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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 1-140
Standard(Included in ASCA pilot)
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
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
§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
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
FDA Technical Contact
 Neel Patel
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.