What is ISO 10993‑18 about?
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.
Who is ISO 10993‑18 for?
ISO 10993‑18 on chemical characterization of medical device materials is useful for:
- Manufacturers and suppliers of medical devices
- Medical laboratories
- Regulatory authorities
- Notified bodies
Why should you use ISO 10993‑18?
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.
What’s changed since the last update?
BS EN ISO 10993‑18:2020 supersedes ISO 10993‑18:2005, which has been withdrawn.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:
- Greater integration and harmonization with ISO 10993-1, ISO 10993-12, and ISO 10993-17
- A revised and expanded chemical characterization process flowchart
- A strengthened explanation that analytical testing is not necessarily required
- Added discussion of considerations related to analytical method qualification
- Clarified testing approaches unique to chemical characterization (i.e., digestion and dissolution for hazard identification)