Recognized standard
10943 Fourth edition 2023-01
FDA recognition 10-134 · ISO · Ophthalmic
Key facts
| Recognition number | 10-134 |
|---|---|
| Designation | 10943 Fourth edition 2023-01 |
| Title | Ophthalmic instruments - Indirect ophthalmoscopes |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-, if… |
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: