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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 037 Date of Recognition 10/17/2014 
FR Recognition Number 9-95
Standard
CEN EN 1615:2000
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
Scope/Abstract
This European Standard specifies requirements for the design and testing or single-use enteral feeding catheters, single-use enteral giving sets and their connection systems.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 4.1.2 Connector on the enteral giving set
Section 4.2.1 Connector on the enteral feeding catheter
Section 4.3.1 Tensile Properties
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.

This standard is recognized in part because:
Section 4.1.2 is in conflict with an existing published final guidance. See section V. Enteral Connector Risk Assessment of the guidance document cited below.
Section 4.2.1 is in conflict with an existing published final guidance. See section V. Enteral Connector Risk Assessment of the guidance document cited below.
Section 4.3.1 is in conflict with an existing published final guidance. See section V. Enteral Connector Risk Assessment of the guidance document cited below.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
Relevant FDA Guidance and/or Supportive Publications
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications Guidance for Industry and Food and Drug Administration Staff, Issued February, 2015.
FDA Technical Contacts
 Mark Antonino
  FDA/OMPT/CDRH/ODE/DRGUD/GEDB/
  240-402-9980
  Mark.Antonino@fda.hhs.gov
 Elizabeth Katz
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-2495
  elizabeth.katz@fda.hhs.gov
Standards Development Organization
CEN European Committee for Standardization https://www.cen.eu
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
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