36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM
February 8, 2012
UNITED STATES ACCESS BOARD
A FEDERAL AGENCY COMMITTED TO ACCESSIBLE DESIGN
1331 F Street, N.W. Suite 1000 • Washington, D.C. 20004‒1111
(800) 872‒2253 (voice) • (800) 993‒2822 (TTY) • Fax: (202) 272‒0081
Website: www.access-board.gov • E-mail: ta@access-board.gov
ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD
36 CFR Part 1195
[Docket No. ATBCB−2012‒0003]
RIN 3014-AA40 Medical Diagnostic Equipment Accessibility Standards
AGENCY: Architectural and Transportation Barriers Compliance Board.
ACTION: Notice of Proposed Rulemaking.
SUMMARY: The Architectural and Transportation Barriers Compliance Board (Access Board) is proposing accessibility standards for medical diagnostic equipment. The proposed standards contain minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities. The standards will allow independent entry to, use of, and exit from the equipment by individuals with disabilities to the maximum extent possible. The standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However, other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards.
DATES: Submit comments by June 8, 2012. Hearings will be held on the proposed standards on the following dates:
1. March 14, 2012, 9:30 a.m. to 12:00 p.m., Washington, DC.
2. May 8, 2012, 9:30 a.m. to 12:00 p.m., Atlanta, GA.
ADDRESSES: Submit comments by any of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Regulations.gov ID for this docket is ATBCB−2012‒0003.
• E-mail: docket@access-board.gov. Include docket number ATBCB−2012‒0003 in the subject line of the message.
• Fax: 202‒272‒0081.
• Mail or Hand Delivery/Courier: Office of Technical and Informational Services, Access Board, 1331 F Street, NW, suite 1000, Washington, DC 20004‒1111.
All comments, including any personal information provided, will be posted without change to http://www.regulations.gov and are available for public viewing.
The hearing locations are:
1. Washington, DC: Access Board Conference Room, 1331 F Street, NW., Suite 800, Washington, DC 2004.
2. Atlanta, GA: Hilton Atlanta (Meeting Rooms 309‒311), 255 Courtland Street, NE., Atlanta, GA 30303.
FOR FURTHER INFORMATION CONTACT: Earlene Sesker, Office of Technical and Information Services, Architectural and Transportation Barriers Compliance Board, 1331 F Street NW, Suite 1000, Washington, DC 20004‒1111. Telephone: (202) 272‒0022 (voice) or (202) 272‒0091 (TTY). E-mail address sesker@access-board.gov.
36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment - PREAMBLE
M101.1 Purpose.
The 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.
The standards shall be applied to diagnostic equipment based on the patient positions that the equipment is designed to support. Where diagnostic equipment is designed to support more than one patient position, the standards for each patient position supported shall be applied to the equipment.
Advisory M101.2 Application. The following examples illustrate how the standards apply to diagnostic equipment designed to support more than one patient position:
• An examination chair converts to an examination table. The technical criteria in M302 for diagnostic equipment used by patients in a seated position; and in M301 for diagnostic equipment used by patients in a supine, prone, or side-lying position apply.
• A weight scale can be used by patients seated in a wheelchair, or seated on a built-in folding seat, or standing and holding onto supports. The technical criteria in M303 for diagnostic equipment used by patients seated in a wheelchair; in M302 for diagnostic equipment used by patients in a seated position; and in M304 for diagnostic equipment used by patients in a standing position apply.
M101.3 Equivalent Facilitation.
The use of alternative designs or technologies that result in substantially equivalent or greater accessibility and usability than specified in the standards 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
M102.1 Defined Terms.
For the purpose of the standards, the following terms have the indicated meaning:
Enforcing Authority.
An agency that adopts the standards as mandatory requirements for entities subject to its jurisdiction.
Medical Diagnostic Equipment (Diagnostic Equipment).
Equipment used in or in conjunction with medical settings by health care providers for diagnostic purposes.
Operable Parts.
A component of diagnostic equipment that is used by the patient to activate, deactivate, or adjust the equipment.
Transfer Surface.
Part of diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment.
M102.2 Undefined Terms.
The meaning of terms not defined in M102.1 or in regulations or policies issued by an enforcing authority shall be defined by collegiate dictionaries in the sense that the context implies.
M102.3 Interchangeability.
Words, terms, and phrases used in the singular include the plural and those used in the plural include the singular.
