Recognized standard
60601-2-47 Edition 2.0 2012-02 60601-2-47:2012/(R)2016
FDA recognition 3-155 · IEC · Cardiovascular
Key facts
| Recognition number | 3-155 |
|---|---|
| Designation | 60601-2-47 Edition 2.0 2012-02 60601-2-47:2012/(R)2016 |
| Title | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS 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… |
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: