The Food and Drug Administration (FDA) has partially recognized ISO 10993 guidance, making it one of the most important for chemical characterization testing of medical devices.1 ISO 10993 outlines all the necessary steps for regulatory compliance for using new or existing materials in medical devices.
The potential health risks from a medical device are numerous. Toxic exposure is determined by the exposure time, concentration and severity of the chemical species involved. The FDA seeks to incorporate these risks into proposed chemical characterization tests as part of ISO 10993, depending on where and for how long the medical device will be used.
Chemical characterization testing for medical devices also needs to cover multiple scenarios. This may include extractable tests under exaggerated use conditions or leachable tests in the type of environment the device is exposed to in the body. It may also include chemical characterization testing for worst-case chemical release scenarios.
chemical characteristic test
The first part of chemical characterization testing is to establish what materials will be used in a device. Since ISO 10993 allows existing safety data to be used for further testing when appropriate, it may be more efficient to use established materials, if possible.
Once the equipment structure has been established, an assessment should be made to determine whether residual risk remains. In most cases, material processing and equipment manufacturing present additional risks that new chemicals may be introduced resulting in the need for further chemical characterization testing.
Then, chemical characterization testing is needed to evaluate what would be the worst-case chemical release scenario from a device. Chemical characterization testing for worst-case chemical releases may also include testing for conditions where the equipment is biodegradable or polymerizable in-situ.
Removable and Leachables
At the heart of chemical characterization testing for medical devices are extractable and leachable tests. This chemical characterization test evaluates how much and how quickly compounds can be transferred from the device to the environment.
Sometimes these tests require significant sample preparation to ensure that the chemical characterization test environment is appropriate to represent the usage conditions. Environmental conditions may also need to be adjusted to see the worst-case scenario for a device and to ensure that dangerous levels of a compound are not released.
One of the most important numbers to find in a chemical characterization test is the threshold of toxicological concern. Small amounts of extractable and leachable may not pose a significant health hazard and therefore may be acceptable, but the threshold of toxicological concern must be known to determine this.
With the complexity and broad requirements for chemical characterization testing for medical devices, turn to a specialist partner for help. Jordi Labs is the world leader in biological safety guidance and can provide advice on how to maintain the highest safety standards and achieve regulatory compliance for your new product without losing time to market. Contact Jordi Labs today to find out if our chemical characterization test can help you|