| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
049
|
Date of Entry 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/AbstractISO 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
|
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 |
| §868.2700 |
Regulator, Pressure, Gas Cylinder
|
Class 1
|
CAN
|
| §868.5750 |
Cuff, Tracheal Tube, Inflatable
|
Class 2
|
BSK
|
| §868.5895 |
Ventilator, Continuous, Facility Use
|
Class 2
|
CBK
|
| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
|
Class 2
|
MNT
|
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
