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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 1-120
Standard
ISO  18190 First edition 2016-11-01
Anaesthetic and respiratory equipment - General requirements for airways and related equipment
Scope/Abstract
ISO 18190:2016 specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it.
The requirements of a device-specific standard take priority over ISO 18190:2016.
NOTE General requirements contained in ISO 18190:2016 have historically been referenced in more than two other airways and related equipment standards.
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
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§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.
FDA Technical Contacts
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@fda.hhs.gov
 Annie Abraham
  FDA/OMPT/CDRH/OPEQ/OHTI/DHTIC
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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