April 5, 2020

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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ISO 80369 Small-Bore Connector Standards

This standard is truly a worldwide document with representation by consultants and manufacturers in Europe, North America, Asia Pacific and South America. The second edition of ISO has been submitted to replace the first edition and will be up for vote.

The document is broken down into the following sections: Below is an update on the ISO initiative for medical device small bore connectors. Final text received or FDIS registered for formal approval.

Life cycle A standard is reviewed every 5 years 00 Preliminary. A new draft standard will go out for circulation, likely before the end of February. This has already been conducted for -3 by a private usability group and for -5 and -7 from a historical use perspective. Urinary and Urethral No updates at this time.

It was the feeling of the standards committee that all three connections will be a part of the standard, and manufacturers may then choose which one they want to use in their products. ISO General Requirements and Overview ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. What does Qosina offer to help you comply with ISO Qosina offers an extensive line of enteral feeding connectors that have been isi to meet the ISO standard.


What Is ISO 80369-6:2016?

Additional fees may be required based on volume. California law AB states: That an oversight committee comprised of PG leaders be appointed to review high level issues that may arise and that they create an implementation guide. The CAD experts for each committee continue to meet and evaluate proposed connector designs to ensure that the proposed designs do not mate with luers, and will not mate with proposed designs from other standards committees.

A revised standard is in circulation with comments due by February Small-bore connections defined as having an inner diameter less than 8. Qosina stocks a number of ISO compliant components including connectors, stopcocks, hemostasis valves and check valves.

ISO I Small Bore Connectors | Qosina

They are also involved in supporting the group after the meeting. Technical Information Applications Online Store. It is recognized by the standards committee 803669 the new law in California, goes into effectwhich states that luers may not be used in enteral feeding applications in the state.

The standard is expected to release in December, Update The ISO working group met in London in December, to discuss each specification, and work toward the next level to release these specifications for review.

This standard has been revised by ISO Life cycle A standard is reviewed every 5 years 00 Preliminary. A new draft standard will go out for circulation, within the next two months. Discussions have been isp concerning the definition of Small Bore and any limitations to connector sizes. Here is a summary of the meeting: A human factors study to verify appropriate usability is to be conducted.


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However, some regulatory agencies may evaluate future connector designs in specified markets as to whether the design interconnects with a luer. Final revisions are being made to the standard and drawings of the connectors proposed. At the end of the week, the joint working group members met again to review progress and discuss next steps. The document is broken down into the following sections:.

Urinary and Urethral This application category will not be addressed at this time. Small-bore connectors for liquids and gases in healthcare isl Title of ISO Specific standards for connectors in markets listed in have not been completed. Connectors for intravascular or hypodermic applications.

The desire of the committee is to narrow the options to one unique connector, but two connector sets may remain in the standards document when it is sent uso for the next review. Please view our line of ISO components.