Recognized standard
60601-2-23 Edition 3.0 2011-02
FDA recognition 1-87 · IEC · Anesthesiology
Key facts
| Recognition number | 1-87 |
|---|---|
| Designation | 60601-2-23 Edition 3.0 2011-02 |
| Title | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Anesthesiology |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 60601-2-23:2011 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. IEC… |
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: