1. Trial Molding and Process Validation
After mold completion, a systematic trial molding process is required to verify molding process parameters, product dimensions, and appearance quality. Complete data should be recorded during medical mold trial molding, including process parameters such as temperature, pressure, and time, as well as the results of key product dimension inspections. Multiple rounds of trial molding adjustments are typically required to achieve stable production.
2. Lifespan Testing and Durability Validation
Medical molds require simulated production lifespan testing to verify their performance stability within the designed production volume. Testing should include continuous production testing, intermittent production testing, and other operating conditions to assess mold wear and maintenance cycles. For high-value molds, the installation of sensors to monitor the status of key components in real time may be considered.
3. Product Compliance Testing
Samples produced from the mold must pass relevant medical standard tests, including dimensional accuracy testing, functional testing, material biocompatibility testing (if applicable), and sterilization adaptability testing. Only when the samples fully comply with medical regulatory requirements can the mold be put into formal production.
