ISO 10993-18-2020 医学装置的生物学评估--第18部份: 化学药品材料的描述 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

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.
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).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.nd edition 2020-01 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process évaluation biologique des dispositifs médicaux — Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque Reference number ISO 10993-18:2020(E) ？ ISO 2020 ISO 10993-18:2020