Recognized standard
12609-1 Second edition 2021-10
FDA recognition 12-378 · ISO · Radiology
Key facts
| Recognition number | 12-378 |
|---|---|
| Designation | 12609-1 Second edition 2021-10 |
| Title | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| Standards developer | International Organization for Standardization |
| Specialty area | Radiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies general requirements for operators' eye protectors for intense light source(ILS) equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser… |
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: