STANDARDS FOR ACCESSIBLE 

MEDICAL DIAGNOSTIC 

EQUIPMENT
Background

• Section 4203 of Patient Protection and 

Affordable Care Act 

– (Public Law 111-148, 124 Stat. L. 119)

• Added Section 510 to the Rehabilitation Act 

of 1973 on March 23, 2010

• Title: “ESTABLISHMENT OF STANDARDS 

FOR ACCESSIBLE MEDICAL DIAGNOSTIC 

EQUIPMENT”
Background

• ANSI/AAMI HE75 –

2009 Human Factors 

Engineering – Design 

of Medical Devices

• Chapter 16 –

Accessibility 

Considerations
Background

ADA and ABA

Accessibility 

Guidelines 
Organization

• Preamble

• Text of the Proposed Rule

• Example Applications
Organization

• Chapter M1: Application and 

Administration

• Chapter M2: Scoping

• Chapter M3: Technical Criteria
Technical Criteria

Equipment used by patients:

• in a supine, prone, or side-lying 

position - M301

• in a seated position - M302

• seated in a wheelchair - M303 

• in a standing position - M304


Technical Criteria

• Supports - M305
Technical Criteria

Across equipment types:

• Communication 

M306

• Operable Parts 

M307
Data from 

Wheeled Mobility 

Anthropometry 

Project
Example Applications Document
Steps

• Comment Period

• Public Hearing

• Advisory Committee
Responses to NPRM

• 46 questions were posed 

in the preamble

• 51 commenters

• Range of comments
Initial Review

• Nature of responses to 

questions

• Issues affecting multiple 

interest
Recommended Issues

Issues Areas

• Transfer surface height and size

• Permitted obstructions to the 

transfer surface

• Transfer support location and 

configuration

• Depth of wheelchair spaces
Recommended Issues

Transfer Surface

Height and Size
Transfer Surface Height 

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. 
Transfer Surface Height 

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. 
Transfer Surface Height 

NPRM Question 14

Adjustability - 17 inches min. 

and 25 inches max. range

Minimum Height 
Patients

• Height is a major concern

• Range of users accommodated

Transfer Surface Height 
Manufacturers 

• Seat profile

• Components beneath transfer 

surface

• Span between the lowest transfer 

height and optimal caregiver height

• Cost and redesign

Transfer Surface Height 
Equipment Design Concerns

Transfer Surface Height 
M301.2.2 Size. The transfer surface shall be

30 inches (760 mm) wide minimum and 15 inches 

(381mm) deep minimum. 

Transfer Surface Size 
Transfer Surface Size

M302.2.2 Size. The transfer surface shall be

21 inches (610 mm) wide minimum and 15 inches 

(381 mm) deep minimum.
Transfer Surface Size 

NPRM Questions 15 and 16

Sufficiency of proposed 

requirement

Minimum width

Alternative dimensions 
Transfer Surface Size 

Patients

• Space for transfer

• Repositioning after transfers

• Range of body sizes – large 

and obese

• Ergonomics
Manufacturers

• Use of supports

• Corner shape on transfer sides

• Relationship to base design

• Equipment proportions

• Redesign and costs

• Impact on exam room layouts 

Transfer Surface Size 
Equipment Design Concerns

Transfer Surface Size 
M301 Diagnostic Equipment Used by 

Patients in Supine, Prone, or

Side-Lying Position

• Width: increase to 35 to 36 inches

decrease to 25 to 28 inches 

• Same requirement for Equipment Used 

by Patients in Seated Position

Transfer Surface Size 
M302 Diagnostic Equipment Used by 

Patients in in Seated Position

• Alternate dimensions – 17 inches 

min. depth

• Relationship to size requirement

for M301

Transfer Surface Size 
Questions?