Operating Procedures

for the

IEEE Engineering in Medicine and Biology Society (EMBS)

Standards Committee

Introduction

These Operating Procedures outline the orderly transaction of business of this committee. In those operations affecting the development of standards, openness and due process must apply; therefore any person with a direct and material interest in the development of a standard will be allowed to participate by expressing a position and its basis; by having that position considered by the committee, and by appealing when adversely affected.

Although these procedures will govern the operations of this committee, provisions of the following documents take precedence in the order given below:

IEEE EMBS Standards Committee Scope

The IEEE EMBS Standards Committee (the Committee) will encourage, facilitate, promote,and coordinate standards development activities that are useful and appropriate in the fields of medicine and biology. The scope and activities of the Committee shall conform to the operations and principles of the IEEE and the IEEE Engineering in Medicine and Biology Society.

The IEEE EMBS Standards Committee (the Committee) will encourage, facilitate, promote and coordinate standards development activities that are useful to engineers in the fields of medicine and biology within the scope of the IEEE EMBS.

1.0 Organization of the Committee

The Committee shall consist of a Chair, Vice-chair, Secretary and its members. When staff resources permit, the Committee shall be supported by a Standards Staff Liaison.

2.0 Responsibilities of the Committee

The Committee shall be responsible for the following:
(1) Developing proposed IEEE standards within the scope of the Committee
(2) Voting on approval of proposed IEEE standards within its scope
(3) Maintaining the standards developed by the Committee in accordance with the IEEE Standards Operations Manual
(4) Responding to requests for interpretations of the standards developed by the Committee
(5) Acting on other matters requiring Committee effort as provided in these procedures
(6) Cooperating with other appropriate standards development organizations
(7) Reporting annually to the Engineering in Medicine and Biology Society and to the IEEE Standards Board

3.0 Officers

There shall be a Chair, a Vice-chair and a Secretary appointed or elected in accordance with the procedures of the IEEE Engineering in Medicine and Biology Society. They may serve consecutive terms.

3.2 The Chair shall organize the committee, oversee the committee's compliance with these procedures and, submit proposed standards approved by the Committee, with supporting documentation, for IEEE Standards Board review and approval as IEEE standards.

3.3 The Vice-chair shall carry out the Chair's duties if the Chair is temporarily unable to do so.

3.4 The Secretary shall record and have published minutes of each meeting.

4.0 Membership

4.1 Membership in the Committee shall be in accordance with the procedures of IEEE EMBS. A request for active voting membership shall be addressed to the Chair, indicating the applicant's direct and material interest in the Committee's work, qualifications, and willingness to participate actively. Active Committee members must also be IEEE Standards Association members in good standing.

4.2 Review of Membership

The Chair shall review the membership list annually. Members are expected to fulfill the obligations of active participation. When a member is found in habitual default of these obligations, the Chair shall consider the matter for appropriate action, which may include termination of membership, designated as "inactive" for puposes of determing a quorum.

4.3 Interest Categories

All appropriate interests that might be directly and materially affected by the standards activity of the Committee shall have the opportunity for fair and equitable participation without dominance by a single interest. Members shall propose their own interest categories as appropriate. The interest categories shall be established or revised by a vote of the Committee.

4.4 Membership Roster

The Secretary shall maintain a current and accurate Committee roster of active members and shall distribute it to the members at least annually and upon request. All changes to the roster shall be forwarded to the Chair immediately. The roster shall include the following:
(1) Title of the Committee and its designation.
(2) Scope of the Committee.
(3) Officers - Chair, Vice-chair, Secretary.
(4) Members: for all, list name, address, society(ies) and business affiliations; for society or organizational Designated Representatives (DR) and alternates (DRA), list as DR or DRA and the society or organization (as applicable) together with organization address
(5) Interest Category of each member
(6) Tally of interest categories - total of voting members and subtotals for each interest category
(7) For each subgroup - title, chair, and names and addresses of all members

5.0 Subgroups Created by the Committee

When one or more subgroups (subcommittees, working groups, technical subcommittees, writing groups, etc.) are formed to expedite the work of the Committee, their formation (and later disbanding) requires approval by a majority vote of the Committee and the approval of the IEEE Standards Board. The Chair of a subgroup shall be appointed by the Chair of the Committee. The scope and duties delegated to the subgroup shall be approved at the time it is formed, and subsequent changes in scope or duties shall also require approval. The scope, duties, and membership of all subgroups shall be reviewed by the Committee annually. The charge to the subgroup shall clearly state which of the following is appropriate:
(1) The subgroup is responsible for the definitive content of one or more standards and for responding to views and objections thereon. Such subgroups shall maintain a membership roster and shall comply with the provisions for voting on the standard(s).
(2) The subgroup is responsible for assisting the Committee (for example, drafting all or a portion of a standard, drafting responses to comments, drafting positions on international standards, or other purely advisory functions).

