ISO 80369 PDF

To learn about ISO and small bore connector standards, visit our website for ISO standard information and shop our products today. ISO is the newly published standard that replaces the ISO series of standards. The ‘Part 7’ standard is specifically for small-bore. intravasculaires ou hypodermiques. STANDARD. ISO. First edition. Reference number. ISO (E). Corrected version.

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What Is ISO ? – American Society of Regional Anesthesia and Pain Medicine

Small-bore connections defined as having an inner diameter less than 8. From the manufacturing, compatibility, and ease-of-use standpoints, it is obviously desirable to standardize such connections. A formative step in the standardization of small-bore connections occurred when Hermann Luer of Paris, France, filed a patent for a precise syringe design with the United States Patent Office in This design provides a secure and reliable small-bore connection that is easy to attach and detach.

The Luer connection has emerged as the industry leader and has been extensively used for intravascular, neuraxial, enteral, medical gas, and monitoring applications.

In this regard, reports can be found for the inadvertent neuraxial administration of virtually any drug intended for intravenous administration with sometimes catastrophic consequences, as in the case of tranexamic acid. In response to the need to create safer standard medical connections, the ISO formed a 8036 group representing 31 countries.


The familiar Luer connection will continue to be used and dedicated to intravascular and hypodermic applications ISOwith new connections developed for the other applications.

There is no formal timeline for transition from Luer to NRFit connections. However, NRFit connections are now commercially available and as of January 1,their use will be mandated in the state of California. California law AB states: Commencing January 1,a health facility, as defined in subdivision abcor f of Sectionis prohibited from using an epidural connector that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

The California experience is expected to serve as a catalyst for the transition to the new standard and greatly hasten its widespread adoption. The new standards are intended to eliminate the possibility of injections isk Luer and NRFit systems. The common current practice of using Luer connection syringes to inject through neuraxial and major regional catheters will no longer be possible.

ISO 80369 Small-Bore Connector Standards

Adaptors will not be 8036, and syringes will need to have an application-specific connector. Along these lines, it should be noted that features that would help readily distinguish NRFit from Luer syringes, such as coloration and packaging, will be at the discretion of the manufacturer.

However, since the color yellow has not uncommonly been used to indicate a neuraxial route, it appears that some manufacturers may 08369 yellow into NRFit compatible equipment. The development of new standards naturally raises a number of questions from practitioners. An excellent place to learn more about the introduction of these new medical connections is the Stay Connected Web site.


Facts regarding neuraxial-specific connectors can be accessed at: The development of 80396 small-bore connections in medical care has been an ongoing patient safety initiative for over 2 decades. Now that new standards for neuraxial and major regional anesthesia have been developed and the redesigned products are reaching the market, it is anticipated that isk will be rapidly adopted into clinical use.

Practitioners are advised to familiarize themselves with this new development in regional anesthesia.

ISO I Small Bore Connectors | Qosina

What Is ISO American Society of Regional Anesthesia and Pain Medicine Advancing the science and practice of regional anesthesiology and pain medicine to improve patient outcomes through research, education, and advocacy 3 Penn Center West, Suite PittsburghPA About Calendar Patient information Corporate partners Donate.

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