The Japanese principle of “poka-yoke”, or passive mistake-proofing, is a key principle of product design in many industries. The goal is simply to remove product defects by preventing human errors on the front end of a process, correcting them during the process, or drawing attention to them after a process is completed, to reduce the chance of part failure, insufficient performance, or most importantly user/operator safety. It is in this spirit that the ISO 80369 standard was written.
Thestandard incorporates design modifications, improvements and/or clarifies validation steps needed to medical facility situations. This study, take human error out of stressful focused on three medical device applications of ISO and solutions that 80369, provides practical insight into the challenges device designers can implement to ensure their products are standard-compliant.
For ISO 80369-3 (connectors for enteral applications), this paper lists the modulus of elasticity in two force directions, and it addresses a critical counterpoint regarding flow rate with the smaller nozzle aperture. For ISO 80369-6 (connectors for neuraxial device applications), this white paper describes geometric differences of the new fitting, and it addresses how end users can ensure that joining connectors from different manufacturers will interface properly. ISO 80369-7 (connectors for intravascular or hypodermic applications) describes nuances of the section of the standard specific to some of the most commonly misconnected device types, and designates what steps are needed for new or existing products to confirm or achieve compliance.