AN INTEGRATED APPROACH TO MEDICAL DEVICE EXTRACTABLES / LEACHABLES WITH INTEGRATED TOXICOLOGICAL EVALUATION IN ACCORDANCE WITH ISO 10993-18:2020 AND ISO 10993-17:2023.
CHEMTOX™ IS MEDICAL DEVICE CHEMISTRY & TOXICOLOGY SIMPLIFIED.
CREATE A QUOTEExtractables and leachables (E&L) testing is the chemical characterization of a medical device to identify and quantify the chemical constituents that could reach a patient. Extractables are compounds pulled from a material under exaggerated laboratory conditions; leachables are the subset that actually migrate under normal clinical use.
Under ISO 10993-18, these constituents are identified and quantified through chemical characterization; under ISO 10993-17, each is assessed against its toxicological threshold (tolerable intake) to determine whether the device is chemically safe. ChemTox™ integrates both into one streamlined workflow — chemical characterization and toxicological risk assessment in a single, defensible package.
01 - Agree to project scope, develop & document test plan — Client issues Purchase Order.
02 - Submit samples to Groenakker for review.
03 - Groenakker reviews samples & completes sample submission form for client review.
04 - Chemistry Testing is performed at ISO 17025 accredited laboratory per Groenakker's test plan & methods.
05ᵃ - ChemTox™ Review of data for EU MDR compounds incl. CMR & Cohort of Concern.
05ᵇ - Toxicological Risk Assessment generation — derivation of TGₘₐₓ, EEDₘₐₓ, and calculation of MOS (ChemTox™ Plus + ChemTox™ Max only).
06 - Final approved reporting of results to client.
For toxicological risk evaluation, starting with sound chemical data is critical. Through years of method development and validation work, our partner in chemistry testing provides industry-leading turnaround times while reducing or eliminating unknown compounds. State of the art analytical testing with defined uncertainty factors provides a firm foundation for effective risk assessments & provides clients with the confidence needed to support global regulatory submissions.
ChemTox™ leverages deep integrations with our laboratory partner and automated data handling techniques to facilitate thorough and efficient review of identified chemical constituents. By creating bespoke tools, Groenakker enhances the workflow of our DABT-certified toxicologist and provides toxicological risk assessments (TRA) in a fraction of standard industry lead times.
ChemTox™ is designed to remove the guesswork and uncertainty from extractable & leachable studies and provide clients with a clear path to decision making. Chemical analysis and toxicology are integrated to provide an E&L solution which takes weeks to execute, not many months, with budgetary efficiency in mind. As with all activities at Groenakker, ChemTox™ moves at the speed of your business.
An efficiently documented review of chemistry data to support medical device registration in Europe. No frills, no strings attached, the data you need in the manner which it is needed.
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
For more in-depth review and data support. This offering provides comprehensive data analysis, specialist review, extended documentation, and custom support.
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
Our flagship tier, providing the needed detail to support regulatory review & product safety assessments.
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
Extractables and leachables (E&L) testing chemically characterizes a medical device to identify and quantify the substances that could reach a patient, then assesses their toxicological risk. It provides the chemical evidence that underpins an ISO 10993 biological evaluation.
Extractables are chemicals drawn from a material under exaggerated laboratory conditions (aggressive solvents and elevated temperature). Leachables are the substances that actually migrate from the device under normal, clinical-use conditions. Extractables define the worst-case set; leachables confirm real-world exposure.
ISO 10993-18 governs the chemical characterization of medical device materials — the analytical identification and quantification of extractables and leachables that feeds the toxicological risk assessment.
ISO 10993-17 defines how to establish allowable limits (tolerable intake) for identified chemical constituents and perform the toxicological risk assessment that determines whether a device's chemical exposure is safe.
Chemical characterization is typically expected for devices with prolonged or permanent patient contact, or where existing biological data alone is insufficient. A gap assessment determines the appropriate analytical depth for each device.
CHEMTOX™ PROVIDES A FULL-SERVICE END-TO-END APPROACH TO EXTRACTABLE AND LEACHABLES EVALUATION. CONTACT US TODAY TO LEARN MORE ABOUT HOW CHEMTOX™ CAN BE LEVERAGED TO SUPPORT YOUR PROJECT.
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