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Recognized Consensus Standards

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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
U.S. 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.
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) Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tubingandluermisconnections/ucm313322.htm
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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