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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 056 Date of Entry 06/07/2021 
FR Recognition Number 9-138
Standard
ISO  20695 First edition 2020-03
Enteral feeding systems - Design and testing
Scope/Abstract
This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories.

This document is not applicable to oral syringes.
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.
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FDA recognition of CEN EN 1615:2000 [Rec# 9-95] and CEN EN 1618:1997 [Rec# 9-113] will be superseded by recognition of ISO 20695 First edition 2020-03 [Rec# 9-138].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, Nasogastric Class 2 BSS
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Enteral Specific Transition Connectors Class 2 PIO
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.

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
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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