ＷＧ９ストックホルム会議（１９９６．４）議事録

Comments mede during CD voting on Annex D - Evaluation of Hemolytic Properties
of Medical Devices were reviewed and revisions were made to Annex D.  This revised
document will be resubmitted to ISO and it will be circulated as a DIS to become an 
Amendment to ISO 10993-part4.

The group then began to discuss a New Work Item, which was to consider an 
Informative Annex on Complement Activation.  After discussion, the working group
recommended that the work item on an Annex on Complement Activation be withdrawn
and that a new work item takes its place.  The New Work Item would be to begin revision
of the original ISO 10993-4 document.  The goal of the revision would be to incorporate
not only more information about complement activation, but also attempt the order blood 
compatibility parameters and also to consider the clinical significance of the various tests
during device evaluatiion.

Therefore WG9 would like to propose a resolution that TC194 change the work item
to a Complete Revision of ISO 10993-4.