Standardization News

A new ASTM International standard will provide a test method related to sacroiliac joint fusion devices. The standard (F3574) was developed by the committee on medical and surgical materials and devices (F04).

According to ASTM International member Nathan Wright, prior to this standard, sacroiliac (SI) joint fusion devices did not have standardized test methods. 

“Sacroiliac (SI) joint fusion devices are fairly common in the orthopedic field for treating SI joint pain and instability,” says Wright. “The lack of standardized testing has resulted in significant inconsistency in regulatory testing, as well as unspecified expectations from regulators for mechanically evaluating SI joint fusion devices.”

The new standard will result in consistent testing methodologies for SI joint fusion implants. “This measure will benefit orthopedic implant manufacturers, regulators and testing labs by having a defined test method for evaluation,” says Wright.

Wright notes that the standard must meet reproducibility requirements to ensure its precision. “We are seeking participating manufacturers and test labs to support these efforts through donating testing materials and/or test frame use to complete an interlaboratory study,” he says.

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