Chemical characterisation of medical device materials in a risk management process as per ISO 10993-18
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Date
2025-10-18
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SCTIMST
Abstract
The demand for medical devices in India is steadily increasing. The National Medical Device Policy 2023 was introduced with the goal of capturing a 10-12% share of the global medical device market within the next 25 years. Achieving this objective requires strengthening medical device development and testing capabilities. Each medical device must undergo rigorous biological evaluations in accordance with international standards to ensure patient safety and prevent health risks.
ISO 10993-18 provides a framework for the chemical characterization of medical device materials, crucial for toxicological risk assessment. Chemical characterization involves several steps, including the identification of material components, analysis of their composition, and estimation of extractable, leachable, and degradation products released from the device under ambient or accelerated conditions. This process also helps establish the equivalence of a new material or device with existing ones. Combining chemical characterization with toxicological risk assessment enables the screening of potential materials or devices for clinical use and ensures the biological safety of new or reprocessed medical devices. The presentation will focus on the step-by-step methodology for chemical characterization of medical devices according to ISO 10993-18.