US and UK-based Lucideon, the materials technology company, and Hong Kong Standards and Testing Centre (STC), the testing, inspection and certification organization based in Hong Kong and China, are offering orthopaedic implant manufacturers in the Asia region, and their supply chain, a series of seminars on wear testing and medical devices testing.
The seminars will run on 24 May at STC’s new facility in Dongguan and on 26 May in Shanghai.
Topics covered in the seminars will include ISO and ASTM standards for orthopaedic implants testing, mechanics of AMTI and ProSIM multi-station simulators for upper and lower limb joints, and regulatory requirements for FDA approvals. Adverse testing, such as third-body abrasion, impingement, micro-separation and aging will also be included, as will wear debris analysis, ion release testing and surface characterization.
The seminars form part of Lucideon’s and STC’s collaboration that offers testing and analysis services to the medical device sector and allows Asian orthopaedic implant manufacturers who export to the EU or USA to have their products tested by an accredited European or US test house.
Steve Newman, Senior Product Manager at Lucideon, said:
The seminars will be a great opportunity for Asian implant manufacturers to learn more about the regulatory requirements and the standards that orthopaedic implants need to be tested to, in order to export overseas."
“Dr Qianqian Wang, a renowned expert in wear testing and head of our facilities in the UK, will be running the seminars. In addition to knee and hip implants, he will also cover spine, ankle and shoulder joints and talk about ancillary services to wear and fatigue testing, such as debris and wear pattern analysis.”
Anne Chuah, General Manager of the Chemical, Food & Pharmaceutical Products Division at STC, said: “This will be a valuable opportunity for us to collaborate with LUCIDEON to hold a seminar introducing orthopaedic implants testing. Through case sharing, I believe the audience will understand the challenges they are going to face when exporting orthopaedic medical device overseas and how to tackle these difficulties.
"During the seminar, STC will also introduce our new facilities of biocompatibility testing which is mandatory for all medical devices. Don’t miss the chance! Come and join this event.”
Lucideon has ISO/IEC 17025:2005 accreditation for the wear testing of total hip and knee replacements. The accreditation encompasses ISO 14242-1 and ISO 14242-2 standards, awarded by UKAS (United Kingdom Accreditation Service), and ISO 14243 standards, awarded by L-A-B (Laboratory Accreditation Bureau). In addition to wear testing, Lucideon also offers impingement and fatigue testing and debris analysis.
To sign up for the seminars visit www.lucideon.com/china-seminars.