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What is material characterization and how to use it to supplement your safety evaluations
Material characterization involves testing medical devices to identify any extractable or leachable compounds. Extractables are compounds extracted from materials under exaggerated conditions, while leachables are extracted under clinical simulated conditions. Tests such as FTIR, HPLC/GC, and LC/MS can identify compounds, which are then evaluated for toxicological effects. For one device, 0.0033 mg of di-n-butyl phthalate was extracted. With a human daily exposure of 0.000047 mg/kg and NOAEL of 152 mg/kg, the margin of safety is calculated as 3234042 without additional factors. Material characterization helps supplement safety evaluations for medical devices.
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Similar to What is material characterization and how to use it to supplement your safety evaluations
What is material characterization and how to use it to supplement your safety evaluations
- 2. What is materialcharacterization and how to use it to supplement your safety evaluations Thor Rollins Biocompatibility Specialist Nelson Laboratories, Inc.
- 3. Extractables and Leachables Thor RollinsB.S. RM(NRM) Section Leader Nelson Laboratories, Inc. 801-290-7832 trollins@nelsonlabs.com
- 4. Extractable: Compounds thatcan be extracted from materials or contaminates of a medical device under exaggerated conditions. Leachable: Compounds that can be extracted from materials or contaminates of a medical device under clinical simulated conditions. Copyright Nelson Laboratories 2014 4
- 5. Material Characterization ISO 1099318 FTIR Leachables testing USPclassification of plastics HPLC/GC LC/MS and GC/MS ISO 1099317 LOAEL- Lowest observed adverse effect level NOAEL- No observed adverse effect level Identify compounds in the chemistry and determine toxicological effect with dose and route. Copyright Nelson Laboratories 2014 5
- 6. Material Characterization A samplewas extracted in hexane and we received 53 µg/L. One device was extracted in 62 mL, so to correct for units we: 53 µg x 0.062 ÷1000= 0.0033 mg Copyright Nelson Laboratories 2014 So the tests show 0.0033 mg off of one device 6
- 7. Material Characterization Human DailyExposure (HDE) takes the amount of the device and divides by 70kg for average human body weight. Ex: 0.0033 ÷ 70 kg body weight = 0.000047 mg/kg maximum exposure Compound di-n-butyl phthalate (DBP) CAS No. 84-74-2 Maximum Extractable Level (mg/device) 0.0033 Copyright Nelson Laboratories 2014 Calculated HDE values (mg/kg body weight) 0.000047 7
- 8. Material Characterization • TOXNET CopyrightNelson Laboratories 2014 8
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- 13. Material Characterization Human DailyExposure (HDE) takes the amount of the device and divides by 70kg for average human body weight. Ex: 0.0033 ÷ 70 kg body weight = 0.000047 mg/kg maximum exposure Compound di-n-butyl phthalate (DBP) CAS No. 84-74-2 Maximum Extractable Level (mg/device) 0.0033 Calculated HDE values (mg/kg body weight) 0.000047 Copyright Nelson Laboratories 2014 NOAEL 152mg/kg 13
- 14. NOAEL:152mg/kg Our HDE:0.000047mg/kg Our Marginof Safety without factors:3234042 Copyright Nelson Laboratories 2014 14
- 15. References • ANSI/AMMI/ISO 10993 –ISO 10993-1: Evaluation and Testing – ISO 10993-3: Genotoxicity/Carcinogenicity – ISO 10993-4: Hemocompatibility – ISO 10993-5: Cytotoxicity – ISO 10993-6: Implantation – ISO 10993-10: Sensitization/Irritation – ISO 10993-11: Systemic Toxicity – ISO 10993-18: Biological Evaluation of Medical Devices Copyright Nelson Laboratories 2014 15
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