Biocompatibility and Toxicological Testing- As Per ISO 10993-1:2025
- Extractables & Leachable (E&L) Analysis with Toxicological Risk Assessment (TRA) according to ISO 10993-18 (Chemical Characterization) and ISO 10993-17 with reference to EU MDR Annexure-I &
- Annexure-II by EURO-TOX and ERT Qualified Toxicologist
- Acute Particulate Matter Evaluation for Intravascular Catheters (ASTM F2743 / ASTM F2394)
- PM analysis of Critical Medical device as per USP <788>
- ISO 18562-1:2024 Evaluation within Risk Management Process of Breathing Gas Pathway Devices
- ISO 18562-2:2024- Tests for Emissions of Particulate Matter (Particle release)
- ISO 18562-3:2024- Tests for Emissions of Volatile Organic Compounds (VOCs)- Chemical emissions
- ISO 18562-4:2024 Tests for Leachable in Condensate- Water-soluble contaminants
- ISO 11979-5:2020 – Ophthalmic Implants — Intraocular Lenses (IOLs) — Part 5: Biocompatibility
- ISO 11979-5:2020 physicochemical characterization package for an Intraocular Lens (IOL), including Exhaustive Extraction, Leachables, Hydrolytic Stability, Photostability, Evaluation of Insoluble Inorganics,
- Nd:YAG Laser Exposure, and Toxicological Risk Assessment (TRA)
Biocompatibility And Toxicological Testing- As Per ISO 10993-1:2018
