Standard
ISO 15142-2
Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components
Specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.
Our Testing Services
When choosing a medical device testing laboratory to perform evaluations, there are four key elements to consider:
- Interaction with a senior engineer to review the intricacies of the device and to ensure the proposed testing will address corporate goals and objectives
- Accurate implementation of the testing standard(s)
- Comprehensive reporting of the materials, procedures and data to align with ASTM/ISO and USFDA reporting requirements
- Regularly scheduled and documented verification, calibration and maintenance of testing equipment
ORL does all of the above, always has, and laid the groundwork for many of today’s active standards!
