Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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1-191
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Standard | |
ISO 9360-2 First edition 2001-07 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml |
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Scope/AbstractThis part of ISO 9360 is based on ISO 9360-1:2000 and specifies certain requirements and test methods for heat and moisture exchangers (HMEs) without machine connector ports, including those incorporating breathing system filters. These devices are intended for the humidification of respired gases for tracheostomized patients having a tidal volume of 250 ml or greater. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5260 |
Filter, Bacterial, Breathing-Circuit
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Class 2
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CAH
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Relevant FDA Guidance and/or Supportive Publications*
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. |