Home News and Events Press Releases DDL Increases Capabilities with the Addition of ISO 80369-1 Testing

Minneapolis, MN – October 20, 2011 -- http://www.testedandproven.com/ -- DDL, industry leader in medical device package, product and material testing, announces the expansion of their testing capabilities with the addition of ISO 80369-1 testing. According to ISO, this new procedure specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

“In the early 1990’s, we saw an increase in the number of medical devices that used luer connectors,” Mark Francis, DDL’s Product & Material Lab Manager said. “Thus, concern grew as reports of patient death or injury increased as a result of misconnections in the field.”

 

 

As a response, ISO (International Organization for Standardization) introduced ISO 80369, which consists of seven parts with part one addressing the general requirements and the remaining parts addressing specific applications. The overall intent of the new standard is to reduce the risk of misconnection by creating six application specific connectors which cannot interconnect with one another.

“The timeline for the official introduction of ISO 80369- 2 through -7 has not yet been defined, however, the important thing for medical device manufactures to be aware of is the fact that ISO 80369-1 Annex B, is an FDA recognized standard and as such MDM’s will be held to this standard,” Francis said.

In an effort to keep up with current standards and further assist MDM’s in achieving the appropriate level of FDA compliance, DDL has purchased an axial/torsion testing system. With this and their experience in testing per ISO 594, DDL’s Product & Materials Division is fully prepared to test to ISO 80369-1 at this time.