Medical grade plastics must be FDA and USP Class VI certified. USP stands for U.S. Pharmacopoeia. For a plastic to be USP Class VI certified it means it has passed testing to be used in medical devices and procedures. The specific tests are done to record biological reactions to plastics in the human body.
Acute Systemic Toxicity Test – Tests the irritation caused by the product through dermal, oral, and inhalation exposure.
Intracutaneous Test – Testing is done on specific tissues the product will be exposed to without any protection from body systems.
Implantation Test – Materials being tested are directly implanted in live tissues to determine reaction and toxicity potential over a 5 day period.
Standard Temperature & Times – Material is exposed to three different temperatures for a specific amount of time.
122⁰F / 72 hours
158⁰F / 24 hours
250⁰F / 1 hour
In addition to tests performed by the USP and FDA plastics used in the medical field must meet certain standards. Plastics must be compatible with the sterilization chemicals, body fluids, and chemicals they come in contact with.
Plastic Requirements:
Material Characterization
Sterilization Resistance
Chemical and Lipid Resistance
Extractable/Leachable Characterization
Biocompatibility/Hemocompatibility
Shelf Life and Stability
These are the most prevalent plastics used in the medical industry:
PEEK (polyetheretherketone)
Polyetherimide
Acetal Copolymer
Heat Stabilized Polypropylene
PolyEtherSulfone
Polyphenylene Oxide & Styrene
Polycarbonate
Polystyrene
