Biocompatibility & Toxicology (ISO 10993 Series)
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation & Intracutaneous Reactivity
- Acute, subacute, subchronic, and chronic systemic toxicity
- Genotoxicity (Ames test, chromosomal aberration)
- Carcinogenicity studies
- Reproductive & developmental toxicity (ISO 10993-3)
- Hemocompatibility (ISO 10993-4)
- Implantation studies
- Pyrogenicity (rabbit test, LAL)
- Chemical characterization (ISO 10993-18)
- Toxicological risk assessment (ISO 10993-17)
Dental Material Testing
- Compressive & flexural strength (ISO 4049, ISO 9917-1)
- Wear resistance and hardness
- Water sorption and solubility
- Bond strength to tooth structure (shear, tensile)
- Color stability and optical properties
- Radiopacity testing (ISO 6876, ISO 4049)
- Biocompatibility and cytotoxicity specific to oral mucosa
- Surface roughness and polishability
- Fluoride release (for glass ionomer cements)
- Thermocycling resistance testing
- Adhesive/dentin interface testing
- Antimicrobial activity of dental materials
Laser and LED Device Testing
- IEC 60825-1: Laser safety classification & labeling
- IEC 60601-2-22: Particular requirements for medical lasers
- LED emission testing and photobiological safety
- Wavelength verification and energy output testing
- Beam profile and divergence analysis
- Hazard zone mapping
- Eye safety and retinal exposure assessments
- Skin exposure and thermal hazard testing
- Fiber-optic and delivery system safety
- Compliance with ANSI Z136 laser safety standards
- IEC 62471: Photobiological safety of lamps and lamp systems (for LED/UV devices)
Microbiological Testing & Sterilization Validation
- Bioburden testing (ISO 11737-1)
- Sterility testing (USP <71>)
- Bacterial endotoxin (LAL testing)
- Reprocessing validation (AAMI TIR30, ISO 17664)
- EO residuals (ISO 10993-7)
- Antimicrobial surface testing
- Antiviral efficacy testing
- Validation of cleaning/disinfection protocols
- Validation of reusable device instructions
Material & Chemical Testing
- Extractables and leachables (E&L studies)
- Residual solvents (USP <467>)
- Heavy metals and elemental impurities (ICP-MS, ICH Q3D)
- FTIR, DSC, TGA, and other material characterization
- Surface energy and adhesion testing
- Particulate matter testing (USP <788>, <789>)
- Corrosion and galvanic compatibility
- Environmental stress cracking (ESC)
Mechanical & Performance Testing
- Tensile, flexural, and fatigue testing
- Simulated use and functional testing
- Insertion and removal force (e.g., catheters, needles)
- Trackability, torquability, and kink resistance
- Burst, leak, and seal integrity
- Valve performance and backflow testing
- Actuation force (e.g., auto-injectors)
- Wear and abrasion resistance
- Sharpness and penetration force testing
- Deployment/retraction testing for implants
- Balloon compliance and burst testing
Packaging & Labeling Validation
- Accelerated aging (ASTM F1980)
- Real-time shelf-life studies
- Seal strength testing (ASTM F88)
- Dye ingress and bubble leak (ASTM F1929 / F2096)
- Drop, vibration, and impact testing (ISTA/ASTM D4169)
- Label legibility and adhesion testing
- Tamper-evidence and traceability verification
Environmental, Thermal, and Transport Simulation
- Thermal shock and temperature cycling
- High/low humidity and temperature exposure
- Altitude simulation
- RTCA DO-160G for airborne equipment
- UV and light exposure testing
- Vibration testing (random, sine)
- Drop testing for packaged products
- Climatic chamber testing for storage stability
Electrical & Electromagnetic Compatibility
- Electrical safety (IEC 60601-1)
- EMC testing (IEC 60601-1-2)
- MIL-STD-461
- Wireless coexistence (per FDA guidance)
- Battery testing (IEC 62133, UN 38.3)
- Electrical leakage, insulation resistance, and grounding tests
Specialized Device-Specific Tests
- MRI safety and artifact testing (ASTM F2503)
- Joint simulation testing for orthopedic implants
- Flow rate and occlusion testing (e.g., infusion pumps)
- Intraocular lens testing (ISO 11979 series)
- Hearing aid/acoustic testing (IEC 60118)
- Endoscope durability testing (twist, bend, flex)
- Ophthalmic instrument testing (ISO 15004)
- Alarm systems (IEC 60601-1-8)
- Infusion pump alarm and safety testing