Recognized standard
60601-2-27 Edition 3.0 2011-03 60601-2-27:2011(R)2016
FDA recognition 3-126 · IEC · Cardiovascular
Key facts
| Recognition number | 3-126 |
|---|---|
| Designation | 60601-2-27 Edition 3.0 2011-03 60601-2-27:2011(R)2016 |
| Title | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Cardiovascular |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the… |
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: