Recognized standard
18562-1 Second edition 2024-03
FDA recognition 1-173 · ISO · Anesthesiology
Key facts
| Recognition number | 1-173 |
|---|---|
| Designation | 18562-1 Second edition 2024-03 |
| Title | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies: - the general principles governing the biological evaluation within a risk management process of the 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… |
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: