Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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1-140
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Standard | (Included in ASCA) |
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 |
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Scope/AbstractISO 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.
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ISO 80601-2-55 Second edition 2018-02 [Rec# 1-140] will be superseded by recognition of ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] [Rec# 1-184]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-140] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-140] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.1400 |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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Class 2
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CCK
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§868.1500 |
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
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Class 2
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CBQ
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§868.1500 |
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
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Class 2
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NHO
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§868.1500 |
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
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Class 2
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NHP
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§868.1500 |
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
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Class 2
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NHQ
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§868.1620 |
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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Class 2
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CBS
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§868.1700 |
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
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Class 2
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CBR
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§868.1720 |
Analyzer, Gas, Oxygen, Gaseous-Phase
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Class 2
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CCL
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Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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