Recognized standard
14708-2 Third edition 2019-09
FDA recognition 3-186 · ISO · Cardiovascular
Key facts
| Recognition number | 3-186 |
|---|---|
| Designation | 14708-2 Third edition 2019-09 |
| Title | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 29, 2023 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples… |
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: