Recognized standard
10936-2 Second edition 2010-01-15
FDA recognition 10-66 · ISO · Ophthalmic
Key facts
| Recognition number | 10-66 |
|---|---|
| Designation | 10936-2 Second edition 2010-01-15 |
| Title | Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 2, 2011 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery. |
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: