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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 5-144
Standard
ISO  80369-20 Second edition 2024-11
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Scope/Abstract
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.
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.
Transition Period
FDA recognition of ISO 80369-20 First edition 2015-05-15 [Rec# 5-97] will be superseded by recognition of ISO 80369-20 Second edition 2024-11 [Rec# 5-144]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-97] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 5-97] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, Issued February 11, 2015.

(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/ORR
  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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