What is an ISO?
To understand the challenges of the creation of the ISO 80369, you first need to know what an ISO is.
What about ISO 80369?
Patients within healthcare settings receive medication and other therapies through a variety of tubes and catheters. The connectors of these different delivery systems are often compatible and can be connected to each other.
These errors are called tubing misconnections.
- Discovery of the first patient injuries and deaths linked to tubing misconnections.
- Clinical concerns are raised and health authorities are informed.
- Vygon creates one of the first reverse-Luer safety enteral feeding system, called Nutrisafe1.
- Creation of a European working group (CEN CHeF FTG => CR 13825:2000).
- The purpose is to discuss misconnection risks and see if standards can help to address these issues
- Vygon takes part in this discussion group.
- Creation of an official Working Group in the European Standard Committee (CEN BTTF 123 “Small Bore Connectors”).
- Vygon joins this European Working Group.
- Vygon understands that a reversed-Luer can be reversed and misconnection is still possible. Vygon decides to modify Nutrisafe1 in order to be totally incompatible with Luer and compliant with neonatal requirements.
- Vygon invents the first safe non-Luer enteral feeding system designed for neonates, called Nutrisafe2.
- Transfer from European Committee to International Committee (creation of the ISO/IEC JWG 4 “Small Bore Connectors”).
- Vygon is a member of the ISO committee.
- Publication of the Part 1 “General requirements” as EN 15546-1 (named in 2010 : ISO 80639-1).
- Publication of the Part 20 “Common test methods” (ISO 80369-20).
- March: Publication of the standard specifically for the design of connectors for limb cuff inflation applications (ISO 80369-5)
- March: Publication of the standard specifically for the design of connectors for neuraxial applications (ISO 80369-6)
- July: Publication of the standard specifically for the design of connectors for enteral applications (ISO 80369-3)
- October: Publication of the standard specifically for the design of connectors for intravascular or hypodermic applications (ISO 80369-7)