ANNEX 1 to Council 51/2000 August 2000 ISO PILOT PROJECT WITH IEEE – PROPOSAL 1. Scope The IEEE Medical Information Bus Committee of the Engineering in Medicine and Biology (EMB) Society desires to submit the following six (6) IEEE projects/standards to ISO/TC 215 Health informatics for adoption: P1073.1.1.1 (Draft) Standard for Medical Device Communications - Medical Device Data Language (MDDL) - Nomenclature P1073.1.2 (Draft) Standard for Medical Device Communications - Medical Device Data Language (MDDL) - Virtual Medical Device, Generalized 1073.3.1-1994 IEEE Standard for Medical Device Communications - Transport Profile Connection Mode P.1073.3.1a (Draft) Standard for Medical Device Communications - Transport Profile Connection Mode Amendment 1 1073.4.1-1994 IEEE Standard for Medical Device Communications - Physical Layer Interface - Cable Connected 1073.4.1a (Draft) Standard for Medical Device Communications - Physical Layer Interface Cable Connected Amendment 1 2. Parallel processing IEEE is proposing to take responsibility for the development and maintenance of these standards as ISO/IEEE standards through the IEEE Committee with unrestricted participation and input via ISO member bodies and their duly appointed technical experts. Representatives of the appropriate ISO member bodies will automatically receive all ballots and related technical correspondence concerning the development of these documents into ISO/IEEE standards. Member bodies are free to copy and distribute this information to anyone for the sole purpose of gathering greater consensus on the technical content of these standards. 2.1 Approval of ISO/IEEE standards projects 2.1.1 IEEE proposes to the appropriate ISO technical committee (TC 215 Health informatics in the present case) to put these IEEE standards through a process to gain recognition as ISO/IEEE standards. The proposal will include the IEEE standard title, scope, and rationale for using this process as well as the justification of the need for an International Standard and the identification of other bodies in liaison. 2.1.2 A letter ballot will be sent by the ISO TC/SC secretariat to the members of the TC/SC requesting approval to send the action to DIS ballot. A 2/3-majority vote of the P-members of the ISO TC is required for approval. 2.1.3 If the ballot is disapproved, IEEE will have the opportunity for further review and discussion with the ISO Technical Management Board. pc/9877853 ANNEX 1 to Council 51/2000 Page 2 2.2 DIS ballot 2.2.1 If approved, a DIS ballot will be sent by the ISO Central Secretariat to all ISO member bodies. The ballot shall include a copy of the IEEE standards being considered for approval as ISO/IEEE standards. The ballot will remain open for five months. (Standards will be distributed electronically wherever possible.) 2.2.2 Votes submitted by ISO member bodies shall be explicit: approval, disapproval, or abstention. An approval vote may be accompanied by editorial or minor technical comments, but shall not be conditional on the acceptance of modifications. A disapproval vote shall contain technical reasons and should indicate specified technical modifications that will change the disapproval vote to one of approval. 2.2.2a If the DIS ballot has achieved 100% approval from the P-members of the ISO technical committee, then the standard is approved as an ISO/IEEE standard and shall proceed to the publication stage. 2.2.2b When less than 100% approval is achieved in the DIS ballot, the appropriate IEEE subcommittee will address all disapprovals in accordance with the Regulations Governing IEEE Technical Committees. Every effort shall be made by the IEEE technical committee to resolve the disapprovals. If any disapprovals are found persuasive, the IEEE standard will be revised and re-balloted to the IEEE Committee and, by the ISO Central Secretariat, to the ISO member bodies. The ballot will be open for two months. 2.3 FDIS ballot 2.3.1 If the disapprovals are found non-persuasive by the IEEE Committee and the DIS acceptance criteria have been met, IEEE will provide a report of voting and the final text of the standard to the Central Secretariat. The ISO Central Secretariat shall prepare an FDIS which will be circulated to all ISO member bodies. The ballot will be open for two months. 2.3.2 Votes submitted by ISO member bodies shall be explicit: approval, disapproval, or abstention. An approval vote may be accompanied by editorial or minor technical comments, but shall not be conditional on the acceptance of modifications. A disapproval vote shall contain technical reasons and should indicate specified technical modifications. 2.3.3 The FDIS is approved if : a) a two-thirds majority of the votes cast by the P-members of the ISO technical committee are approval and in favour and, b) not more than one-quarter of the total number of votes cast by all member bodies are disapproval. Abstentions are excluded when the votes are counted, as well as disapproval votes not accompanied by technical reasons. Technical reasons for disapproval votes are submitted to the IEEE subcommittee for consideration at the time of the next review of the standard. c) The ISO Central Secretariat shall inform IEEE and the ISO TC/SC of the outcome of the process. (Technical reasons for disapproval votes shall be appended for information only.) The ISO Central Secretariat shall submit to all national bodies a report showing the result of voting and indicate either the formal approval by national bodies to issue the standard or formal rejection of the standard. d) If the FDIS has been approved in accordance with all of the above conditions, it shall proceed to the publication stage. pc/9877853 ANNEX 1 to Council 51/2000 Page 3 e) If the FDIS is not approved in accordance with all of the above conditions, the document shall be referred back to the IEEE subcommittee concerned for reconsideration in light of the technical reasons submitted in support of the disapproval votes.] 