The Applied Technical Services Family of Companies (FoC) evaluates the impact resistance of ceramic femoral heads used in hip joint prostheses in compliance with ISO 11491. Total hip replacement, also referred to as hip joint prosthesis, is a popular procedure that helps hundreds of thousands of Americans address their hip pain caused by injury and disease annually. Our medical device testing experts help manufacturers evaluate their hip joint prosthesis designs, verifying that they comply with internationally recognized regulations.
What is ISO 11491?
The International Organization for Standardization developed the ISO 11491 standard as a resource for experts determining the impact resistance of ceramic femoral heads designed for hip joint prostheses. The standard details methodologies that effectively evaluate a ceramic femoral head’s ability to withstand impacts. The standard is critical to manufacturers seeking to determine how their product designs respond to real-world scenarios.
About Our Medical Device Testing Lab
Our medical device testing experts use their decades of collective experience to conduct comprehensive testing that determines the strengths and weaknesses of medical devices and their components. We offer services that meet the unique needs of our clients while also providing many services that comply with notable ISO and ASTM standards, such as:
- ISO 11491
- ISO 7206-4
- ISO 7206-6
- ISO 7206-8
- ISO 7206-10
- ISO 7206-12
- ASTM F1820
Our medical device testing lab’s staff consists of educated and experienced mechanical testing experts, engineers, lab technicians, regulatory consultants, and project managers. Our entire staff recognizes the importance of customer service, so we work alongside our clients to ensure they develop safe, effective, and compliant medical devices.
The Importance of ISO Compliance
ISO medical device standards enable manufacturers to employ uniform methodologies for evaluating their product’s mechanical performance, which is crucial for ensuring that the product meets established safety and performance standards. ISO compliance also helps manufacturers gain market access, helping them sell their products to more consumers in various international markets. Consumers and medical providers also have immense trust in ISO standards, so products that comply with them are more likely to be trusted.
Contact Us
Give us a call at +1 (888) 287-5227 to learn more about our ISO 11491 testing capabilities.
