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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 040 Date of Entry 08/14/2015 
FR Recognition Number 5-97
Standard
ISO  80369-20 First edition 2015-05-15
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Identical Adoption
ANSI AAMI ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Scope/Abstract
This part of ISO 80369 specifies the test methods to evaluate the performance requirements for smallbore connectors specified in the ISO 80369- 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FDA recognition of ISO 80369-20 First edition 2015-05-15 [Rec# 5-97] will be superseded by recognition of ISO 80369-20 Second edition 2024-11 [Rec# 5-144].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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