According to ISO 11607-1 Chapter 7. The evaluation includes determining where to start opening the package, ensuring that the sterile barrier system can be easily opened and confirming that the contents can be presented aseptically.
All packaging systems placed on the market after 2015 will require a usability assessment in accordance with ISO 11607-1 Chapter 7. This assessment will include checking the identification of where to start opening, the ease of opening the sterile barrier system and...
Medical devices can potentially be damaged by shock or vibration, resulting in a loss of functionality. It is essential that verification and validation (VER/VAL) tests are carried out to demonstrate the durability of the product under such conditions.
Certain medical devices may be sensitive to oxygen or moisture, which can affect their performance or shelf life. Assessing the product’s sensitivity to these elements is essential to maintain its integrity and functionality.
Sterilisation processes can potentially alter the mechanical properties of medical devices, which can affect their safe use. It’s important to evaluate the functionality of the device after sterilisation to ensure that it remains fit for its intended...