Biocompatibility Test Services
Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with a unique set of testing requirements, the biocompatibility testing experience can be intimidating. Even after a device has been categorized, a myriad of decisions for each test remains.
The biocompatibility team at Nelson Laboratories will work with you to develop a comprehensive testing plan that’s right for your product. We’ll also partner with you throughout the testing process, helping you to eliminate time- and resource-draining surprises.
Download the biocompatibility test matrix. [Based on SO 10993-1: 2009/(r) 2013, and FDA Guidance for Industry: Use of International Standard ISO-10993]
Test Categories Include:
- Cytotoxicity: Agar Overlay, MEM Elution
- Sensitization: Buehler Sensitization Method, Local Lymph Node Assay (LLNA), Maximization (Magnus-Kligman)
- Irritation: Primary Skin Irritation, Intracutaneous Reactivity, Ocular Irritation, Oral Mucosal Irritation, Vaginal Irritation
- Systemic Injection: System Acute Systemic Injection, Material Mediated Pyrogen
- Subacute (Subchronic) Toxicity: Subacute Toxicity, Subchronic Toxicity
- Genotoxicity: Ames Mutagenicity, Chromosomal Aberration, Mouse Lymphoma, Mouse Micronucleus
- Implantation: Intramuscular Implantation, Subcutaneous
Hemocompatibility: Hemolysis, PTT, Complement Activation, Dog Thrombogenicity
- ISO 10993
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|CTX110||Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant)||Add|
|CTX115||Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext||Add|
|GTX110||Genotoxicity: Ames Test (Solids), 2 extracts, 5 strains, plate inc.||Add|
|HCX140||Hemocompatibility: Hemolysis, ASTM Method, indirect (human blood)||Add|
|HCX145||Hemocompatibility: Hemolysis, ASTM Method, direct contact (human blood)||Add|
|SCX110||Sensitization: Magnusson-Kligman Method, 2 extracts||Add|
|SCX210||Irritation: Intracutaneous Reactivity (USP), 2 extracts||Add|
|SCX220||Irritation: Intracutaneous Toxicity (ISO), 2 extracts||Add|
|SCX310||Systemic Toxicity: Systemic Injection (ISO), 2 extracts||Add|
|SCX410||Sub-Acute Toxicity: 14 day and 14 dose (mice)||Add|
|SCX650||Implant Study: ISO 13 week, Surgical implant w/ histo, each||Add|
CTX110 - Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant)
CTX115 - Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext
GTX110 - Genotoxicity: Ames Test (Solids), 2 extracts, 5 strains, plate inc.
HCX140 - Hemocompatibility: Hemolysis, ASTM Method, indirect (human blood)
HCX145 - Hemocompatibility: Hemolysis, ASTM Method, direct contact (human blood)
SCX110 - Sensitization: Magnusson-Kligman Method, 2 extracts
SCX210 - Irritation: Intracutaneous Reactivity (USP), 2 extracts
SCX220 - Irritation: Intracutaneous Toxicity (ISO), 2 extracts
SCX310 - Systemic Toxicity: Systemic Injection (ISO), 2 extracts
SCX410 - Sub-Acute Toxicity: 14 day and 14 dose (mice)
SCX650 - Implant Study: ISO 13 week, Surgical implant w/ histo, each
CTX110: 1 complete device, each device must be 120 cm2 or 4 grams
CTX115: 1 complete device, each device must be 120 cm2 or 4 grams
GTX110: 4 complete devices, each >60 cm2 or 2 grams
HCX140: 1 complete device, each device must be 150 cm2 or 5 grams
HCX145: 3 complete devices, each device must be 50 cm2 or 2 grams
SCX110: 6 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT
SCX210: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX220: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX310: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX410: 14 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX650: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
Study OutlineThe three most common biocompatibility tests every medical device must be subjected to are cytotoxicity, sensitization and irritation. Each test screens for the presence of toxic, leachable materials. Based on the category of the device, as many as five additional different testing categories may be required (see test matrix).
Occasionally a product will fail a test, but this doesn’t mean the end of the line for your device. We can help you determine the cause of a failure and what steps to take next. These steps may include:
- Component testing: A failed result may be due to a single component, so we recommend component testing of any failed product. The MEM elution test is an inexpensive and reliable way to identify potential component issues. By identifying component issues early in the process, companies can prevent costly retests or delays on the more expensive and time consuming tests.
- Manufacturing issues: If raw materials are ruled out as a cause for failure, the next area to investigate is the manufacturing process, where additional leachables can be added to the product. Some of the most common problems are inks or adhesives which have not cured completely and residual detergents on the device. Residues can also be added during the sterilization process.
- Evaluating results as a whole: If the raw materials and the manufacturing process aren’t the cause of a failed test, a decision must be made about whether the amount of toxicity is justifiable based on the benefits of the device. A failed test is certainly not the best scenario for submission, but it need not be the end of the road. Biocompatibility testing must evaluate all test results as a whole, and the relationship to the device, its use, benefits and risk.
- Higher-level tests: A failed test result is more likely to be accepted if normal results are shown in higher-level tests (e.g., tests which more directly simulate the product’s use, such as functional implant studies), and if a well-supported, risk assessment-based justification can be written.
Justification: To support such a justification, test results can be compared with results of similar devices which are already on the market (i.e., predicate testing). In addition, dilutions of the device extract can also be prepared and tested to determine an endpoint for the toxicity. This end point determination provides you with a more quantitative perspective as to the concentration of the leachate.