Recognized standard
7197 Third edition 2006-06-01
FDA recognition 17-12 · ISO · Neurology
Key facts
| Recognition number | 17-12 |
|---|---|
| Designation | 7197 Third edition 2006-06-01 |
| Title | Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Neurology |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs. For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This… |
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: