Geneva Laboratories, Inc. Medical Device, Pharmaceutical and Personal Care Testing Biocompaibility Testing Services pre-market approval 510K FDA ISO product safety finished product GLP portion intravenous parenteral topical oral optical body cavity acute systemic toxicity ames mutagenicity chronic cytotoxicity dermal sensitization hemolysis implantation intracutaneous injection pyrogenicity subchronic glp biocompatibility matrix requirements

Testing Services
Biocompatibility

Biocompatibility testing seeks to determine a material’s capability to remain unreactive biologically throughout the duration of body contact. If a product / device is on track for a Pre-Market Approval (PMA) or 510k submission, the biocompatibility requirements must be addressed.

USP <1031> THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS and ISO10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing provide specific direction when evaluating testing required for biological reactivity. The nature of intended body contact, along with contact duration determines which test methods must be evaluated.

While testing raw materials and components can offer valuable information, data used for submittal purposes must be gathered from testing finished, and sterilized product.

The following Biocompatibility Tests are offered at Geneva Laboratories:

Acute Systemic Toxicity

Intracutaneous Injection

Pyrogenicity

Subchronic Toxicity

** GLP **