M201.1 Enforcing Authority.
The enforcing authority specifies the minimum number of types of accessible diagnostic equipment that are required to comply with the standards in different types of health care facilities.
M301.1 General.
Where diagnostic equipment is used by patients in a supine, prone, or side-lying position, it shall comply with M301.
M301.2 Transfer Surface.
A transfer surface shall be provided and shall comply with M301.2.
M301.2.1 Height.
The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface.
M301.2.2 Size.
The transfer surface shall be 30 inches (760 mm) wide minimum and 15 inches (381mm) deep minimum.
M301.2.3 Transfer Sides.
The transfer surface shall be located to provide options to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface. Each transfer side shall provide unobstructed access to the transfer surface.
EXCEPTION: Temporary obstructions shall be permitted provided that they can be repositioned to permit transfer.
M301.3 Supports.
Transfer supports, stirrups, and reclining surfaces shall comply with M301.3.
M301.3.1 Transfer Supports.
Transfer supports shall be provided for use with the transfer sides required by M301.2.3 and shall comply with M305.2.
M301.3.2 Stirrups.
Where stirrups are provided, they shall provide a method of supporting, positioning, and securing the patient’s legs.
M301.3.3 Head and Back Support.
Where the diagnostic equipment is used in a reclined position, head and back support shall be provided. Where the incline of the back support can be modified while in use, head and back support shall be provided throughout the entire range of the incline.
M301.4 Lift Compatibility.
Diagnostic equipment shall be usable with a patient lift and shall comply with M301.4.1 or M301.4.2.
M301.4.1 Clearance in Base.
The base of the equipment shall provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Equipment components are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width.
M301.4.2 Clearance Around Base.
The base of the equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.
M302.1 General.
Where diagnostic equipment is used by patients in a seated position, it shall comply with M302.
M302.2 Transfer Surface.
A transfer surface shall be provided and shall comply with M302.2.
M302.2.1 Height.
The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface.
M302.2.2 Size.
The transfer surface shall be 21 inches (610 mm) wide minimum and 15 inches (381 mm) deep minimum.
M302.2.3 Transfer Sides.
The transfer surface shall be located to provide options to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface. Each transfer side shall provide unobstructed access to the transfer surface.
EXCEPTION: Temporary obstructions shall be permitted provided that they can be repositioned to permit transfer.
M302.3 Supports.
Transfer supports, armrests, and reclining surfaces shall comply with M302.3.
M302.3.1 Transfer Supports.
Transfer supports shall be provided for use with the transfer sides required by M302.2.3 and shall comply with M305.2.
M302.3.2 Armrests.
Where diagnostic equipment is used by patients in a seated position, armrests shall be provided.
M302.3.3 Head and Back Support.
Where the diagnostic equipment is used in a reclined position, head and back support shall be provided. Where the incline of the back support can be modified while in use, head and back support shall be provided throughout the entire range of the incline.
M302.4 Lift Compatibility.
Diagnostic equipment shall be usable with a patient lift and shall comply with M302.4.1 or M302.4.2.
EXCEPTION: Where diagnostic equipment meets the requirements of M303 and provides a folding seat, the equipment shall not be required to comply with M302.4.
M302.4.1 Clearance in Base.
The base of the equipment shall provide a clearance 44 inches (1120 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Equipment components are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width.
M302.4.2 Clearance Around Base.
The base of the equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.
M303.1 General.
Diagnostic equipment used by patients seated in a wheelchair shall comply with M303.
M303.2 Wheelchair Spaces.
A wheelchair space complying with M303.2 shall be provided at diagnostic equipment.
M303.2.1 Orientation.
Wheelchair spaces shall be designed so that a patient seated in a wheelchair orients in the same direction that a patient not seated in a wheelchair orients when the diagnostic equipment is in use.
M303.2.2 Width.
Wheelchair spaces shall be 36 inches (915 mm) wide minimum.
M303.2.3 Depth.
Where wheelchair spaces can be entered from the front or rear, the wheelchair space shall be 48 inches (1220 mm) deep minimum. Where wheelchair spaces can be entered only from the side, the wheelchair space shall be 60 inches (1525 mm) deep minimum.
M303.2.4 Knee and Toe Clearance.
