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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A new draft standard will go out for circulation, likely before the end of February.

Some companies may attempt to design a unique connector instead as defined in the -1 standardhowever, this connector shall not mate with the standard connectors, as yet to be approved, for the other markets. Blood Pressure Limb Cuff Inflation There continues to be three connector sets in the standard, as described previously. ISO specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO series.

The full joint working group will need to meet and determine how to implement these new standards, taking into account that luer connections are in thousands of different products throughout the world. This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. It was also decided to remove the direction of flow section in the committee draft and leave the decision to the individual country’s regulatory bodies and users to define it.

These connector designs have been proposed with dimensional details, but are still in review by the committee, and are not available to the general market.

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The Draft International Standard is currently out for vote to get a consensus on the U.

ISO 80369 Small-Bore Connector Standards

A summary of the current status of the standards is listed below. Administration sets and syringes have a female connector end that fit into a male patient-access feeding tube port. Two unique connectors were proposed for the Patient connection.

The Enteral committee is seeking to have one connector design for the patient connection, but this design is not yet finalized.

Yet despite efforts on the part of FDA and other organizations to reduce misconnections through education, protocol and monitoring, the use of Luer connectors in incompatible medical delivery systems continues to create situations where dangerous misconnections can, and do, 800369.

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 ios 3 Penn Center West, Suite PittsburghPA Nordson Medical is manufacturing prototype connectors for functional testing to the standard.

Use of these connectors for other applications increases risk 8036 a hazardous misconnection could occur. This standard is truly a worldwide document with representation by consultants and manufacturers in Europe, North America, Asia Pacific and South America.

ISO I Small Bore Connectors | Qosina

During the development of the ISO series it became evident that many of the test methods were very similar for each of the applications. Got a Question, an Idea, a Challenge?

Catalog Search Website Search. Neuraxial Devices Neuraxial connector design has been determined.

Enteral Feeding To improve on the committees progress, attendees to the committee meeting were narrowed to a few delegates from each region of the world. This will most likely be led and completed by the 83069.

What Is ISO 80369-6:2016?

The major outcome of this meeting was that the initial Part 1 document ISODIS was completed and will be sent out for vote in the next couple of months.


In addition, a committee has been formed and is meeting to analyze the potential interconnections between the proposed connectors in each committee standard. This standard is now expected to be released in late The standard is expected to release in Monday to Friday – But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences.

Do you accept cookies and the implication associated with the usage of your personal data? Monday to Friday – This standard will most likely be published in They are also involved in supporting the group after the meeting.

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

The problem is well-known and well documented. Qosina is actively following ISO updates and will be adding compliant components to its extensive line as the standards evolve.

The second edition of ISO has been submitted to replace the first edition and will be up for vote.

Manufacturers may use the approved connectors, or design their own custom. ISO General Requirements and Overview ISO specifies general isi for small-bore connectors, which convey liquids or gases in healthcare applications. The development of better small-bore connections in medical care has been an ongoing patient safety initiative for over 2 decades.