ISO 5835 Standard Test for Surgical Implants, Metal Bone Screws with Hexagonal Drive Connection

Medical Tests

ISO 5835 Standard Test for Surgical Implants, Metal Bone Screws with Hexagonal Drive Connection

EUROLAB laboratory provides testing and compliance services within the scope of ISO 5835 standard. This International standard specifies dimensions and tolerances for metal bone screws with hexagonal drive connections, spherical underside of the head, and shallow and deep asymmetrical threads used in surgery.

ISO 5835 Standard Test for Surgical Implants, Metal Bone Screws with Hexagonal Drive Connection

This International standard lays down the requirements for surgical bone screws. However, it should be kept in mind that bone screws may be needed for certain applications.

It is not covered by this standard or ISO 9268. Such custom bone screws may differ slightly from standardized forms or combine Parts from these two product standards.

However, there are certain areas of the design of the screws that are critical for surgical use, such as the drive connections, the shape of the lower surface of the head, and the tooth form. These areas are areas where there is an interface with bone plates (ISO 5836 and ISO 9269) or other devices such as surgical instruments or hex wrenches (ISO 8319-1) or taps, drills and countersunk cutters. Changes to these fields are not allowed.

EUROLAB assists manufacturers with ISO 5835 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.

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