มอก. 2395 เล่ม 18-2565

Scope (English)

This standard 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).