Medical Device Evaluation

The PPS toxicological experts with their decades of experience in Biocompatibility & Toxicological Risk Assessments (TRA) provides more integrated and acceptable strategies & evaluation

Biocompatibility testing:

→  Cytotoxicity – ISO 10993-5

→ Genotoxicity – ISO 10993-3

→ Hemocompatibility – ISO 10993-4

→ Irritation – ISO 10993-10

→ Sensitization – ISO 10993-10

→ Systemic Effects or Systemic Toxicity and Pyrogenicity – ISO 10993-11

→ Implantation – ISO 10993-6

→ Toxicological Risk Assessment – ISO 10993-17

PPS offers chemical characterization: Extractables & Leachables (E&L) analysis & Toxicological Risk Assessments (TRA) for medical devices according to ISO & ASTM include:

→ Chemical Characterization of Materials (ISO 10993-12, 18, 19)

          → Determination of Tolerable Intake for Extractable Substances (ISO 10993-17 & ASTM)