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This is the Preamble to the Proposed MDE Standards NPRM (2012). Click here to view the Preamble to the Final MDE Standards (2017).

Supports (M301.3, M302.3, and M305.2)

ANSI/AAMI HE 75 recommends that handholds be “integrated into the device . . . [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.” See ANSI/AAMI HE 75, section 16.4.6. M301.3, M302.3, and M305.2 provide technical criteria for transfer and positioning supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. Some supports such as armrests and side rails can be used for transferring and positioning. As discussed under M301.2.3 and M302.2.3, transfer and positioning supports on the transfer sides of transfer surfaces would have to be capable of being repositioned (e.g., folding armrests, removable side rails, retractable footrests and stirrups) to permit transfer.

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