Recognized standard
14708-6 Second edition 2019-09
FDA recognition 3-187 · ISO · Cardiovascular
Key facts
| Recognition number | 3-187 |
|---|---|
| Designation | 14708-6 Second edition 2019-09 |
| Title | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
| 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 implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: