ISO Standards on enteral feeding systems

"ISO 20695: Enteral feeding systems — Design and testing"

Current title of ISO/DIS 20695:2017

The aim of ISO 20695 is to revise the existing EN 1615/EN 1618* standards, to convert these two European standards into one international standard and to incorporate the requirements of ISO 80369 (Part 1 and 3).

This ISO 20695 standard is under development within the CEN/TC205 /WG16 group. Vygon is one of the expert members of this working group.

The first draft of ISO 20695 was disapproved at the international level in its September 2017 vote.

One of the main reasons is that the so-called “Low Dose Tip” (LDT) syringe had been incorporated into the ISO 20695 standard while its ability to reliably:

  • Bench-top operations have shown that an overdose is clearly possible if fluid is present in the hub of the LDT syringe.
  • Numerical simulations (taking into account physical parameters such as gravity, viscosity, rotational speed, etc.) have shown that this overdose was 0.120 ml, which is roughly equivalent to the conventional ENFit syringe.

A new draft of ISO 20695 is under development. The main changes made will be:

  • Removal of the LDT syringe from the prescriptive requirements (The design of the LDT syringe will only be presented for information purposes so that manufacturers who wish to manufacture it may have the right dimensions).
  • Deletion of the term “Low Dose Tip” since this syringe has not been proven to increase dosage accuracy compared to ENFit. (This syringe will be called “alternative design of enteral syringe nozzle”).

 

*NOTE:

  • EN 1615: 2000 "Enteral feeding catheters and enteral giving sets for single use and their connectors – Design and testing"
  • EN 1618: 1997 "Catheters other than intravascular catheters – Test methods for common properties”