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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 052 Date of Entry 07/15/2019 
FR Recognition Number 1-126
Standard
ISO  11712 First edition 2009-05-15
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
Scope/Abstract
ISO 11712:2009 provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation.
ISO 11712:2009 specifies the dimensions, basic properties and method of designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this International Standard.
ISO 11712:2009 requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be -compatible.
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
§868.5110 Airway, Oropharyngeal, Anesthesiology Class 1 CAE
§868.5110 Oral Airway Assist Class 1 PHS
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.
FDA Technical Contact
 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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