Extractables and Leachables

As part of the evaluation of medical devices, it is important to evaluate the potential for various chemicals to migrate from the container, container closure system or other materials used for a device.  We are able to detect every leachable substance in your product that you must know of.  Testing is conducted in accordance with ISO 10993-18.

While analytical methods and concepts are consistent with extractables and leachables studies for containers and closure systems, quick and affordable solutions are demanded for the comparison of medical device products after design and material changes, change of raw material production lot or ageing. 

No matter what the geometry, material or consistency of your medical device, Product Safety Labs will find a way to prepare, extract and analyze your product in full compliance with ISO 10993-18. 

Let one of our experts at Product Safety Labs help you with your research needs.