What should be considered in the heat treatment process of additive manufacturing—selective laser melting metallic materials for removable restorations?
It is necessary to clarify method and parameters of heat treatment of the product, evaluating and verifying the suitability of the heat treatment method. The basis for determining the heat treatment parameters (including heating time, holding temperature, holding time, etc.) and the acceptability criteria of the results after heat treatment also need to be clarified.
What tests are required to add sterilization methods to the registration of orthopedic and oral implants?
To increase the sterilization method by changing the registration of permission items, it is necessary to submit sterilization verification data and carry out sterility performance test.
In case of any other performance changes caused by the addition of sterilization methods, the test shall be conducted. For example, if the sterilization method of ethylene oxide is added, the sterility test item and residual amount of ethylene oxide shall be added.
