Medical Device Testing

BIOCOMPATIBILITY TESTING - GLP

• Cytotoxicity
• Qualitative
  • Test on Extracts
  • Direct Contact Method
  • Indirect: Agar Diffusion
• Quantitative
  • NRU Assay
  • MTT Assay
• Mutagenicity
  • AMES Test
  • Chromosomal Aberration Test
  • Micronucleus Test
  • Cell Gene Mutation Test
• Material Mediated Pyrogenecity
• Haemocompatibility
• Toxicity
  • Acute Systemic
  • Sub-Acute Systemic
  • Sub chronic Systemic
  • Chronic Systemic
  • Carcinogenecity
• Skin Sensitisation
  • GPMT (Guinea Pig Maximization Test)
  • Buehler Test
• Implantation
  • Muscle Implantation
  • Subcutaneous Implantation
• Irritation Test
• Intracutaneous (Intradermal) Reactivity Test
• Regulatory Guideline
  • ISO
  • OECD
  • ASTM