Recognized standard
5841-3 Third edition 2013-04-15 5841-3:2013
FDA recognition 3-125 · ISO · Cardiovascular
Key facts
| Recognition number | 3-125 |
|---|---|
| Designation | 5841-3 Third edition 2013-04-15 5841-3:2013 |
| Title | Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods. ISO 5841-3:2013 is applicable… |
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: