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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 051 Date of Entry 01/14/2019 
FR Recognition Number 5-121
Standard
ISO  80369-1 Second edition 2018-11
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
Scope/Abstract
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These healthcare fields include, but are not limited to:
- breathing systems and driving gases;
- enteral;
- limb cuff inflation;
- neuraxial;
- intravascular or hypodermic.

This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the
ISO 80369 series.

This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, Issued February 3, 2016.

(Website) Medical Device Connectors: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors

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
 Scott A. Colburn
  FDA/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  301-796-6287
  scott.colburn@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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