| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
064
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Date of Entry 05/26/2025
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|
FR Recognition Number
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1-193
|
| Standard | |
ISO 18190 Second edition 2025-02
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
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Scope/Abstract| This document specifies the general requirements common to airway devices and related equipment. |
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| Extent of Recognition
|
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| FDA recognition of ISO 18190 First edition 2016-11 [Rec# 1-120] will be superseded by recognition of ISO 18190 Second edition 2025-02 [Rec# 1-193]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-120] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 1-120] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5730 |
Tube, Tracheal (W/Wo Connector)
|
Class 2
|
BTR
|
| §868.5740 |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
Class 2
|
CBI
|
| §868.5800 |
Tube, Tracheostomy (W/Wo Connector)
|
Class 2
|
BTO
|
| §868.5800 |
Tube Tracheostomy And Tube Cuff
|
Class 2
|
JOH
|
|
Relevant FDA Guidance and/or Supportive Publications*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
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 Contacts
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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. |
