Leachables are chemical substances released from medical devices during continuous contact with the human body and functioning, or during interaction with other media used (such as blood, medicinal solutions, etc.). Leachables are categorized into known leachables (Target Leachables) identified based on relevant information, and unknown leachables identified through a research system for unknown substances.
Leachables generally include: |
Sterilization residues, process residues, monomers and additives in materials (including stabilizers, antioxidants, plasticizers, or colorants), as well as degradation products (including hydrolysis, degradation, or reaction products of the aforementioned substances during manufacturing, storage, and usage of the devices or materials). |
Basic Information Required for Known Leachables in Registration Documentation:
Chemical name, molecular formula and structure, CAS number (if available), source, usage and processing in the final medical device, purpose (when applicable), and amount added (if applicable). The physicochemical properties of the leachables, such as acidity or alkalinity, density, melting point, boiling point, solubility characteristics, and corresponding solubility, polarity features, etc., should also be provided. If the information on leachables is obtained through extraction studies, details of the extraction study conditions and steps should also be provided.
Unknown Leachables Research Service Process:
CIRS Testing provides professional leachables research and testing services. Through precise testing and rigorous analysis, we ensure the safety of your products in clinical applications, meeting both domestic and international standards.
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