ISO 10993 discusses the biological evaluation of medical devices. ISO 10993‑18 outlines the chemical characterization of medical device materials within a risk management process. ISO 10993‑18 specifies a framework for the identification and quantification of constituents of a medical device, allowing the identification of biological hazards. ISO 10993‑18 estimates and controls the biological risks from material constituents, using a generally stepwise approach to the chemical characterization.
Chemical characterization includes the identification of its materials of construction, the characterization of the materials of construction via the identification and quantification of their chemical constituents, the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions, and the measurement of chemical substances released from a medical device under its clinical conditions of use.
ISO 10993‑18 on chemical characterization of medical device materials is useful for:
Chemical characterization, biological evaluation, and risk assessment process is most efficient and effective if it is based on the minimum amount of acceptable and necessary chemical information that can establish that a medical device presents an acceptable health risk.
ISO 10993‑18 guideline helps you with assessing material, hypothetical worst-case, analytical evaluation threshold, chemical release, and exiting the chemical characterization process. ISO 10993‑18 provides a material composition, extractables, leachable, structural composition or configuration, and analytical methods. This helps in the reliable assessment of chemical characterization of medical device materials.
BS EN ISO 10993‑18:2020 supersedes ISO 10993‑18:2005, which has been withdrawn. BS EN ISO 10993‑18:2020 has some technical changes with respect to ISO 10993‑18:2005. These include:
EN ISO 10993-18:2020
ISO 10993-18:2020