YBB 0021 Standard Test for Medical Plastic Sealing Gaskets

EUROLAB laboratory provides testing and compliance services within the scope of YBB 0021 standard. Gaskets seal the connection between two parts to prevent leakage or contamination, usually from dirt or dust.

For leaks during testing, a dye penetrating solution is applied locally to the seal edge to be tested. After a period of contact with the dye penetrant solution, the package is visually inspected for dye penetration.

In the real environment, harmful biological or particulate contaminants enter medical packages through leaks. These leaks are usually found in seals between packaging components of identical or dissimilar materials. Leaks can also be caused by a pinhole on the packaging material. The purpose of this test method is to visually observe the presence of duct defects due to dye leakage.

Medical grade gaskets for life science applications are often made of silicone and rubber. Material selection presents many challenges for medical device designers. Designers don't just need a reliable and cost-effective sealant or gasket material. They need a compound that meets regulatory requirements and potentially additional standards.

Medical device designers also need a medical device that supports precision manufacturing, especially in high-volume parts.

EUROLAB assists manufacturers with YBB 0021 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.