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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