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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 064 Date of Entry 05/26/2025 
FR Recognition Number 1-195
Standard
ISO  80369-2 First edition 2024-09
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
Scope/Abstract
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).

NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.

NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.

NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.

This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.

NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
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
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
§868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 CBQ
§868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHO
§868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHP
§868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHQ
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
§868.2340 Flowmeter, Tube, Thorpe, Back-Pressure Compensated Class 1 CAX
§868.5340 Cannula, Nasal, Oxygen Class 1 CAT
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 Contacts
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@fda.hhs.gov
 Annie Abraham
  FDA/OC/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 Groups (STG)
Anesthesiology (primary)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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