36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

Chapter M1 Application and Administration

M101.1 Purpose

The proposed standards contain technical criteria for medical diagnostic equipment that is accessible to and usable by patients with disabilities. The standards provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible.

M101.2 Application

As discussed above under Organization of Technical Criteria, the technical criteria are to be applied to medical diagnostic equipment based on the following patient positions that the equipment is designed to support:

• Equipment used by patients in a supine, prone, or side-lying position (see M301);

• Equipment used by patients in a seated position (see M302);

• Equipment used by patients seated in a wheelchair (see M303); and

• Equipment used by patients in a standing position (see M304).

The diagnostic equipment’s labeling, instructions, and promotional material usually identify the patient positions that the equipment is designed to support. Where diagnostic equipment is designed to support more than one patient position, the technical criteria for each patient position supported are to be applied to the equipment. Advisory M101.2 includes examples of diagnostic equipment designed to support more than one patient position and the technical criteria that apply to the equipment.

M101.3 Equivalent Facilitation

The use of alternative designs and technologies that result in substantially equivalent or greater accessibility than specified in the proposed standards is permitted. Generally, alternative designs or technologies that rely on assisted transfer only (e.g., use of a patient lift) are not permitted because they do not provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible. However, the standards include technical criteria for clearance in or around the base of the equipment for lift compatibility to allow the use of a patient lift by patients with disabilities for whom independent transfer may not be possible, and the use of alternative designs or technologies for lift compatibility is permitted.

M101.4 Dimensions

The standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as “maximum” or “minimum” are absolute.

M101.5 Dimensional Tolerances

Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.

Question 5. What information or resources are available concerning conventional industry tolerances for manufactured equipment such as medical diagnostic equipment?

M102.1 Defined Terms

The following terms are defined in the proposed standards: Enforcing authority, medical diagnostic equipment, operable parts, and transfer surface.

The definition of medical diagnostic equipment is based on Section 510 of the Rehabilitation Act and means equipment used in or in conjunction with medical settings by health care providers for diagnostic purposes. For convenience purposes, the shorter term diagnostic equipment is used in place of medical diagnostic equipment after that term is first used in the standards. Examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment are examples of diagnostic equipment to which the standards apply.

The definitions of enforcing authority, transfer surface, and operable parts are discussed respectively under M201.1; M301.2 and M302.2; and M307.

Question 6. Should other terms in the proposed standards be defined? Comments should identify specific terms in the proposed standards that should be defined and, where possible, recommend definitions.

M102.2 Undefined Terms

Collegiate dictionaries are used to define terms that are not defined in the proposed standards or in regulations or policies issued by the enforcing authority.

M102.3 Interchangeability

Singular and plural words, terms, and phrases are used interchangeably.