2.4 Maintenance 2.4.1 Revisions to the ISO/IEEE standards can be proposed to the relevant IEEE committee having jurisdiction at any time by members of IEEE or the ISO TC/SC. a) Minor revisions of an ISO/IEEE standard shall be balloted by the appropriate IEEE committee and by the ISO member bodies as an FDIS for a two-month period. b) Major revisions of an ISO/IEEE standard shall be balloted by the appropriate IEEE committee and by the ISO member bodies as a DIS for a five-month period. 2.5 Periodic review 2.5.1 ISO/IEEE standards that have been published for four years since their last approval date and without pending ballot actions shall be reviewed in their entirety by the responsible IEEE subcommittee and shall be letter balloted for re-approval (confirmation), revision, or withdrawal. Such action shall be initiated within five years of the last approval date. 2.5.2 IEEE will notify the appropriate ISO TC/SC of this impending action and will request ISO’s recommendation regarding the re-approval (confirmation), revision, or withdrawal of the standard prior to the next IEEE meeting where such action will be initiated. 2.6 Logos and document designation(s) 2.6.1 Both the ISO and IEEE logos will appear on the cover pages of ISO/IEEE standards, along with copyright and trademark notices and any appropriate disclaimers in the front matter. 2.6.2 The designation(s) for the documents will be a single designation ISO/IEEE XXXX. IEEE requests that ISO explore creating a numbering format that could incorporate the wellrecognized existing number 1073 into a longer number (e.g., 11073) in order to retain marketplace identity of the standards. 2.7 Publishing 2.7.1 Publishing (English versions) 2.7.1.1 IEEE will edit, maintain, and publish the English version of the approved standards providing the ISO/CS with appropriate camera-ready copy and electronic files, including an SGML version. The ISO/CS will provide the cover information to the IEEE Standards Department in a timely manner not to exceed one month from ISO approval. The ISO Secretary-General is prepared to provide fair financial compensation to IEEE for the cost of this work and material, at a level not more than the same would cost were it to be fully done at the ISO/CS. 2.7.1.2 IEEE will publish its version in the ISO format, as is normal operating procedure. pc/9877853 ANNEX 1 to Council 51/2000 Page 4 2.7.2 Publishing (French versions) For the French versions of the ISO/IEEE standards the “business as usual” approach will be followed; i.e. AFNOR will, on request, provide the French versions as needed for parallel processing, and for the DIS and FDIS approvals. The ISO/CS will then handle editing and publication of the final French version of the standards, providing the IEEE Standards Department with copies of the cover and front matter for their records. 2.8 Copyright 2.8.1 Copyright ownership will be held jointly by ISO and IEEE, with normal exploitation rights transferable to the ISO member bodies in the ISO process when doing national adoptions. 2.8.2 When ISO and IEEE publish and distribute the ISO/IEEE documents, the copyright notice will include both ISO and IEEE. 2.8.3 Exploitation rights will be transferred by ISO and IEEE to all member bodies (the USA case being negotiated between ANSI and IEEE) who sell the original version or adopt it as a national standard; and it is agreed that neither IEEE nor ISO will insist that the other provide accounts of sales or other exploitation results. When adopting the ISO/IEEE standards as national standards, ISO member bodies will be invited to provide the ISO/IEEE numerical designation on the front cover and provide recognition to ISO/IEEE in the front matter. 2.8.4 In the USA, IEEE retains all exploitation rights. IEEE and ANSI have made appropriate business arrangements in a separate document. 2.9 Sales and distribution 2.9.1 ISO members have no geographical restrictions on their rights to sell nationally adopted versions of ISO Standards without paying royalties, and this will apply equally for ISO/IEEE standards. Further, there would be no restrictions, either for IEEE or ISO members, on presentation media (e.g. electronic media), or on the rights to distribute or sell via third parties. 2.9.2 IEEE, acting as an ANSI accredited SDO with all exploitation and distribution rights for this pilot case, may also sell the ISO/IEEE standards anywhere in the world without paying royalties to ISO or its members. 2.9.3 If translations other than into French of the published ISO/IEEE standards are made available by the member bodies, IEEE may wish, and is encouraged, to enter into agreements with the member bodies to share rights to those translations, and have the option to copublish in those other languages. pc/9877853