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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 9-113
Standard
CEN EN 1618:1997
Catheters other than intravascular catheters - Test methods for common properties
Scope/Abstract
Specifies test methods for corrosion resistance, tensile properties, leakage of fluids and air, water flow rate and security of connectors.
Extent of Recognition
Complete standard
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FDA recognition of CEN EN 1615:2000 [Rec# 9-95] and CEN EN 1618:1997 [Rec# 9-113] will be superseded by recognition of ISO 20695 First edition 2020-03 [Rec# 9-138].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 Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tube, Nasogastric Class 2 BSS
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
Relevant FDA Guidance and/or Supportive Publications*
Safety Considerations for 510(k) Submissions 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.

Reducing Risks through Standards Development for Medical Device Connectors: https://www.fda.gov/medical-devices/medical-device-connectors/reducing-risks-through-standards-development-medical-device-connectors

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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