Recognized standard
14708-1 Second edition 2014-08-15 14708-1:2014
FDA recognition 3-156 · ISO · Cardiovascular
Key facts
| Recognition number | 3-156 |
|---|---|
| Designation | 14708-1 Second edition 2014-08-15 14708-1:2014 |
| Title | Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be… |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO 14708-1:2014 is applicable not… |
At a glance
- None 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: