New ISO standard for spinal disc implants will help reduce suffering of back pain patients

01-31-2008: A new ISO standard will help ensure that spinal disc prostheses meet requirements for wear resistance, particularly important as once implanted these will need to absorb the impact from the body's daily activities for years to come.

Medical surgeryISO 18192-1:2008, 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 provides requirements for comparing the wear performance of different spinal disc prostheses.

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 estimated worldwide market size for artificial disc prostheses will exceed USD 1 billion by the year 2010.

Intervertebral spinal discs act as cushions that absorb shocks to a person's back resulting from their daily activities. These discs can be damaged through age or following an accident and put pressure on spinal nerves, which can be very painful. Most people will experience back ache due to damaged intervertebral discs at some stage in their lifetime. Unfortunately, the most common methods to deal with neck and back pain fail in a significant number of patients.

ISO 18192-1 will allow the uniform testing and comparison of this relatively new technology ensuring the performance of different prosthesis. Its consensus based methodology will provide a reliable and concise reference. Within the medical industry, this standard will provide transparency, improve communication and level the playing field for competing suppliers. Surgeons will be able to rely on soundly based comparative information for different devices.