ISO 80369-7 Foreword
ISO 80369-7 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised.
ISO 80369-7 Introduction
ISO 80369-7 includes the dimensions and drawings of connectors intended to be used as conical fittings with a 6 % Luer taper for connections in intravascular or hypodermic applications of medical devices and accessories. ISO 80369-7 contains the following major technical revisions to the previous ISO 594-1 and ISO 594-2 standards: - New terms and definitions have been added to ISO 80369-7 to more clearly define the various types of Luer connectors included in the scope of this standard. ISO 80369-7 more broadly describes the requirements for the connectors used for intravascular or hypodermic applications, unlike the previous ISO 594-1 and ISO 594-2 standards that are replaced by this standard, which only described the requirements for the fittings (intended connection surfaces) of these connectors. This distinction is important to define here because the previous standards do not contain the terms ‘connectors’ or ‘connection’ and the ISO 80369 family of standards does not use the term ‘fitting’. - Requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 are added to this standard to reduce the risk of misconnections between medical devices or accessories for different applications with the small-bore connectors that are being developed under other parts of the ISO 80369 series of standards. These new dimensions were selected to represent the current design and dimensions of Luer connectors in clinical use at the time this standard was developed. The term ‘6 % Luer taper’ used throughout the previous standards has also been clarified to the more commonly used equivalent angular dimension (in degrees). - Requirements for gauging of Luer connectors made from semi-rigid materials using plug and ring test gauges have been replaced by dimensional requirements, which are more precise and essential for reducing the risk of misconnection with the other connectors identified in ISO 80369-1. - Separate requirements for Luer connectors made from semi-rigid materials and rigid materials have been eliminated and combined as one common set of dimensions and requirements. This consolidation of requirements was made to further reduce the risk of misconnection with other small-bore connectors.
ISO 80369-7 Scope
ISO 80369-7 specifies requirements for small-bore connectors intended to be used as intravascular connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and related accessories. ISO 80369-7 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. ISO 80369-7 does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Hypodermic use includes percutaneous infusion and injection as well as pressurizing and depressurizing inflation cuffs used to hold invasive medical devices in place. ISO 80369-7 does not specify requirements for the following connectors which are specified in other standards:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637 and applicable portion 217 of ISO 8638 referencing blood compartment ports]
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors [ISO 8637]
- infusion system closure piercing connectors [ISO 8536-4]
ISO 80369-7 Reference Fittings
ISO 80369-7 specifies the Reference Fittings to be use to functionally testing these connectors. The test methodology is defined in ISO 80369-20. We also offer extra-specification ISO 80369-7 Gages to test the physical attributes of the ISO 80369-7 Connectors.
This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root document: ISO80369-7:2016; which is a copyrighted document. To purchase a copy visit an Authorized Reseller.
Original Posting: 8/28/2014
Last Revision: 12/11/2016
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