Recognized standard
10939 Third edition 2017-05
FDA recognition 10-122 · ISO · Ophthalmic
Key facts
| Recognition number | 10-122 |
|---|---|
| Designation | 10939 Third edition 2017-05 |
| Title | Ophthalmic instruments - Slit-lamp microscopes |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 10939:2017, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: