Framework
ISOISO 10993-18:2020
ISO 10993-18:2020 specifies a framework for the chemical characterization of medical device materials and the identification and quantification of chemical substances that may be released from medical devices during clinical use. It guides manufacturers in analyzing extractable and leachable compounds as part of the overall biological evaluation process.
Overview
Background
Published by the International Organization for Standardization (ISO) as part of the ISO 10993 biological evaluation series, the 2020 edition of this standard expanded the scope of chemical characterization to include a more comprehensive material analysis approach. It works in conjunction with ISO 10993-1 for biological evaluation planning and ISO 10993-17 for toxicological risk assessment.
Applicability
This standard applies to manufacturers of medical devices that require chemical characterization as part of their biological evaluation. It covers the identification and quantification of extractable and leachable substances, material composition analysis, and chemical characterization of processing residues. It is relevant to all device categories but particularly important for implantable devices and devices with prolonged body contact.