Leading experts from ISO, along with Senior regulators will meet in Guangzhou in September to discuss evolving approaches to biocompatibility evaluation. In a special workshop at the China International Medical Device Regulatory Forum, the experts will discuss the planned changes in ISO 10993 standards, including greater reliance on chemical characterisation, reduction in animal models and a strengthened risk management framework.
This is the second year CIMDR has held a Biocompatibility workshop. Last year the expert group set out the risk management model for biocompatibility evaluation – and focussed on the interplay between ISO 10993 and ISO 14971. This time around the focus will be on practical implementation. The workshop will feature presentations from several leading experts from ISO, as well as senior representatives from CFDA and Chinese type testing labs. The workshop will cover the practicalities of biological evaluation, as well as the ways in which the ISO 10993 family of standards is being updated and modernised.
It’s a particularly busy time for ISO Technical Committee 194 – the body responsible for ISO 10993. Almost all of the key parts of the standard are undergoing major revision. The group is working on changes to chemical characterisation (Part 18), allowable limits for leachables (Part 17) and the overall evaluation framework (ISO 10993-1). In addition there is substantial work in updating the individual test standards to account for new technologies and knowledge including new in vitro tests to replace animal models.
With the sensitivities available from modern analytical chemistry, a common theme is a potential shift towards greater chemical characterisation and less reliance on biological tests – which are necessarily slower and more costly and possibly less sensitive.
I’ll be co-chairing the workshop along with Ms Shi Xinli – Senior reviewer from CFDA’s Centre for Devices Evaluation. Promises to be a fascinating and intriguing event. Join us in Guangzhou September 21-24. Visit www.cimdr.com for more information and registration details.
Need support in biological evaluation? Contact us for a confidential discussion on how we can assist you navigate the technical requirements of ISO 10993 and apply them in multiple markets.