Physicochemical Testing (Medical Devices)

Physicochemical Testing (Medical Devices)

Physicochemical testing is an integral part of Medical Device Testing. It verifies the chemical composition and physical properties of medical devices to ensure they are safe and suitable for their intended use. These tests are a critical component of biocompatibility evaluation.

Testing covers extractables, leachables, pH, osmolality, and particulate matter testing to ensure compliance with ISO 10993 and other applicable standards for medical devices used in patient care.

Tests Performed

• Extractables and leachables profiling
• pH of extracts
• Osmolality and osmolarity
• Particulate matter (visible and subvisible)
• Heavy metals in extracts (ISO 10993-18)
• Non-volatile residue (NVR)
• Total organic carbon (TOC)
• Colour and clarity of extracts
• Reducing substances
• UV absorbance

Device Types Tested

• IV bags, tubing, and infusion sets
• Syringes, needles, and catheters
• Implantable devices
• Wound care and dressing materials
• Surgical instruments and gloves
• Drug delivery devices
• Packaging materials in contact with drugs

Standards & Compliance

All physicochemical testing is conducted per ISO 10993-1 (Biocompatibility evaluation), ISO 10993-12 (Sample preparation), ISO 10993-18 (Chemical characterization), USP <661>, USP <87>, and other applicable pharmacopoeial and ISO standards.