EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F1541 testing. This standard provides a characterization of the design and mechanical function of exoskeleton fixation devices, test methods for the characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria.
The ultimate goal is to develop a specification that defines performance criteria and methods for measuring the performance-relevant mechanical properties of ESFDs and their fixation to bone.
It is not the intent of this standard to describe the performance levels or case-specific clinical performance of devices, as there is insufficient information to predict the results of using any of these devices in individual patients for certain activities of daily living. Moreover, it is not to describe or specify specific designs for ESFDs.
This standard describes ESFDs for surgical fixation of the skeletal system. Provides basic ESFD geometric definitions, dimensions, classification, and terminology; material properties; performance definitions; test methods; and features determined to be important to the device's in-vivo performance.
This standard includes a terminology and classification supplement and five standard test methods, such as:
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
Multiple test methods are included in this standard. However, the user does not have to test using all of the methods described. Instead, the user should only select test methods that are justified and appropriate for a particular device design. This may be just a subset of the test methods described here.
EUROLAB assists manufacturers with ASTM F1541 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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