In recent years, with the rapid development of medical device, there has been an increasing demand for quality and safety. The latest version of ISO 10993 standards has become a primary consideration. Among them, ISO 10993-18, the chemical characterization standard, plays a crucial role in distinguishing additives used in various processes such as raw materials, additives, process procedures, sterilization, and other potentially harmful substances. It aims to reduce the risks that may arise during clinical use.
Part 1: Identification and quantification of their chemical constituents (material composition)
Part 2: Identification the characterization of the chemical substance, e.g. mould release agents, process contaminants, sterilization residues.
Part 3: 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).
Part 4: Identification of target substances (leachables) released from medical devices by using the clinical condition.
The ISO 10993-18 chemical characterization obtained Taiwan’s first TAF ISO 17025 certification which including complete service items. LEON Biotech provides a series of complete testing consultation for extractables/leachables of medical devices.
If you are interested in the latest changes to the ISO 10993 standards, or want to know how to comply with the latest requirements of regulatory agencies such as FDA, CE, TFDA, etc., we are happy to provide you with professional consulting services. Please contact us immediately and let us ensure the safety of medical device!