36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

a. Structural Strength

The MDE NPRM proposed to require transfer supports to be capable of resisting vertical and horizontal forces of 250 pounds at all points (proposed M305.2.2). The Access Board sought input in question 18, on whether current transfer supports are capable of resisting vertical and horizontal forces of 250 pounds at all points. NPRM, 77 FR at 6925. Four commenters (three manufacturers and one accessibility consultant) addressed this requirement: the accessibility consultant concurred with the proposal and the other three commenters opposed this provision. Two of those opposing the 250-pound requirement asserted that very few supports would be able to withstand 250 pounds of force applied to all points in all directions and that the requirements should differ depending on the force vector or live load applied. The remaining opposing commenter supported compliance with the prevailing industry standard IEC 60601 instead of the proposed provision.

The MDE Advisory Committee recommended revising the language proposed in the MDE NPRM to require transfer supports to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment. The Committee indicated that “during committee discussions manufacturers stated that industry is required to test the most vulnerable spots on the transfer support. Industry must follow testing parameters found in other standards.” MDE Advisory Committee Report, 103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

After reviewing the comments received and the recommendations from the MDE Advisory Committee, the Access Board has decided to remove this section in the final rule. The prevailing standard used by industry, IEC 60601 adopted under the ANSI/AAMI ES 60601 series in the U.S., contains provisions that address the structural strength of supports. ANSI/AAMI ES60601-1:2005/(R)2012, available at http://my.aami.org. The IEC 60601 Standard applies to a wide range of medical equipment including much of the diagnostic equipment covered by the MDE Standards and contains allowances for risk assessment not found in accessibility standards, such that support features on diagnostic equipment that will sustain transfers in a safe manner even without a specific provision in the MDE Standards. Id. Accordingly, it is not necessary for the Access Board to address the structural strength of transfer supports in the final rule as it is already covered by industry standards.