Recognized standard
14708-5 Second edition 2020-05
FDA recognition 3-170 · ISO · Cardiovascular
Key facts
| Recognition number | 3-170 |
|---|---|
| Designation | 14708-5 Second edition 2020-05 |
| Title | Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single… |
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: