Recognized standard
HE75:2009/(R)2018
FDA recognition 5-57 · ANSI · General I (QS/RM)
Key facts
| Recognition number | 5-57 |
|---|---|
| Designation | HE75:2009/(R)2018 |
| Title | Human factors engineering - Design of medical devices |
| Standards developer | American National Standards Institute |
| Specialty area | General I (QS/RM) |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | 1.1 General This recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The material emphas adoption of a user-centered focus throughout the product design and development… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: