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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 1-130
Standard
ISO 18082 First edition 2014-06-15
Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
Scope/Abstract
ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute.

ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases:

-oxygen;

-nitrous oxide;

-medical air;

-helium;

-carbon dioxide;

-xenon;

-specified mixtures of the gases listed above;

-oxygen-enriched air;

-air for driving surgical tools;

-nitrogen for driving surgical tools;

-use with vacuum.

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
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5750 Cuff, Tracheal Tube, Inflatable Class 2 BSK
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Neel Patel
  FDA/OMPT/CDRH/ODE/DAGID/ANDB/
  301-796-6274
  Neel.Patel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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