STC's Biocompatibility Testing services for medical devices includes: 

Cytotoxicity Study Test (3 weeks lead time)

• MTT Method (ISO 10993-5)
• Agarose Overlay Method (ISO 10993-5 / USP 87)
• Filter Diffusion Method (ISO 10993-5)
• Direct Contact Method (ISO 10993-5 / USP 87)
• MEM Method (USP 87)

Irritation & Skin Sensitization Test

• Skim Sensitization Study (GPMT / Closed-patch) (ISO 10993-10) (6 - 8 weeks)
  
• Skin Irritation Test (ISO 10993-10) (3 weeks)
• Intracutaneous (Intradermal) Reactivity Test (ISO 10993-10 / USP 88) (3 weeks)
• Oral Mucosa Irritation Test (ISO 10993-10) (8 - 10 weeks)
• Vaginal Irritation Test (ISO 10993-10) (8 - 10 weeks)
• Penile Irritation Test (ISO 10993-10) (8 - 10 weeks)
• Rectal Irritation Test (ISO 10993-10) (3 months)
• Ocular Irritation Test (ISO 10993-10) (3 - 4 weeks)

Systemic Toxicity Test

• Acute Systemic Toxicity Test (ISO 10993-11 / USP 88) (3 weeks)
• Subacute Systemic Toxicity Test (14 days / 28 days) (ISO 10993-11) (6 or 8 weeks)
• Subchronic Systemic Toxicity Test (90 days / 180 days) (ISO 10993-11) (5 or 8 months)
• Pyrogen Test (ISO 10993-11) (3 weeks)

Local Effects after Implantation Test (ISO 10993-6) (at least 4 weeks)

• Implantation in Subcutaneous Tissue Test
• Implantation in Muscle Test 
• Implantation in Bone Test 

Interactions with Blood Test (2 weeks)

• Hemolysis Test (ISO 10993-4 / GB)
  
• Hemolysis Test (ASTM F756)
• APTT、PT、TT、FIB (ISO 10993-4 / GB)
• Platelet Count Test
• Complement Test (ISO 10993-4 / GB)
• Thrombosis Test (in Vivo / in Vitro) (ISO 10993-4 / GB)

Genotoxicity Test (ISO 10993-3)

• Ames Test (8 weeks)
  
• Mouse Lymphoma Assay Test (10 weeks)
• Chromosome Aberration Test  (10 weeks)

For more information about our Biocompatibility services, please feel free to Contact Us.

OTHER TESTING SERVICES

Biocompatibility

Microbiological

Chemical

Safety & Performance

Electromagnetic Compatibility

Optics & Environmental Reliability

Large Animal Test