ISO-10993-18 Chemical Characterization

Chemical characterization involves the identification of a material and the identification and quantification of its chemical constituents as part of an assessment of the overall biological safety of a medical device. It involves a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health-based risk assessment, to determine the equivalence of a proposed material to another material or another final device/prototype, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.

Have you tried our Test Navigator Tool? Try it now

Why Chemical Characterization Testing is Performed

Chemical characterization (Extractables and Leachables Testing) is conducted for several reasons:

1. To ensure patient safety by identifying potentially harmful substances that could migrate from the device during use.
2. To comply with regulatory requirements and standards.
3. To assess the quality and consistency of materials used in device manufacturing.
4. To support the selection of appropriate materials for device design.

Steps in Conducting Chemical Characterization Testing

1. Study design: Develop a testing plan based on the device’s intended use, materials, and risk assessment
2. Sample preparation: Subject the device or components to appropriate extraction conditions
3. Chemical analysis: Use various analytical techniques to identify and quantify extractable substances
4. Data interpretation: Evaluate the results and compare them to established safety thresholds.
5. Toxicological risk assessment: Assess the potential biological impact of identified substances.
6. Reporting: Compile findings and conclusions for regulatory submission or internal decision-making.

Applicable Standards, Guidance, and Regulations

When conducting this testing for medical devices, the following standards and guidelines should be followed:

• ISO 10993 series, particularly ISO 10993-18 for chemical characterization
• FDA guidance documents on biocompatibility testing and chemical characterization
• European Medical Device Regulation (EU MDR)
• USP chapters related to extractables and leachables (e.g., <1663>, <1664>, <1665>)
• Product Quality Research Institute (PQRI) guidelines
• International Conference on Harmonisation (ICH) guidelines for pharmaceutical products

Related Services You May Be Interested In

• Extractables and Leachables Testing
• Biocompatibility Testing Services