Recognized standard
18562-4 First edition 2017-03
FDA recognition 1-137 · ISO · Anesthesiology
Key facts
| Recognition number | 1-137 |
|---|---|
| Designation | 18562-4 First edition 2017-03 |
| Title | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | ISO 18562-4:2017 specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this… |
At a glance
- 10–99 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: