As chair of the task force, Dr. Konosu presented the revision 1 of document GTR9-1-03 containing the Terms of Reference for the TF-RUCC. He also presented document TF-RUCC-K-04-Rev.1 regarding the derivation of certification corridors and on the future action plan of the TF. He finalized that the group would like to finish its work by end of March 2012 in time for the 2nd meeting of the informal group.

Mr. Hohmann mentioned that the time schedule seems very tough. Mr. Been replied that it is tough but not impossible to achieve and that Humanetics would need the support of this group, specifically regarding the availability of impactors and maybe also regarding test capacity. Currently, five prototype legforms and 22 serial production legforms exist; additional 12 legforms currently are ordered but not yet delivered to the customers. Mr. Hohmann stressed that, however, Humanetics first need to provide some impactors with an identical build level to produce new data and to assure that the data are comparable. With these data, discussion on the certification corridors can be restarted but keeping in mind that industry would refuse the corridors being widened up. Dr. Ries underlined again that from the OEM’s point of view the corridors need to be as tight as possible but that shifting the corridors could be acceptable. The chair of the task force promised that the comments above will be considered accordingly.

Mr. Been replied that Humanetics first needs an agreement that the corridors can be redefined. With the latest modifications to the impactor it is impossible to meet the certification corridors and that data shown by Humanetics from different tests underline this. He believes that different labs should provide their data from which new corridors could be derived. The chair of the informal group added that the corridors established by the TEG should serve as starting point for further analysis.

Mr. Zander added that the very first step needs to be tests being carried out in one experienced test lab with a limited number of legforms (later on it was clarified that preferably the legforms should be serial production legforms with bone core material from different batches, as this will also occur in the future) to assure repeatability and reproducibility of the test results but excluding lab to lab variability. Starting form this point, involvement of further labs etc. can go on. Dr. Ries added that the production process of the FlexPLI must guarantee that impactors which will be sold in future will behave like those ones on which the possible new corridors will be derived from. Mr. Been replied that

Humanetics will do their very best to do so but that sometimes changes are necessary due to circumstances that cannot be controlled by Humanetics, e.g. material availability. The chair added that this of course can happen. However, it needs to be well documented and then reported to a forum like this group. Therefore detailed information and documentation on the build levels of the impactors is a prerequisite. The respective forum then may decide to e.g. revise test procedures, corridors etc. Mr. Zander underlined the link of the different issues like repeatability, impactor output and possible shift of certification corridors. A changed performance would not only mean a possible shift of certification corridors but also a possible modification of the impactor threshold values. Mr. Hohmann requested that all changes to the legform need to be well documented. After some discussion on this Mr. Been stated to bring back all this information to his company’s quality assurance group and that he will report on this.

Mr. Knotz mentioned that the informal group should also discuss the speed measurement for the FlexPLI: Currently, there is no procedure foreseen and this is also a potential issue.

The chair wondered whether the PADI or the users’ manual should cover such details. Humanetics will check if this can be incorporated.

After some discussion on all the details mentioned above it was agreed again that the task force will consider the discussion in this group in their future work.