7 Additional procedures for development and maintenance

7.1        Interpretations of standards

The AAMI standards program does not provide non-consensus interpretations of its standards or TIRs. Any verbal or written interpretations provided by committee members, chairs, or other

authorities are their personal interpretations and not the official position of AAMI or of the responsible consensus body.

If clarification of a standard is necessary, the consensus body shall revise or amend the standard to provide this clarification. Any amendment or revision shall be developed following AAMI’s full consensus procedures. Where deemed necessary, AAMI can develop a TIR to provide guidance on the application of a standard.

This provision does not prohibit the publication of corrigenda (errata) to correct clear and unambiguous errors in AAMI standards or TIRs.

7.2        Amendments of standards and TIRs

Amendments of published AAMI standards and TIRs may be proposed at any time. Requests for amendments shall be made in writing to the Standards department, shall offer specific text changes, and shall include rationale for the recommended changes. If the proposed amendment expands the scope of the original document, a new work item proposal shall be prepared and submitted to the Standards Board in accordance with 6.1.3. If the amendment does not modify the scope, the approval process shall be the same as for a standard or a TIR, whichever the base document is.

7.3        Periodic maintenance of standards

Within five years of the last approval of a current AAMI or American National Standard, the standard shall be balloted for reaffirmation to the responsible consensus.

For identical adoptions of an ISO or IEC standard, the procedures in clause 4.0 of the ANSI Procedures for the National Adoption of ISO and IEC Standards as American National Standards apply.

If a consensus body proposes to withdraw a document at any time, this proposal will be balloted and placed on public review.

Ballot forms for periodic maintenance of AAMI documents shall include the following choices:

• Reaffirm the American National Standard;

   

• Reaffirm the American National Standard and start a Revision;

   

• Withdraw;

   

• Abstain.

   

  Ballot forms for periodic maintenance of ISO or IEC adoptions shall include the following choices:

   

• Reaffirm the American National Standard and Confirm the international standard;

   

• Reaffirm the American National Standard and Revise the international standard;

   

• Withdraw both the American National Standard and the international standard;

   

• Abstain.

  Contingency votes are not allowed. Comments shall be required when voting to reaffirm and revise or to withdraw.

   

  The approval process for a reaffirmation or withdrawal of a standard follows that for the approval of a new standard except that reaffirmations without outstanding objections are not subject to Standards Board approval.

   

  If any votes to withdraw are received, the recirculation process in 6.6 shall be followed.

   

  7.4        Periodic review of TIRs

  TIRs should be reviewed every three years to determine if the document should be maintained, withdrawn, revised, or advanced to become a standard.

   

  Ballot forms for periodic maintenance of AAMI TIRs shall include the following choices:

   

  • Reaffirm the Technical Information Report;

     

  • Reaffirm the Technical Information Report and start a Revision;

     

  • Reaffirm the Technical Information Report and initiate conversion to a standard;

     

  • Withdraw;

     

  • Abstain.

     

    Contingency votes are not allowed. Comments shall be required when voting to reaffirm and revise or to withdraw. If any votes to withdraw are received, the recirculation process in 6.6 shall be followed.

     

    7.5        Withdrawal for cause (administrative withdrawal)

    The AAMI Standards Program HOD or the Standards Board can withdraw any AAMI standard or TIR upon showing objective evidence that one or more of the following conditions applies:

     

    1. A significant conflict with another AAMI standard or TIR is identified and cannot be resolved.
    2. ANSI’s requirements for designation, publication, and maintenance were violated.
    3. Supporting the document is contrary to the interests of the public or of AAMI.
    4. The document contains unfair provisions or that due process requirements were violated in the document’s development or maintenance.

       Administrative withdrawal of any American National Standard shall comply with applicable provisions for administrative withdrawal set forth in the ANSI Essential Requirements.

        

       7.6        Revisions

       A proposal to revise a standard or TIR does not require a new work proposal form. The proposal to begin a revision of a standard or TIR shall be made to the consensus body that authored the document. If the proposed revision expands the scope of the original document, a new work item proposal shall be prepared and submitted to the Standards Board in accordance with section 6.1.3. The proposal to revise a standard or TIR, outside of the provisions of sections 7.3 and 7.4, shall be discussed at a meeting (either in-person or remote), approved, and documented in a meeting report. 

       The initiation of a revision does not obviate the requirement for timely periodic review.

       A revision of a standard or TIR otherwise follows the procedures detailed in section 6 of these Policies and Procedures.

       The revision of any American National Standard shall comply with 2.5 of the ANSI Essential Requirements with regard to the submission of PINS (Project Initiation Notification System) form and announcement in ANSI Standards Action. At the initiation of a project to revise an American National Standard, notification shall be transmitted to ANSI using the Project Initiation Notification System (PINS) form, or its equivalent, for announcement in Standards Action.

        

       7.7        Continuous maintenance

       Appropriate standards or TIRs may be maintained on a continuous basis with approval of the Standards Board. A consensus body proposing continuous maintenance for one of its documents shall prepare a documented program for periodic publication of revisions and timely consideration of each formally submitted request for change. Standards Board approval of the proposal and the program is required.

        

       Continuous maintenance shall comply with all the applicable provisions of these Policies and Procedures and, for any American National Standard, with the applicable provisions of the ANSI Essential Requirements.

        

       7.8        Provisional standards

       AAMI may develop provisional American National Standards following the provisions set forth in Annex B of the ANSI Essential Requirements.

        

       7.9        Adoption of international documents by AAMI

        

       7.9.1           Adoption of international standards

       For adoptions of ISO or IEC standards, the requirements set forth in the ANSI Procedures for the National Adoption of ISO or IEC Standards as American National Standards and the applicable provisions from these Policies and Procedures apply with the following exceptions:

        

       1. A new work proposal form is not required to adopt an International Standard produced by an ISO or IEC Technical Committee or Subcommittee for which AAMI holds the U.S. TAG, nor is Standards Board approval required. The appropriate consensus body may propose and initiate adoption.
       2. Staff approval is required to adopt any document produced by an ISO or IEC Technical Committee or Subcommittee for which AAMI does not hold the U.S. TAG. Any such adoption shall comply with the ANSI Policy Regarding Rights to Nationally Adopt ISO Standards or Otherwise Use IEC and ISO Material.
       3. The expedited procedures set forth in the ANSI Procedures for the National Adoption of ISO or IEC standards as American National Standards should be employed.
       4. For parallel adoption, the consideration of comments concerns only which comments to submit (either as written or with modification) or reject for submission as part of the U.S. consensus position; however, the consensus body can decide

          to accept a comment rejected internationally and publish the adoption with deviations.

       5. For parallel adoption, the responses of the U.S. consensus body shall be provided along with the ISO or IEC documentation indicating how all comments (U.S. and non-U.S. comments) were resolved.
       6. For parallel adoption of International Standards, the AAMI Committee Draft for Vote ballot and public review occur at the international Enquiry stage (Draft International Standard for ISO and Committee Draft for Vote for IEC).
       7. Periodic maintenance shall follow the provisions for adoptions of International Standards set forth in the ANSI Essential Requirements.