Recognized standard
27186 First edition 2010-03-15 27186:2010
FDA recognition 3-89 · ISO · Cardiovascular
Key facts
| Recognition number | 3-89 |
|---|---|
| Designation | 27186 First edition 2010-03-15 27186:2010 |
| Title | Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jan 25, 2013 |
| Device classes | Class 3 |
| Scope (excerpt) | This International Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as… |
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: