Recognized standard
8836 Fifth edition 2019-12
FDA recognition 1-150 · ISO · Anesthesiology
Key facts
| Recognition number | 1-150 |
|---|---|
| Designation | 8836 Fifth edition 2019-12 |
| Title | Suction catheters for use in the respiratory tract |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment… |
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: