Recognized standard
80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION
FDA recognition 6-508 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-508 |
|---|---|
| Designation | 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 80601-2-59 Edition 2.1 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets… |
At a glance
- 1–9 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: