Standar ISO 10985

Test Materials: ISO 10985 specifies that the test materials for aluminum-plastics combination caps used in infusion bottles and injection vials must include aluminum foil, plastic materials, and any relevant sealing components. These materials are assessed for their suitability in ensuring effective sealing, stability, and compatibility with the packaging’s intended use.
Test Process: The test process outlined in ISO 10985 involves several procedures, including the measurement of mechanical properties, sealing performance, and chemical resistance. The caps are subjected to simulated conditions such as thermal cycling, mechanical stress, and exposure to fluids to evaluate their durability and sealing integrity.
Test Result Interpretation: The test results are interpreted based on the performance of the cap in relation to criteria such as leak resistance, ease of application, and stability under stress. Failures in sealing or structural integrity indicate that the cap does not meet the required standards for safe and reliable use in medical applications.