The Applied Technical Services Family of Companies (FoC) evaluates modular femoral heads in accordance with the ISO 7206-10 testing standard.
What is ISO 7206-10?
The International Organization for Standardization developed the ISO 7206-10 standard as an outline for experts determining a modular femoral head’s resistance to static loads. The standard’s objective is to uncover and quantify the static loads needed to cause the failure of a modular head system. The standard determines the specimen’s disassembly and fracture load. The testing processes simulate real-world conditions, giving manufacturers an accurate depiction of how their products will perform when used regularly by patients. Compliance with the standard highlights a manufacturer’s commitment to developing compliant, safe, and effective products that have a proven track record of performing to internationally adopted standards.
More About Our Medical Device Testing Services
Our lab offers much-needed support to manufacturers seeking to evaluate their products while ensuring their compliance with relevant regulatory requirements. Our A2LA accreditation showcases our commitment to maintaining quality and transparency and the experience of our leaders and experts ensures that our processes are thorough and detailed. We recognize the immense impact that medical devices have on millions of people worldwide, so we have invested in state-of-the-art equipment that is adept at simulating real-world conditions that medical device end users face. This enables us to support the design and development of many types of medical devices, including:
- Hip implants
- Dental implants
- Knee implants
- Joint replacement
- Cranial implants
The Importance of Compliance with ISO Standards
ISO standards ensure the quality, safety, and effectiveness of medical devices. Many regulatory entities including the FDA require that manufacturers comply with standards developed by the ISO and similar institutions like ASTM. Compliance with ISO standards is an effective way to do the following:
- Highlight your company’s commitment to safety
- Address potential design flaws and hazards
- Ensure adequate levels of quality control
- Support improved manufacturing processes
- Increase consumer trust in a product
Contact Us
To learn more about our medical device testing lab and other departments, please submit a web request form or call +1 (888) 287-5227 for additional information.
