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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 059 Date of Entry 12/19/2022 
FR Recognition Number 5-139
Standard
ISO  18250-3 First edition 2018-06
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
Scope/Abstract
This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs.

This document does not specify the dimensions and requirements for the medical devices or accessories that use these 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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5980 Gastrointestinal tube and accessories. Tube, Nasogastric Class 2 BSS
§876.5980 Gastrointestinal tube and accessories. Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Gastrointestinal tube and accessories. String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Gastrointestinal tube and accessories. Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 Gastrointestinal tube and accessories. Tube, Feeding Class 2 FPD
§876.5980 Gastrointestinal tube and accessories. Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Gastrointestinal tube and accessories. Tubes, Gastrointestinal (And Accessories) Class 2 KNT
§876.5980 Gastrointestinal tube and accessories. Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Gastrointestinal tube and accessories. Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Gastrointestinal tube and accessories. Enteral Syringes With Enteral Specific Connectors Class 2 PNR
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions 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

ENFit low dose tip (LDT) syringes labeling change request letter. October, 2021.
https://www.fda.gov/media/152862/download

Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets. February, 2022.
https://www.fda.gov/medical-devices/safety-communications/potential-risk-strangulation-children-who-use-enteral-feeding-delivery-sets

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
 Mark Antonino
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  240-402-9980
  Mark.Antonino@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
General I (QS/RM) (primary)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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