ISO 5838-1 Implants for Surgery, Metallic Skeleton Pins and Wires, Part 1: General Requirements Test Standard

Medical Tests

ISO 5838-1 Implants for Surgery, Metallic Skeleton Pins and Wires, Part 1: General Requirements Test Standard

EUROLAB laboratory provides testing and compliance services within the scope of ISO 5838-1 standard. This part of ISO 5838 specifies general requirements for metallic skeleton pins and wires for use in bone surgery, excluding wires for binding and bending.

ISO 5838-1 Implants for Surgery, Metallic Skeleton Pins and Wires, Part 1: General Requirements Test Standard

Frame pins and wires will be manufactured by cold drawing or cold working process. Resources are not allowed. If local heating is required for reshaping points made of stainless steel, this is permissible only if it can be shown that the entire end product meets the test for intergranular corrosion according to ISO 3651-2.

The exterior finish shall be free from burs, scratches and other defects visible to the naked eye. The products will be properly treated to ensure surface passivation.

The 14630 requirements of ISO 11.3 apply and should include the following details where relevant:

  • Name of the product;
  • characteristic dimensions;
  • Material properties;
  • Dimensional characteristics of the appropriate drill bit.

ISO 14630, 11.5 requirements apply and should include the following details when dimensions allow:

  • Manufacturer's name or trademark;
  • batch code;

EUROLAB assists manufacturers with ISO 5838-1 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.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

WhatsApp