tests, on final compounds to verify our materials’ biocompatibility with the human body. Our regulatory and material specialists work closely with our customers, providing all required documentation to prove the finished materials used to manufacture their products are ISO-certified compounds.

Can Americhem Healthcare help global customers achieve different types of regulatory compliance?

Absolutely! Our specialists have in-depth knowledge of healthcare and medical device certification standards around the globe. They can provide advice, guidance and documentation to ensure you receive medical approval in your particular market and country. We routinely develop custom plastic for healthcare devices that adheres to FDA, ASTM, ISO, MEDDEV, CMDR and ARGMD standards, among others.

What types of polymers are suitable as medical-grade plastics?

There are many types of plastics with suitable inherent properties and medical grades that can be used in healthcare and medical device applications. Americhem can customize the following medical-grade polymers with the exact features and performance requirements required for your application:

• Polyethylene (PE)
• Polypropylene (PP)
• Polyvinyl chloride (PVC)
• Polyurethane (PU)
• Polyether ether ketone (PEEK)
• Polyethylene Terephthalate (PET)
• Polyamide (PA)
• Polycarbonate (PC)
• Polyetherimide (PEI)
• Polystyrene (PS)
• Polyethersulfone (PES)
• Polymethyl methacrylate (PMMA)
• Polysulfone (PS)
• Acrylonitrile butadiene styrene (ABS)

What are some of the advantages of medical-grade plastics?

Many healthcare and medical device products come in direct contact with the human body, inside and out. Plastic or other materials that are not designed to be biocompatible can pose a great risk to patients and have devastating consequences. Biocompatible plastics are often specified over metal and other materials because they have inherent properties that make them more suitable for the manufacturing and use of medical products.

• Greater Safety – Medical-grade plastic for medical devices and healthcare undergoes stringent testing such as ISO 10993-5 cytotoxicity testing which employs cell culture techniques to determine whether the materials and their extracts cause cell damage, inhibition or death.
• Infection Resistant – Some medical-grade plastics contain infection-resistant properties that can be enhanced with antimicrobial additives to resist the growth of bacteria on surfaces.
• Durable, Chemical Resistant and Heat Resistant – Inherent properties like durability, chemical resistance and heat resistance can be optimized with different combinations of high-grade additives.
• Versatile – Medical-grade plastics are highly moldable, allowing them to be manufactured into different shapes. From disposable medical products to implantable devices, biocompatible plastic has become the material of choice for a broad range of applications.
• Cost-effective – Medical-grade plastics have a generally low material cost. They are designed to endure over time and will not corrode like metal or shatter like glass. Their ability to withstand repeated sterilizations enables operational savings.
• Recyclable – Certain medical-grade plastics can be remelted and reused during the manufacturing process to eliminate waste, and many are recyclable after the product’s end of life.

Americhem Healthcare partners with a wide range of medical OEMs, developing innovative biocompatible plastic solutions for implant devices, surface devices, externally communicating devices and surgical tools. Explore how we create custom medical-grade compounds used in medical device housings and enclosures, labware and diagnostics equipment, respiratory and oxygen delivery products and surgical instruments.