Get your products to market faster through our comprehensive and customizable extractables and leachables (E&L) testing services. Our experts work directly with regulators to participate in standard-setting activities for ISO 10993-18 and ISO 10993-17, which articulate the framework for the medical device industry to meet safety testing needs through the use of analytical chemistry and biological/toxicological assessment.
To evaluate safety through a risk-based process, chemical characterization data (regarding the chemicals that may leach from a medical device and come in contact with a patient) serves as the primary source of information. Material characterization is particularly critical for combination products, implantable devices, external communicating devices and devices that use color additives or colorants.
We provide a complete suite of extractables and leachables (E&L) testing for medical devices, and our capabilities include chemical characterization in biological evaluation.
Biological Evaluation of Medical Devices
ISO 10993 biocompatibility consists of:
- Part 1: Evaluation and testing within a risk management process
- Part 2: Animal welfare requirements
- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Part 4: Selection of tests for interactions with blood
- Part 5: Tests for in vitro cytotoxicity
- Part 6: Tests for local effects after implantation
- Part 7: Ethylene oxide sterilization residuals
- Part 9: Framework for identification and quantification of potential degradation products
- Part 10: Tests for irritation and skin sensitization
- Part 11: Tests for systemic toxicity
- Part 12: Sample preparation and reference materials
- Part 13: Identification and quantification of degradation products from polymeric medical devices
- Part 14: Identification quantification of degradation products from ceramics
- Part 15: Identification and quantification of degradation products from metals and alloys
- Part 16: Toxicokinetic study design for degradation products and leachables
- Part 17: Establishment of allowable limits for leachable substances
- Part 18: Chemical characterization of materials
- Part 19: Physicochemical, morphological and topographical characterization of materials
- Part 20: Principles and methods for immunotoxicology testing of medical devices
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