ISO 80369 FAQs
In the 1990s, concern grew as increasing numbers of misconnections using Luer connectors were reported. In response, the International Organization for Standardization (ISO) introduced ISO 80369 which consists of eight parts with one part (ISO 80369-1) addressing general requirements, six parts (ISO 80369-2 through -7) addressing specific applications and one part (ISO 80369-20) addressing general test methods.
On October 14, 2016, ISO formally published ISO 80369 Part 7 as the replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The impact of the changes to the medical device industry have begun to sink in and momentum has been steadily building as designers are adopting the changes to meet the upcoming deadline to conform to the new standard.
As with every new standard, there are certain changes that are much more impactful than the rest and generate the bulk of the questions that come up in the course of testing. Please fill out the form below to download your copy of the responses to the most common questions DDL receives from its customers on ISO 80369.