36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble
4. Organization of Technical Criteria
Medical diagnostic equipment is typically designed to support patients in certain positions. For example, imaging equipment can be designed for use by patients lying on a platform bed, in a standing or seated position, or seated in a wheelchair. Examination chairs can be designed to recline and be used as examination tables. The technical criteria for providing patients with disabilities access to and use of each of these equipment types would differ based on the patient positions that the equipment is designed to support. Therefore, the technical criteria in the proposed standards are organized functionally by the patient positions that the equipment is designed to support instead of by types of equipment. Where equipment is designed to support more than one patient position, the equipment would have to meet the technical criteria for each position supported.
The table below shows the four basic patient positions that medical diagnostic equipment can be designed to support; the equipment features that are addressed in the technical criteria for each of the patient positions; and the types of equipment to which the technical criteria apply for each of the patient positions. For example, X-ray equipment that is designed for use in a standing position for certain procedures would have to meet the technical criteria for slip resistant standing surface and standing supports for patients who use mobility aids such as canes or crutches, or who have limited stamina or other conditions that affect their ability to maintain balance. Mammography equipment that is designed for use by patients seated in a wheelchair would have to meet the technical criteria for wheelchair spaces, changes in level at entry to the wheelchair space, and height of the breast platform. The types of equipment listed in the last column of the table are meant to be illustrative. The technical criteria apply to any type of medical diagnostic equipment that is designed to support the patient positions indicated.
| Patient Positions Equipment Designed to Support | Equipment Features Addressed in Technical Criteria | Types Of Equipment To Which Technical Criteria Applies |
| Supine, prone, or side-lying position (M301) | Transfer surface, including height, size, and transfer sides
Transfer supports, stirrups, and head and back support Lift compatibility |
Examination tables
Imaging equipment designed for use with platform beds Examination chairs designed to recline and be used as examination tables |
| Seated position (M302) | Transfer surface, including height, size, and transfer sides
Transfer supports, armrests, and head and back support Lift compatibility |
Examination chairs
Imaging equipment designed for use with a seat Weight scales designed for use with a seat |
| Seated in a wheelchair (M303) | Wheelchair space, including orientation, width, depth, knee and toe clearance, and surface slope
Changes in level at entry to wheelchair space, including ramps Components capable of examining body parts of patients seated in a wheelchair, including height of breast platforms |
Imaging equipment designed for wheelchair use
Weight scales designed for wheelchair use |
| Standing position (M304) | Slip resistant standing surface
Standing supports |
Imaging equipment designed for use in standing position
Weight scales designed for use in standing position
|
The proposed standards also include technical criteria for supports (see M305), for instructions or other information communicated to patients through the equipment (see M306), and for operable parts used by patients (see M307).
Question 3. In organizing the technical criteria functionally by the patient positions that medical diagnostic equipment is designed to support, is it clear which technical criteria apply to different types of equipment? If not, how should the technical criteria be organized so it is clear which technical criteria apply to different types of equipment?
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