Recognized standard
NS28:1988/(R) 2015
FDA recognition 17-1 · AAMI · Neurology
Key facts
| Recognition number | 17-1 |
|---|---|
| Designation | NS28:1988/(R) 2015 |
| Title | Intracranial pressure monitoring devices |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Neurology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes minimum labeling, safety, and performance requirements for intracranial pressure monitoring devices, whether percutaneous, fully implantable, or noninvasive. Also covered by this standard are test and calibration methods needed to establish compliance with the standard. The… |
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: