New ISO Standard for Spinal Disc Implants

A new International Organization for Standardization (ISO, Geneva, Switzerland) standard will help ensure that spinal disc prostheses meet requirements for wear resistance, since once implanted, discs need to absorb the impact from the body's daily activities for years to come.

ISO 18192-1 will promote the development of safe and resistant prostheses for patients and constitute a useful tool for the medical industry. The first part of what is intended as a multi-part standard outlines a test procedure for the relative angular movement between articulating components and specifies the pattern of the applied force, speed, and duration of testing, sample configuration and test environment. Both lumbar and cervical prostheses are addressed. The primary users of this ISO standard will be medical device manufacturers and laboratories in public and private sectors providing biomechanical testing services for medical devices.

"The value of this standard to the medical community is that it provides direction on how to evaluate the wear performance of a new class of medical devices,” said Dr. Christian Kaddick, project leader for the development of the standard. "Without standardized methods, it is impossible to compare data between laboratories. ISO 18192-1 thus removes a potential barrier, speeding and facilitating technological developments in this area.”

The new standard is titled Implants for surgery – wear of total intervertebral spinal disc prostheses, Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test requirements for comparing the wear performance of different spinal disc prostheses.


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International Organization for Standardization