Recognized standard
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION 60601-2-4:2010/A1:2018 (Consolidated Text)
FDA recognition 3-169 · IEC · Cardiovascular
Key facts
| Recognition number | 3-169 |
|---|---|
| Designation | 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION 60601-2-4:2010/A1:2018 (Consolidated Text) |
| Title | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or… |
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: