ISO Technical Committee 194 Biological Evaluation Of Medical Devices, May 2000

ISO Technical Committee 194 is responsible for the standardisation of approach and test methods in the evaluation of medical devices and materials for biological safety; and administers the ISO 10993 Standard, which currently has 18 parts, of which 16 are published. In May 2000, 13 of the 15 working groups comprising the Committee (a total of 70 delegates from 13 countries) met in Japan to discuss technical and editorial issues. Doctors Shirley Bolis and Arthur Brandwood attended as TGA's delegates for Standards Australia.

In response to a questionnaire distributed prior to the Committee's meeting, several users of ISO 10993 had expressed concerns about inconsistencies of interpretation of the Standard by regulatory agencies. To address such concerns the meeting resolved that an 'informative annex' should be included in the Standard and that the Committee should investigate mechanisms through which it can play a greater role in the global harmonisation of regulatory requirements for the biological assessment of medical devices.

The need to improve the interpretation, consistency and relevance of the ISO 10993 series was a recurring theme throughout the meeting, and draft documents dealing with these issues will be circulated to member Standards Organisations for their approval within the next nine months.