6 Development of consensus standards and TIRs

6.1        New Work Proposal

6.1.1           Initiating new work

AAMI shall make available a new work proposal form detailing information necessary to consider developing a new standard or TIR. To propose new work, a completed form shall be submitted to the AAMI Standards Department. Any individual or organization having a material interest may propose new work, but the work must be within the standards program’s approved scope.

Whenever possible, a detailed outline or first draft of the proposed document should accompany the proposal.

AAMI staff will review all new work item proposals for completeness, clarity, and to ensure such work is not already in AAMI’s program of work or that of another standards developing organization. Where appropriate, staff may request that proposals be amended to correct deficiencies, provide clarity, or respond to questions.

6.1.2           Evaluation and approval of new work

Proposals may be sent to appropriate parties within AAMI for review. Where appropriate, input may be sought from outside stakeholders with regard to the need and feasibility of the proposed work, as well as to determine whether AAMI is the appropriate organization to develop the work. Such review may include distribution to related AAMI committees, working groups, or other experts for evaluation.

6.1.3           Approval of new work

After completion of the evaluation, staff shall submit the new work proposal for consideration by the AAMI Standards Board with all received input from review and any observations by staff.

The Standards Board shall consider the need for the new work, the priority of the work for AAMI, the feasibility of completing the work, whether the work is in AAMI’s scope, and whether AAMI has sufficient resources—including stakeholder participation and current consensus body workload—to undertake the new work. In addition, the Standards Board should consider whether a more appropriate technical organization should undertake the work.

The Standards Board approves the initiation of new work or the formation of a consensus body at an in-person meeting, conference call or web meeting. In order to be approved, at least two- thirds of those members participating in the meeting must support the proposal.

6.1.4           Conversion of a published TIR to an American National Standard

In the event that a consensus body agrees that a published TIR should be revised and converted to a standard, a new work item proposal form shall be completed and the approval process for a standard followed.

6.1.5           Creation and termination of consensus bodies

If the work does not fall under the scope of any existing AAMI consensus body, the AAMI Standards Board may authorize the formation a new consensus body to develop the proposed standard or TIR.

The Standards Board also may dissolve a consensus body and terminate its program of work, based on lack of progress, apparent lack of interest, or other cause.

The decision to dissolve a consensus body can be appealed.

6.1.6           Announcement of new consensus body or new work project

Upon Standards Board approval, new work items shall be publicly announced in AAMI publications, on the AAMI website, or by other appropriate means. For documents proposed as American National Standards, announcements shall comply with the ANSI Essential Requirements. Announcements of new work on prospective standards shall comply with the requirements for openness.

6.1.7           Outreach

Standards staff shall perform and document outreach to materially interested parties to promote participation of interested stakeholders and a balance of interests on the consensus body.

6.2        Working Draft stage

The consensus body shall prepare the initial Working Draft in accordance with AAMI practices, procedures, and editorial style.

After the initial Working Draft has been prepared, the document is circulated to the responsible consensus body for review and comment. Written responses are not required to comments submitted at the Working Draft stage. The consensus body is not obligated to consider comments submitted after the comment deadline.

Comments from individuals outside of the consensus body (e.g., from another related AAMI consensus body) are not normally accepted at this stage but can be, at the discretion of the co- chairs. However, AAMI is not obligated to notify the commenter of their resolution.

Several iterations may be required at the Working Draft stage before advancing a TIR for ballot or a proposed standard for concurrent ballot and public review.

6.3        Committee ballot and public review (Committee Draft for Vote (CDV))

6.3.1           Decision to initiate ballot and public review

After a decision has been made that a document is ready for formal consensus body ballot and, for a standard, proposed public review, it is designated a CDV. The decision to issue a CDV can be made by the co-chairs or by a consensus of voting members present at a meeting (subject to approval by AAMI staff).

6.3.2           Formal consensus body ballot

Proposed standards or TIRs are voted on by the responsible consensus body only. Other consensus bodies may be offered the opportunity to comment on the draft document but may not vote on the documents.

All formal consensus body voting on the approval of a draft document as a standard or TIR shall be conducted electronically, and all members of the consensus body shall have the opportunity to vote.

AAMI staff conduct all approval ballots. A copy of the draft document with all necessary background information shall be distributed to voting consensus body members with instructions.

6.3.3           Ballot period

The ballot period for an approval ballot generally is six weeks. Shorter ballot periods are discouraged. No standard or TIR CDV approval ballot shall be less than three weeks.

