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.
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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.
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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.
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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.
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