CEN EN 1615:2000

Standard Organization:

CEN EN 1615:2000
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing

Recognition Date2014-10-17
Recognition List037
Recognition Number9-95
Extent 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
Standards Orgs CEN European Committee for Standardization https://www.cen.eu
STG ObGyn/Gastroenterology/Urology
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Rationale:

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.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT

FDA Guidance:

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.

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