6.3.4           Voting

Consensus body members may vote in the affirmative (e.g., “affirmative,” “yes,” or “approve”), in the negative (e.g., “negative," “no,” or “disapprove”) or may abstain. A consensus body member should vote in the affirmative if the member endorses the document whether or not his or her comments are accepted. A consensus body member should vote in the negative if substantive technical changes are necessary to resolve one or more of the member’s comments.

Negative votes shall be accompanied by comments; otherwise, they shall be recorded as “negative without comments” without further notice to the voter. Affirmative votes may include comments; however, a vote of approval cannot be contingent upon acceptance of those comments.

Abstentions should be accompanied by an explanation.

All comments and objections, whether accompanying affirmative or negative ballots, shall be specific and include, at a minimum, the following information:

• a) the clause, subclause, figure, or table containing the content in question;
• b) the rationale for the objection; and
• c) an indication as to whether the comment is technical, editorial, or general in nature.

6.3.5           Ballot return and approval requirements

For a ballot to be valid, at least two-thirds of the consensus body members shall record a vote or an abstention. For a document to be considered as approved, at least two-thirds of those voting (excluding abstentions) must return an affirmative vote (with or without comments).

6.3.6           Public review

Public review is a process by which proposed standards are made available for review by interested parties.

AAMI TIRs are not subject to public review.

Public comment is solicited by notice in appropriate AAMI publications or on the AAMI website and, for standards intended as American National Standards, by announcement in accordance with the requirements set forth in the ANSI Essential Requirements. This notice shall announce the proposed standard, state its availability for review and comment, explain how to obtain a copy of the document, and provide a deadline for submitting comments.

Proposals for new American National Standards and proposals to revise, reaffirm, or withdraw approval of existing American National Standards shall be transmitted to ANSI using the BSR-8 form, or its equivalent, for listing in Standards Action in order to provide an opportunity for public comment.

The public review period shall be in accordance with the provisions of the ANSI Essential Requirements.

AAMI public review periods may be extended at the discretion of the staff.

6.4        Consideration of and responding to comments

6.4.1           Return of comments

Public review commenters must provide comments using the AAMI public review comment template and consensus body members must provide comments via AAMI Standards Management Platform. AAMI reserves the right to return for resubmission any ballot or public review comments that are not provided through the specified format or that reference a specific company, product, or product line other than the commenter's company or product, unless the comment refers to a section of a proposed draft that cites the specific company, product, or product line.

All comments shall be specific and include, at a minimum, the information listed in 6.3.4 a) through c). To streamline the process of resolving comments, consensus body members and public review commenters may provide alternative text that would resolve their comments. However, comments shall not be dismissed due to the fact that they do not necessarily provide alternative language or a specific remedy to the negative vote.

6.4.2           Response to ballot and public comments

6.4.2.1              Rationale for not accepting a comment

For any technical comment that is not accepted, the consensus body shall provide an explanation for the rejection in writing. If the comment is understandable, specific, and offers a rationale, the explanation shall explain a technical basis for rejecting the comment. The response may refer to an explanation provided in response to another comment. The consensus body’s explanation for rejecting other types of comments may be of a more general nature.

6.4.2.2              Withdrawn comments

The consensus body is not required to respond to comments that are withdrawn by the submitter. “Comment withdrawn” shall only be entered into the resolution column at the request of the commenting member or alternate.

6.4.2.3              Late comments

The consensus body is not required to consider or respond to comments received after committee ballot or public review closure, when deciding whether to advance the document. Consensus body members that submit late comments shall be notified if their comments will not be considered and, if the document is to be reballoted, the late commenter shall be informed in that same communication that there will be another opportunity to provide input.

Late public review commenters shall be notified that they did not meet the deadline, but they may submit comments if there will be a subsequent public review.

6.4.2.4              Comments not related to the proposal undergoing ballot

The consensus body also is not required to consider comments that are not related to the proposal; however, such comments shall be documented with the resolution stating that the comment is not germane to the proposal under consideration. and the commenter invited to submit a proposal for new work.

6.4.2.5              Negative votes without comment

Negative votes without comments shall be treated in accordance with the provisions set forth in the ANSI Essential Requirements.

6.4.2.6                Unresolved objections

Unresolved objections exist when a negative vote is sustained by a member of the consensus body or when written comments submitted during public review have not been resolved in accordance with the provisions set forth in the ANSI Essential Requirements.

6.4.2.7              Distribution of responses

The compilation of comments and their resolutions, including the reasons therefore, shall be distributed electronically to all consensus body members. Each public review comment considered by the consensus body and its resolution, including the reasons therefore, shall be provided to the public review commenter.

