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)]

18082 First edition 2014-06-15

Standard Organization: ISO

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)]

Recognition NumberAnesthesiology
Recognition Date2018-06-07
Recognition List049
Recognition Number1-130
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Anesthesiology
FDA Tech  Neel Patel   FDA/OMPT/CDRH/ODE/DAGID/ANDB/   301-796-6274   Neel.Patel@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

There is no relevant guidance developed at this time.


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