Biocompatibility
Liveon Biolabs has years of experience in conducting Biocompatibility tests and is accredited ISO/IEC 17025: 2005 for testing of medical devices. Our expert scientists carefully evaluate your device for its biological compatibility as per ISO, US FDA guidelines for CE Marking and regulatory approvals.
Biocompatibility Tests at Liveon Biolabs
Test for in vitro Cytotoxicity (ISO 10993-5)
- Agarose Overlay
- MEM Elution
- Direct Contact
- Quantitative Test by MTT Test
Tests for irritation and skin sensitization (ISO 10993-10 and USP)
- Intracutaneous Reactivity
- Mucosal Irritation (vaginal, rectal, oral)
- Ocular Irritation
- Intraocular Irritation
- Closed Patch (Buehler) Dermal Irritation
- Guinea Pig Maximization Test
- Local Lymph Node Assay (LLNA) by BrdU ELISA
Test for Systemic Toxicity (ISO 10993-11)
- Acute Systmeic Toxicity
- Sub-Acute Toxicity
- Sub-chronic Toxicity
- Chronic systemic toxicity
- Reproductive Toxicity
Tests for genotoxicity (ISO 10993-3)
- Bacterial Reverse Mutation Test (Ames test)
- in vitro Mammalian Chromosome Aberration Test
- in vitro Micronucleus Test
- in vivo Mammalian Erythrocyte Micronucleus Test
- in vivo Mammalian Bone Marrow Chromosome Aberration Test
Tests for reproductive toxicity (ISO 10993-3)
- Reproductive and Developmental Toxicology Studies
Tests for carcinogenicity (ISO 10993-3)
Hemocompatibility (ISO 10993-4)
- ASTM Hemolysis
- Prothrombin time (PT)
- Complement assay (C3a and SC5b-9)
- Partial thromboplastin time (PTT)
- Thrombin time (TT)
Tests for local effects after implantation (ISO 10993-6 and USP)
- Intramuscular Implantation
- Subcutaneous Implantation
- Bone Implantation
- Ocular Implantation
Pyrogenicity
- Rabbit Pyrogen Test
- Rabbit Pyrogen - Material Mediated
USP Plastics (USP Class (I-VI))
- USP I-VI
- USP Systemic Injection Test
- USP Intracutaneous Test
- USP Implant Test
- USP Safety Test
Sterility Test
Bioburden Test
Bacterial Endotoxin Test