The Applied Technical Family of Companies (FoC) evaluates the mechanical endurance of tibial trays designed for total knee-joint prostheses in compliance with ISO 14879-1. Total knee-joint prosthesis, also known as total knee replacement, is a complex and increasingly common medical procedure that repairs damaged knees. Patients considering total knee replacements are seeking to relieve their knee pain while retaining, if not improving their knee’s mobility. Like any medical implant, a total knee replacement’s path to a patient is filled with numerous tests, designs, regulations, and evaluations. Fortunately, our medical testing team is dedicated to delivering solutions to our clients that help them ensure that their devices earn access to numerous markets.
What is ISO 14879-1?
The International Organization for Standardization published the ISO 14879-1 standard as a guideline and resource for experts conducting mechanical endurance tests on tibial trays. The standard applies to tibial trays covering both the lateral and medial plateau of the tibia. The standards is an important resource for manufacturers seeking to compare the fatigue properties of various tibial tray designs.
About Our Medical Device Testing Lab
Our ISO/IEC 17025 accredited lab performs a wide range of tests on medical devices. We offer tests by many ISO and ASTM testing standards, supporting our clients as they prepare their products for FDA approval. We keep an open line of communication throughout our service process, helping us ensure that we’re meeting the specific requirements and demands of our customers’ projects. Upon completion of our services, our clients will have an improved understanding of their product’s strengths, weaknesses, and overall performance. In addition to our ISO 14879-1 compliant services, we also offer several other knee replacement-related tests, including:
- ASTM F1800
- ASTM F2722
- ASTM F2723
- ASTM F2724
- ASTM F3210
Why is Tibial Tray Endurance Important?
Tibial trays are incredibly important to the design of total knee replacements. They provide stability and durability for the implant, enabling it to endure the repetitive forces needed to mimic the functionality of the human knee. The ISO 14879-1 standard is an effective way for manufacturers to qualify an implant design while confirming their ability to remain safe and effective for the end user.
Contact Us
Call +1 (888) 287-5227 or submit a web request form to speak with an ATS representative about our ISO-compliant medical device testing services.
