Recognized standard
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 62366-1:2015+AMD1:2020 (Consolidated Text)
FDA recognition 5-129 · IEC · General I (QS/RM)
Key facts
| Recognition number | 5-129 |
|---|---|
| Designation | 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 62366-1:2015+AMD1:2020 (Consolidated Text) |
| Title | Medical devices - Part 1: Application of usability engineering to medical devices Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General I (QS/RM) |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This part of IEC 6 2366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with… |
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: