ISO 10993-18:2020
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
- Standard No.
- ISO 10993-18:2020
- Release Date
- 2020
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 10993-18:2020/Amd 1:2022
- Latest
- ISO 10993-18:2020/Amd 1:2022
- Scope
- This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the 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 and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
ISO 10993-18:2020 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 14971 Medical devices - Application of risk management to medical devices
ISO 10993-18:2020 history
- 2022 ISO 10993-18:2020/Amd 1:2022 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
- 2020 ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
- 2005 ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
