Chemical testing for medical devices

Chemical testing is a critical step in helping to ensure patient safety.

Medical devices consist of a structural mix such as metal alloys or polymers that contain a varying degree of additives intended to help them achieve the desired look, feel, and that also help optimize their overall performance.

The physical and chemical characterization of materials has become the first stage of biological evaluation as called for by ISO 10993. This process includes extractables and leachables (E&L) studies, which are critical in helping to ensure product approval.

Extractables and leachables testing is intended to identify and quantify harmful species which could “leach” from medical devices and pose a health risk to users.

ISO10993 defines extractables as the ‘potential impact’, a ‘substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles.’ Leachables are the ‘actual impact’, a ‘substance that is released from a medical device or material during its clinical use.’

In identifying potential sources, it is therefore important to conduct controlled extraction studies to help identify extractables and the components that generate them.

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Complimentary Webinar

Applying ISO 10993-18 on Extractables & Leachables Characterization: Supporting the Medical Device Regulatory Pathway

Watch our complimentary webinar titled Applying ISO 10993-18 on Extractables & Leachables Characterization: Supporting the Medical Device Regulatory Pathway, to learn how using LC-MS solutions that are designed around the E&L workflow allows you to make critical decisions with greater confidence within a compliant environment.

Polymer separation and medical device design »

Characterization is a critical factor in the ultimate design of medical devices that meet performance, lifetime, stability and safety requirements.

Screening workflow for extractables testing »

Access a technical note focused on screening and characterization of medical devices using extractables and leachables testing methods.

Regulations and chemical characterization »

Join Dr. Andrew Feilden for a discussion on the regulatory updates recently made to extractable and leachable analysis requirements (ISO 10993-18).

Device innovation and approval is hard work, finding the right tools shouldn’t be. Contact us today to learn how we can help you accurately and efficiently gain insight into the chemical structure and physical property performance of your medical devices.