USP Class VI
The U.S. Pharmacopeia (USP), a non-profit organization, establishes standards for medications, food ingredients, dietary supplements, and healthcare technologies. USP publishes biocompatibility protocols for plastics and polymers in medical devices or surgical equipment that may contact human tissue.
USP Class VI, one of the six designations outlined in General Chapter <88> of the United States Pharmacopeia and National Formulary (USP-NF), offers guidelines for testing and certifying materials intended for use in medical devices.
The USP Class VI designation, recognized as the most stringent and hence most applicable for medical use, involves three in vivo biological reactivity evaluations. Typically conducted on mice or rabbits to simulate human use, these evaluations include:
- Acute Systemic Toxicity (Systemic Injection) Test:
Assesses toxicity and irritation through oral administration, skin application, and inhalation of the compound. - Intracutaneous Test:
Evaluates toxicity and localized irritation when the sample comes into contact with live subdermal tissue, specifically the tissue the medical device is intended to interact with. - Implantation Test:
Measures toxicity, infection, and irritation of an intramuscular implantation of the compound into a test animal over several days.
Apart from successfully passing the three mentioned tests to showcase minimal toxicity, the material undergoes specific temperature assessments over designated durations. Meeting USP Class VI standards typically guarantees high quality and enhances acceptance by the FDA and USDA. This adherence significantly lowers the risk of patient harm due to reactions to toxic materials.
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