| IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| Recognition Date | 2012-08-20 |
| Recognition List | 029 |
| Recognition Number | 1-87 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Anesthesiology |
| FDA Tech | Neel Patel FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-6274 Neel.Patel@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 60601-2-23:2011 does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the 2005 edition of IEC 60601-1.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.2500 | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | Class 2 | KLK |
| §868.2500 | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | Class 2 | LPP |
| §868.2480 | Monitor, Carbon-Dioxide, Cutaneous | Class 2 | LKD |
| Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA |