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ISO 10993-18:2020

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ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

standard by International Organization for Standardization, 01/01/2020

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ISO 10993-18:2018 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.

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Edition: 2nd Published: 01/01/2020 Number of Pages: 74 File Size: 1 file , 4.2 MB