ISO 10993-18 specifies a framework for the identification and quantification of constituents of a medical device. It allows for the identification of biological hazards and the estimation and control of biological risks from material constituents. This standard is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
The framework in ISO 10993-18 uses a generally stepwise approach to chemical characterization, which can include one or more of the following:
— the identification of its materials of construction (medical device configuration),
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition),
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues),
— 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 (extractables),
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification or quantification) of degradation products. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
The international standard has been approved in Europe as EN ISO 10993-18:2020 without any modification and it supersedes EN ISO 10993-18:2009.
