| ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| Recognition Number | Anesthesiology |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 1-140 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| 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.
ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.
ISO 80601-2-55:2018 specifies requirements for
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.
ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.
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 subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.1720 | Analyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | CCL |
| §868.1700 | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | CBR |
| §868.1620 | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | CBS |
| §868.1500 | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NHO |
| §868.1500 | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | CBQ |
| §868.1500 | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NHQ |
| §868.1500 | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NHP |
| §868.1400 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | CCK |
| There is no relevant guidance developed at this time. |