Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Current Directions in Biomedical Engineering

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Buzug, Thorsten M. / Haueisen, Jens / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Kraft, Marc / Lenarz, Thomas / Leonhardt, Steffen / Malberg, Hagen / Penzel, Thomas / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Urban, Gerald A.

CiteScore 2018: 0.47

Source Normalized Impact per Paper (SNIP) 2018: 0.377

Open Access
See all formats and pricing
More options …

Distinguishability and identifiability of products with small bore connectors according to ISO DIS 80369 series: risk analysis and summative evaluation

Elisabeth Ibenthal / Uvo M. Hölscher / Claus Backhaus
Published Online: 2017-09-07 | DOI: https://doi.org/10.1515/cdbme-2017-0106


The ISO 80369-series replace Luer-connectors in five application areas to fight misconnections. Although the standard avoids the mechanical problem of misconnections, the design of products and packages remains arbitrary. So, packages and products with same functions but different connectors could have similar designs and hence could be mixed-up.

To ascertain whether standardization is needed for marking non-distinguishable products and packages, a risk management and usability engineering process were carried out, partly.

The ensuing risk analysis created nine unacceptable risks relating to non-distinguishable packages and lookalike-products. Based on this, risk control (standardization) is needed for lookalikes with the following proposed measures: colour allocation and haptic textures for products, colour allocation and symbols for packages. Furthermore, three scenarios were planned for summative evaluation.

An additional consideration of the efficiency of proposed combinations of measures and products relying on measures would be helpful.

Keywords: Small Bore Connectors; SBC; ISO 80369; risk analysis; summative evaluation

About the article

Published Online: 2017-09-07

Citation Information: Current Directions in Biomedical Engineering, Volume 3, Issue 2, Pages 505–507, ISSN (Online) 2364-5504, DOI: https://doi.org/10.1515/cdbme-2017-0106.

Export Citation

©2017 Elisabeth Ibenthal et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. BY-NC-ND 4.0

Comments (0)

Please log in or register to comment.
Log in