The Applied Technical Services Family of Companies (FoC) evaluates the mechanical properties of metallic bone screws in accordance with the ISO 6475 standard. Metallic bone screws hold fractured bones in the correct alignment needed to ensure that bones heal properly. Our state-of-the-art medical device testing lab evaluates the performance and mechanical properties of metallic bone screws, ensuring the screws perform as expected for specific applications.
What is ISO 6475?
The International Organization for Standardization established ISO 6475 as a resource for experts evaluating metal bone screws used in surgical operations. The standard’s primary objective is to confirm the reliability and quality of screws by determining several of the screw’s mechanical properties, including breaking torque and angle of rotation at failure. The standard offers an effective way for manufacturers to optimize their medical device’s design, improving the experience of both medical professionals and patients alike.
More About Our Medical Device Testing Lab
Our medical device testing experts evaluate medical devices in accordance with our clients’ unique needs and in compliance with established testing standards, such as ISO 6475.Our specialists have decades of collective experience and extensive training making them adept at using multiple methodologies to examine the behavior of surgical instruments, medical devices, and medical device components. In addition to our ISO 6475 services, we offer other bone screw tests, such as:
- ISO 18130 Dental Implant Screws
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F2502 Absorbable Plate and Screw Testing
The Importance of ISO Compliance
While ISO compliance may not be required, it is highly recommended because it highlights a manufacturer’s commitment to developing effective, safe, and reliable products. ISO compliance is particularly important for devices that will experience significant stress during operation. Metal bone screws are important to evaluate in conjunction with ISO procedures because the screws must display the ability to resist rotational forces while being capable of withstanding load-bearing activities.
Contact Us
To learn more about our lab’s medical device testing capabilities, please submit an online request form or contact us at +1 (888) 287-5227.