6.5        Decision regarding further action

Following the resolution of comments, the consensus body may decide to either reballot the document or to move the document to the final approval stage. If the decision is made to reballot, the procedures in 6.3 and 6.4 shall be followed.

If the decision is made to move the document into the final approval stage, an-y substantive technical changes made to a draft standard as a result of the resolution of comments shall undergo public review. This provision does not apply to draft TIRs.

NOTE               For the purposes of these procedures, ANSI’s definition of “substantive change” from Annex A of the ANSI Essential Requirements applies.

If there have been substantive changes or there are outstanding objections to approval, submission for final approval is subject to final consensus body 15-day review (recirculation), following completion of subsequent public review(s), before submission to the AAMI Standards Board (see 6.6).

6.6        Final consensus body review and notice to public reviewers (final 15-day review)

6.7        Standards Board approval of final documents

6.7.1           General

Only the Standards Board can certify that AAMI standards or TIRs were developed in accordance with these Policies and Procedures, and authorize publication as final AAMI documents, or, if applicable, can authorize the submission of a document to ANSI for final approval as an American National Standard.

6.7.2           Procedural review

The Standards Board decision to approve a standard or TIR requires that consensus has been established in accordance with the Policies and Procedures and all ballot and public comments have received fair consideration and response. The Standards Board is not expected to conduct a technical review or technical evaluation of comments or objections, but they are expected to review the documentation to ensure that it conforms with AAMI polices.

6.7.3           Documentation

In its decision making, the Standards Board reviews the following documentation:

a) copies of all consensus body and public comments on the last approval ballot and public review;

b) the consensus body's responses to those comments;

c) any further comments from persons objecting to the disposition of their comments; and

d) objections to the finalization of the document and any other documentation that staff deems relevant.

6.7.4           Standards Board action

The Standards Board may take final action on a consensus document at a meeting or by electronic ballot. For electronic ballot, the following procedure applies:

a) All relevant documentation shall be circulated to the members of the Standards Board with the electronic ballot. The initial voting period is a minimum of 14 calendar days and subject to extension if insufficient response is received.

b) The ballot offers each member the opportunity to vote for final approval, to abstain, or to vote, with an explanation, for holding the matter for deliberation via a meeting or conference call/web meeting. Any vote to hold the decision for deliberation is honored.

c) Two-thirds (67%) of the voting membership of the Standards Board must return ballots in order for a vote to have a valid return.

When the SB takes a final action on a consensus document at a meeting, the following procedure applies:

a) All relevant documentation should be circulated to the members of the Standards Board a minimum of two weeks in advance of the meeting.

b) Decisions on final actions at a meeting shall be made by motion and votes of those voting members who are present.

c) Voting members who are not able to attend a meeting and wish to record a formal abstention or objection to approval of a final action shall communicate their position in writing to the AAMI staff no less than three business days in advance of the meeting, and must provide the rationale for such position. Voting members who are unable to attend the meeting and do not submit an objection or abstention with rationale by the deadline shall be considered as consenting to approval of a final action.

d) At least two-thirds of those voting in the meeting (excluding abstentions) shall vote to approve the final action in order for the motion to carry.

6.7.5           Denial of approval

If the Standards Board denies approval, the document is returned to the responsible consensus body along with explanation for the disapproval.

6.7.6           Notification to objectors

Any consensus body member or public reviewer maintaining an objection to approval of the standard or TIR shall be informed in writing or by email of the Standards Board decision to approve a document and, if appropriate, advance for ANSI approval. Those parties also shall be informed in writing or by email that appeal rights exist under these Policies and Procedures and that they may file an appeal in accordance with those procedures.

6.8        Publication

Consensus documents shall be published and made available as soon as possible upon final approval or reaffirmation. Publication of standards approved as American National Standards shall comply with the requirements given in the ANSI Essential Requirements. AAMI retains the right to withdraw any AAMI standard or TIR for any reason at any time, without further level of review.

6.9        Records

All records of the development and approval of any consensus document under periodic maintenance shall be retained for one complete development cycle, or until the document is revised.

Records concerning withdrawn consensus documents shall be retained for at least five years from the date of withdrawal.

Records of any American National Standard shall be kept in accordance with the requirements of the ANSI Essential Requirements.

6.10          Discontinuation of a standards project

AAMI may decide to abandon or discontinue the processing of a proposed new or revised standard or TIR or portion thereof at its own discretion and without a vote of the relevant consensus body.

For candidate American National Standards or technical information reports, the AAMI Standards Board shall be notified.

For candidate American National Standards, AAMI shall notify ANSI immediately of any such decision.