An Updated Approach to Extractables and Leachables Testing per ISO 10993–18:2020
Patient safety is always the number one priority. Therefore, medical device manufacturers must ensure that their products do not contain any potentially harmful chemicals that might have found their way into formulations during the packaging or storage processes, or that might be leached from the device during its use in a clinical setting.
This is where ISO 10993-18:2020 guidance comes in. Building on the foundations stipulated in ISO 10993-18:2005, this latest version – published in January 2020 – outlines the chemical characterization (aka E&L) tests that medical device manufacturers must undertake to support the biological safety of their devices.