5.1 Balloting Group

For approval of Standards the sponsor shall form a Balloting Group. This Group may be the Committee, provided it meets the criteria for composition given in Clause 5.4.1 of the IEEE Standards Operations Manual. Alternatively, the Committee may form and delegate the balloting to a subordinate committee in accordance with Clause 5.5.2 of the IEEE Standards Operations Manual.

6.0 Meetings

Committee meetings shall be held, as decided by the Committee, the Chair, or by petition of five or more members, to conduct business, such as making assignments, receiving reports of work, considering draft standards, resolving differences among subgroups, and considering views and objections from any source. A thirty-day notice including an agenda, shall be mailed to all members, observers and experts. Meetings of subgroups may be held as decided upon by the members or chair of the subgroup.

6.1 Quorum

There shall be a quorum for conducting business at a meeting. If a quorum is not present, actions may be taken subject to confirmation by letter ballot, as detailed in Section 7.2 . The designated quorum should protect against totally unrepresentative action in the name of the committee. See Robert's Rules of Order (Revised).

7.0 Vote

Each voting Committee member shall vote one of the following positions:

(1) Affirmative;
(2) Negative, with reasons (the reasons for a negative vote shall be given and should include specific wording or actions that would resolve the objection);
(3) Abstain, with reasons.

7.2 Voting By Mail or Electronic Mail Ballot

The Committee shall be allowed to conduct Committee business between meetings at the discretion of the Chair by a thirty-day mail ballot.

7.3 Actions Requiring Approval by a Majority

The following actions require approval by a majority of the membership of the Committee either at a meeting or by mail ballot:

(1) Formation of a subgroup, including its procedures, scope, and duties
(2) Disbanding subgroups
(3) Approval of minutes

7.4 Actions Requiring Approval by Two-Thirds of Those Voting

The following actions require a letter ballot or an equivalent formal recorded vote with approval by at least a majority of the membership and at least two-thirds of those voting, excluding abstentions:

(1) Adoption of Committee procedures, interest categories, or revisions thereof
(2) Approval of change of the Committee scope
(3) Approval of termination of the Committee

7.5 Actions Requiring Approval by Seventy-five Percent of Those Voting

Approval of a new standard or reaffirmation of an existing standard shall require a seventy-five percent return of ballot and approval by 75% of those voting affirmative or negative. All negatives must be recorded and an attempt made to resolve them.

8.0 Communications

8.1 Formal Internal Communication

If correspondence between subcommittees or between working groups of different subcommittees involves issues or decisions (that is, non routine matters) affecting other subcommittees, copies shall be sent to all affected subcommittee chairs, the Secretary, and the Committee officers.

8.2 External Communication

Inquiries relating to the Committee should be directed to the Chair, and members should so inform individuals who raise such questions. All replies to inquiries shall be made through the Chair.

9.0 Interpretations

Written inquiries requesting interpretation of the Committee's IEEE approved standards shall be responded to by the Interpretations Subcommittee. Revisions to the standard resulting from requests for interpretations shall be processed in accordance with these procedures. Copies of all requests for interpretations and subsequent responses should be forwarded to the Secretary of the IEEE Standards Board.

10.0 Appeals

The Committee recognizes the right of appeal. Appeals shall be considered by the IEEE Standards Board. Technical appeals are referred back to the sponsoring committee.

Every effort should be made to ensure that impartial handling of substantive and procedural complaints regarding any action or inaction on behalf of the Committee are handled in an identifiable and realistic manner. In addition to these operating procedures, several documents take precedence, when necessary, in order to ensure that due process and right of appeal are served.

11.0 Parliamentary Procedures

On questions of parliamentary procedure not covered by these Procedures, Robert's Rules of Order (latest edition) may be used to expedite due process.

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Revision approved January 25, 2001