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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 037 Date of Entry 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.
Transition Period
FDA recognition of CEN EN 1615:2000 [Rec# 9-95] and CEN EN 1618:1997 [Rec# 9-113] will be superseded by recognition of ISO 20695 First edition 2020-03 [Rec# 9-138]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-95] and [Rec# 9-113] until July 7, 2024. After this transition period, declarations of conformity to [Rec# 9-95] and [Rec# 9-113] will not be accepted.
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.

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
 Sivakami Venkatachalam
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA
  301-796-9103
  Sivakami.Venkatachalam@fda.hhs.gov
Standards Development Organization
CEN European Committee for Standardization https://www.cen.eu
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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