SIST EN ISO 10993-18:2020 PDF

Overview - ISO 10993-18:2020 (SIST EN ISO 10993-18:2020)

ISO 10993-18:2020 defines a structured framework for the chemical characterization of medical device materials as part of a biological evaluation and risk management process. The standard guides the identification and, where needed, quantification of constituents in a device or its materials to identify biological hazards and estimate/control chemical risks. It applies to devices with direct or indirect body contact and is intended for material suppliers, device manufacturers and testing laboratories.

Key topics and technical requirements

• Stepwise chemical characterization: a generally stepwise approach that can include one or more activities such as:
  • identification of the materials of construction (device configuration);
  • characterization of material composition by identifying and quantifying chemical constituents;
  • detection of manufacturing-introduced substances (e.g., mould release agents, process contaminants, sterilization residues);
  • estimation of potential chemical release using laboratory extractables testing (simulated extraction conditions);
  • measurement of chemicals released under clinical-use conditions (leachables).
• Degradation products: the standard can be used to identify/quantify degradation products (other aspects of degradation assessment are covered in ISO 10993-9, -13, -14 and -15).
• Risk management linkage: chemical data are used within a risk management process to inform biological hazard identification, toxicological risk assessment and biocompatibility evaluations.
• Scope limitations: physical specifications, particle/wear debris, packaging contaminants during transport/storage and ADME are outside this standard’s coverage.

Practical applications - who uses ISO 10993-18 and why

• Manufacturers and suppliers use ISO 10993-18 to:
  • prepare chemical characterization dossiers supporting biocompatibility and regulatory submissions (e.g., EU MDR);
  • set or confirm chemical specifications for incoming materials and finished devices;
  • prioritize biological testing based on identified chemical hazards.
• Test laboratories use it to design extractables/leachables testing strategies and analytical workflows.
• Regulatory and quality teams rely on the standard to demonstrate a robust link between material chemistry, biological evaluation, and risk management per ISO 14971.

Related standards and regulatory context

• ISO 10993 series (notably ISO 10993-1, -9, -13, -14, -15, -17) - for overall biological evaluation and related test methods.
• ISO 14971 - risk management process for medical devices.
• Alignment with Regulation (EU) 2017/745 (MDR): when cited in the Official Journal, compliance with this standard can support presumption of conformity for relevant General Safety and Performance Requirements.

ISO 10993-18 is essential for anyone managing chemical safety, extractables/leachables programs, or biocompatibility risk assessments for medical devices.