Recognized standard
F647-94 (Reapproved 2014)
FDA recognition 17-4 · ASTM · Neurology
Key facts
| Recognition number | 17-4 |
|---|---|
| Designation | F647-94 (Reapproved 2014) |
| Title | Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| Standards developer | ASTM International |
| Specialty area | Neurology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | 1.1 This practice covers requirements for the evaluation and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies. 1.2 Devices to which this practice is applicable… |
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: