Biocompatibility Testing

Biocompatibility testing services

Eurofins companies offer the full range of Biocompatibility Testing required by the medical device industry. We conduct biological studies according to the matrix of ISO 10993-1, MHLW requirements, and USP classification of plastics, including Class VI and other international guidelines. We have also established a variety of cell-based alternative methods or models under GLP to examine the hazardous effects of medical devices. The most suitable customised test strategy design is chosen depending on the material of the product, manufacturing methods and the aim of the study.

Cytotoxicity

• Growth Inhibition
• ISO/USP Elution
• Quantitative Cytotoxicity Assays (ex: XTT)
• Direct Cell Contact
• Agar Diffusion Test
• Colony Forming Assay

Hemocompatibility

• Dynamic Test Designs
• Chandler-Loop Design
• Agitation Model
• Static Test Designs
• Hemolysis (ASTM and ISO)
• Platelet Count
• PTT
• Thrombogenity
• Complement Activation

Implantation

• Intramuscular, Subcutaneous Implantation
• Bone Implantation
• Animal Performance Studies
• Customized Efficacy Studies
• Efficacy Studies with Systemic
• Toxicology

Sensitization

• Maximization Test (Magnusson & Kligman)
• Closed Patch Test (Buehler)
• Local Lymph Node Assay (LLNA)
• In vitro Sensitization (hCLAT, DPRA, KeratinoSens)

Irritation

• Dermal Irritation
• Intracutaneous Irritation
• Ocular Irritation
• Oral Mucosal Irritation Test
• Penile Irritation Test
• Rectal Irritation Test
• Vaginal Irritation Test
• In vitro Irritation (Episkin and Epiderm)

Toxicity

• Acute Systemic Toxicity
• Systemic Toxicity (Subacute, Subchronic & Chronic)
• Reproductive & Developmental Toxicity
• Inhalation Toxicity
• Carcinogenicity
• Pyrogenicity

Genotoxicity

• Bacterial Mutation - Ames Mutagenicity
• Mammalian Mutation Assay: Mouse Lymphoma Assay
• Chromosome Aberration Test (Chinese Hamster Cell and Human Lymphocyte)
• In vivo Micronucleus Assay
• Micronucleus Assay (Chinese Hamster Cell and Human Lymphocyte)