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

G. ANSI/AAMI HE 75

In 2009, the Association for the Advancement of Medical Instrumentation issued ANSI/AAMI HE 75, a recommended practice on human factors design principles for medical devices. Chapter16 of ANSI/AAMI HE 75 contains recommended practices regarding accessibility for patients and health care personnel with disabilities. Chapter 16 of ANSI/AAMI HE 75 is available at: http://www.aami.org/he75.

The Access Board is committed to using voluntary consensus standards where practical and consistent with the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note). The Access Board has considered the recommended practices in Chapter 16 of ANSI/AAMI HE 75 in developing the technical criteria for the proposed standards. The technical criteria are generally consistent with and supplement the recommended practices in Chapter 16 of ANSI/AAMI HE 75. The Access Board seeks to promote harmonization of its guidelines and standards with voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75.

Question 1. Are there other voluntary consensus standards for medical diagnostic equipment that address accessibility for patients with disabilities, or are considering addressing accessibility for patients with disabilities in future revisions to the standards?