SO 10993-18 – Biological Evaluation Of Medical Devices

ISO 10993-18 defines standards for identifying biological hazards and risks in the chemical makeup of medical devices. Through chemical characterization and biological evaluation of medical devices, manufacturers must, in order to meet FDA compliance, test and evaluate for the potential of extractables and leachables to adversely affect the health of end users. ISO 10993 Part 18 provides a testing and identification framework to do so.

Extractables and leachables are chemical elements or components that may be transferred from medical devices into the materials with which patients, handlers, end users, and others may interact. This transfer may occur through normal usage (such as storage of medicine within a medical device like a syringe or test tube), or through exposure to extreme elements such as heat, UV, or cold.

ISO 10993-18 testing for extractables and leachables should be conducted for any material that may come into contact with medical materials or end users, including:

  • Tubing
  • Bags
  • Filters
  • Pumps and pump components
  • Bottles
  • Caps
  • Vials
  • Seals
  • Stents
  • Syringes
  • And more

Biocompatibility testing for medical devices should occur for any materials and products that may come into contact with the patient, or that may come into contact with any material with which the patient will interact (such as medication).

Testing for Extractables

Testing for extractables in medical devices involves subjecting the testing subject to exhaustive extraction for hazard identification. Depending upon the expected application and usage scenarios of the product in question, not every test may be required, but it is critically important to ensure that tests are carried out whenever there is a chance that a certain scenario may be encountered. Depending upon the chemical makeup of the materials in use, as determined by characterization testing, different testing parameters and simulations may be necessary. In general, testing should cover all chemical compound classes, from volatile to non-volatile.

Testing for Leachables

Leachable testing simulates longer-term scenarios in which potentially harmful chemical compounds may leach out of a medical device over time, when subject to specific conditions. Leachable testing entails standard conditions as well as extreme conditions. Testing for leachables should also consider packaging, including inks, dyes, and label. Leachable testing must also account for the chemical properties of the materials being stored in the medical device itself.

These testing processes are critical to ensure the safety of patients, handlers, and other users of medical devices and products. BA Sciences offers deep expertise in this ISO standard for risk identification and assessment, with the ability to design tests and protocols tailored to your operations, keeping your products safe and compliant.

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