Ceram Stresses Importance of Ceramic Surgical Implant Testing to Ensure Long Term Performance
Ceram now offers a full suite of testing for Yttria-Stabilised Zirconia (YSZ), destined for surgical implants, as defined in ISO 13356 standards.
These standards specify the characteristics of, and corresponding test methods for, YSZ and were recently updated in 2008 to provide clinicians with even greater confidence in the resilience of these materials for surgical implants, including restorative and prosthetic dentistry and hip- and knee-joint replacements.
There is a growing need for longer lasting YSZ ceramic implants as a result of the ageing population combined with the trend towards younger hip implant patients who tend to opt for ceramic-on-ceramic implants over other materials. Lifetimes of 30 years or more are the goal. It is important that sufficient research is done to demonstrate that these implants meet durability needs for longer term use.
“Research into maximizing micro-structure homogeneity in sintered ceramic implants is important as there is no long term data on the performance of ceramic hip and other implants over time. As revisionary surgery can add a further 70 to 100% to the cost of the original operation, there is a need to produce implants that have certified durability,” commented Dr Phil Jackson, Business Development Manager, Medical and Healthcare, at Ceram. “I believe that the use of nanotechnology and novel shaping techniques will ultimately deliver the defect-free micro-structures needed to further retard hydrothermal ageing of YSZ. This will enhance the lifetime and reliability of implants – important factors when implants need to last longer to match increasing human longevity.”
Ceram is currently carrying out independent and collaborative research that addresses the potential barriers to successfully using nano-YSZ powders, the preferred powder of choice, in the various stages of ceramic processing, focusing on:
- Granulation of suspensions with very high solids content to minimise defects arising from pressing irregular-shaped granulates.
- Investigations on the impact of micro-wave assisted firing on the nano-structure of ceramic implants in the sintering process, to attempt to minimise loss of the desired micro-structure.
- Determining the optimum level of yttria needed to stabilise the desired tetragonal phase of YSZ ceramic implants.
Further information on recent and on-going research into ceramic processing that can help ensure the requirements of the ISO 13356 standard for implants are met and exceeded can be found in a white paper published by Ceram. Providing valuable information for manufacturers, suppliers and distributors of ceramic medical implants, or components of medical implants that contain ceramic parts, the paper also discusses how reliable performance of ceramic components in medical applications can be assessed and ensured, and outlines the tests involved. The white paper is available as a free download by filling in the form on this page.
Ceram has over 50 years' experience with ceramics and is an authority on ceramic testing. From its fully independent ISO 17025:2005 accredited laboratory, Ceram provides a full testing and analysis service for advanced ceramics and for the ISO 13356 tests. Ceram is an active participant with European and international committees to develop standardised test methods, which in conjunction with the resource of their comprehensive information centre ensures they are fully up to date with the correct testing methods.