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

M101.6 Dimensional Tolerances (Section-by-Section Analysis)

The MDE NPRM proposed that dimensions were to be subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. In the preamble of the MDE NPRM, the Access Board sought public input in question five on available information or resources concerning conventional industry tolerances for medical diagnostic equipment. NPRM, 77 FR at 6920. Six commenters responded to the question. Three commenters (two manufacturers and one medical association) indicated that tolerances vary based on the manufacturer, product design, and manufacturing process and that they are unaware of any industry standard. One commenter, a manufacturer, referenced ASME Y14.5-1994 for dimensional tolerances. Another commenter, a medical association, asserted that tolerances are in operator manuals. The final commenter, a manufacturer, recommended providing tolerances when dimensions are specified and recommended defining a specific tolerance, such as +/- 0.5 inch for linear dimensions.

After considering the comments received, the Access Board has decided to retain the original provision. The Access Board was persuaded by arguments from the commenters that there is not one industry-wide standard that can be applied to all MDE and concurs that the Access Board should not attempt to establish manufacturing tolerances. Where available, tolerances are best addressed by industry standards for the specific materials and methods employed in the manufacturing process. The only change to this provision was to adjust the section number to allow for the addition of a new section, M101.3 Existing Diagnostic Equipment.