Wheelchair spaces shall include knee and toe clearance complying with M303.2.4. The depth of the wheelchair space shall include knee and toe clearance of 17 inches (430 mm) minimum and 25 inches (635 mm) maximum. Knee and toe clearance under breast platforms shall be 25 inches (635 mm) deep.
Toe clearance shall be provided at a height of 9 inches (230 mm) above the floor to a depth of 6 inches (150 mm) maximum.
Knee clearance shall be provided at a depth of 11 inches (280 mm) minimum and 25 inches (635 mm) maximum at 9 inches (230 mm) above the floor and at a depth of 8 inches (205 mm) minimum at 27 inches (685 mm) above the floor. Between 9 inches (230 mm) and 27 inches (685 mm) above the floor, the knee clearance shall be permitted to reduce at a rate of 1 inch (25 mm) in depth for every 6 inches (150 mm) in height.
M303.2.5 Surfaces.
Wheelchair space surfaces shall not slope more than 1:48 in any direction.
M303.3 Entry.
Where there is a change in level at the entry to a wheelchair space, the change in level shall comply with M303.3.
M303.3.1 Vertical.
Changes in level of ¼ inch (6.4 mm) high maximum shall be permitted to be vertical.
M303.3.2 Beveled.
Changes in level between ¼ inch (6.4 mm) high and ½ inch (13 mm) high maximum shall be beveled with a slope not steeper than 1:2.
M303.3.3 Ramped.
Changes in level greater than ½ inch (13 mm) high shall be ramped and shall comply with M303.3.3.
Ramp runs shall have a running slope not steeper than 1:12.
The cross slope of ramp runs shall not be steeper than 1:48.
The clear width of ramp runs shall be 36 inches (915 mm) minimum.
Ramps with drop offs ½ inch (13 mm) or greater shall provide edge protection 2 inches (50 mm) high minimum on each side.
Ramps with a rise greater than 6 inches (150 mm) shall provide handrails on each side.
M303.4 Components.
Where components of diagnostic equipment are used to examine specific body parts, the components shall be capable of examining the body parts of a patient seated in a wheelchair. Breast platforms shall comply with M303.4.1.
M303.4.1 Breast Platforms.
The height of the breast platform shall be 30 inches (760 mm) high minimum and 42 inches (1065 mm) high maximum above the floor when in use by a patient seated in a wheelchair.
M304.1 General.
Diagnostic equipment used by patients in a standing position shall comply with M304.
M304.2 Standing Surface.
The surface on which the patient stands shall be slip resistant.
M304.3 Standing Supports.
Standing supports shall be provided on each side of the standing surface and shall comply with M305.3.
M305.1 General.
Supports shall comply with M305, as applicable.
M305.2 Transfer Supports.
Transfer supports shall comply with M305.2.
M305.2.1 Location.
Transfer supports shall be located within reach of the transfer surface and shall not obstruct transfer onto or off of the surface when in position.
M305.2.2 Structural Strength.
Transfer supports and their connections shall be capable of resisting vertical and horizontal forces of 250 pounds (1,112 N) applied at all points on the transfer support.
M305.2.3 Fittings.
Transfer supports shall not rotate within their fittings.
M305.3 Standing Supports.
Standing supports shall provide continuous support throughout use of the diagnostic equipment and shall comply with M305.3.
M305.3.1 Horizontal Position.
Where the support is horizontal, the top of the gripping surface shall be 34 inches (865 mm) minimum and 38 inches (965 mm) maximum above the standing surface. The gripping surface shall be 4 inches (100 mm) long minimum.
M305.3.2 Vertical Position.
Where the support is vertical, it shall be 18 inches (455 mm) minimum in length and the bottom end of the support shall be 34 inches (865 mm) high minimum and 37 inches (940 mm) high maximum above the standing surface.
M305.3.3 Fittings.
Standing supports shall not rotate within their fittings.
M306.1 General.
Where instructions or other information is communicated to the patient through the diagnostic equipment, the instructions and other information shall be provided in at least two of the following methods: audible, visible, or tactile.
M307.1 General.
Operable parts for patient use shall comply with M307.
M307.2 Tactilely Discernible.
Operable parts shall be tactilely discernible without activation.
M307.3 Operation.
Operable parts shall be operable with one hand and shall not require tight grasping, pinching, or twisting of the wrist.
M307.4 Operating Force.
The force required to activate operable parts shall be 5 pounds (22.2 N) maximum.
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