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.
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.