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DS/ISO 10993-18:2020/Amd 1:2022
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
This document specifies a framework for the identification of biological hazards and the estimation and*control of biological risks from material constituents, using a stepwise approach to the characterization*of a medical device through:*– 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);*– the estimation 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 may 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 of standards 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.
Danish Standards [ds]