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Update on ISO 11607 Revision
The AAMI/ST/WG7 committee met in Washington D.C. on November 15, 2005 to discuss the current status of the ISO 11607-01 and ISO 11607-02 standards and the proposed revision to the AAMI TIR 22 document - “Guidance for ANSI/AAMI/ISO 11607-1 and ANSI/AAMI/ISO 11607-2.”
Co-Chairmen, Nick Fotis and John Spitzley called on Mike Scholla to provide an update on the status of the ISO standard. There were some notes and comments on the Final Draft International Standards (FDIS) received in April that needed to be reviewed. Most of the substantive comments were received in September of 2004 and reviewed by the TC 198 committee earlier this year. All comments from the Member Bodies were resolved. A final 30 day open period for comments was closed on October 31st. The purpose of the final comment period was to allow members to review how comments were resolved and, if desired, to change their vote as a result of the resolution of a comment or to formally object to submission of the final draft. No new technical comments were invited during this time period.
The U.S. voted to approve both of the standards at the Enquiry stage (Draft International Standard (DIS)), and unless significant objections are raised, will vote affirmative on the FDIS’. There were no negative ballots from any of the 24 Member Bodies at this stage of voting. The approved DIS’ will be edited and translated prior to final balloting which is expected to occur in early 2006. The document can then be published and will most likely be available by the middle of 2006.
The majority of the meeting was devoted to a working session on revising the AAMI TIR 22 to coincide with the revised ISO 11607 standards. This activity was started about one year ago with the drafting of sections for providing guidance on interpretation and implementation of the provisions of the standards. Several meetings of the working committee have been held over the past year and a draft TIR has been developed. Several writing styles were used by contributors of the sections and one task of the working group is to standardize on a writing format. The sections will be re-formatted using a numbering system similar to the standards. New Task Group leaders will be Jan Gates of Guidant Corporation and Ram Singhal of the FPA. The timeline is to have the reformatted draft completed by February; review of the draft by the working committee by March, and review of the draft by the full WG 7 at the next meeting in June. |
