Recognized standard
11810 Second edition 2015-12-15
FDA recognition 6-363 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-363 |
|---|---|
| Designation | 11810 Second edition 2015-12-15 |
| Title | Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying… |
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: