Recognized standard
60601-2-31 Edition 2.1 2011-09
FDA recognition 3-102 · IEC · Cardiovascular
Key facts
| Recognition number | 3-102 |
|---|---|
| Designation | 60601-2-31 Edition 2.1 2011-09 |
| Title | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. |
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: