Recognized standard
TIR42:2021
FDA recognition 3-172 · AAMI · Cardiovascular
Key facts
| Recognition number | 3-172 |
|---|---|
| Designation | TIR42:2021 |
| Title | Evaluation of Particulates Associated with Vascular Medical Devices |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. 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: