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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General Notes A CAD computer aided drafting tool has been developed to verify conformance to the small bore connector standard, accommodating for least material condition LMC and maximum material condition MMC. A new standard for connectors with intravenous or iwo applications has just been published, complementing the series Here is a summary of the meeting:.

Common Test Methods This is to be completed for all connectors. Two initial connector sets are proposed. Respiratory Breathing Systems The committee facilitated the creation of a task sub group which will be trusted with building tools, molding connectors and completing the functional tests as per ISO This standard is expected to be released in late or early No physical changes to the current luer io are anticipated.

Blood Pressure Limb Cuff Inflation There continues to be three connector sets in the standard, as described previously. Patients often have multiple lines connected to them to deliver medicine and nutrients. It was discovered that in certain situations the parts could misconnect with luers. However, some regulatory agencies may evaluate future connector designs in specified markets as to whether the design interconnects with a luer.

What Is ISO 80369-6:2016?

Until connectors are defined and approved for each market, no definitive action can be taken. The California experience is expected to serve as a catalyst for the transition to the new standard and greatly hasten its widespread adoption. Currently, all parts will require the testing of physical part samples per the standard to validate conformance.


Such errors have occurred in diverse clinical settings, causing serious patient injuries and deaths. Functional testing of parts conforming to the CAD designs is in progress.

Respiratory Breathing Systems The task group now comprises of many global players from the industry including Philips, Smiths Medical, Draeger, CareFusion, Covidien, and CR Bard Connector functional testing to standard will commence in February, Task group to look into dead volume concerns of existing connector designs DIS draft is in progress Next steps are to develop a representative usability test protocol Standard is expected to release between October, and March, ISO Adaptors will not be manufactured, and syringes will need to have an application-specific connector.

The PG2 Respiratory standards committee did not meet. However, since the color yellow has not uncommonly been used to indicate a neuraxial route, it appears that some manufacturers may incorporate yellow into NRFit compatible equipment. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

ISO I Small Bore Connectors | Qosina

The common current practice of using Luer connection syringes to inject through neuraxial and major regional catheters will no longer be possible. We are closely monitoring updates to this standard and adding new products on a regular basis.

International Organization for Standardization: In response to the need to create safer standard medical connections, the ISO formed a working group representing 31 countries. Timeline for release TBD pending validation and next steps.

Connectors for the delivery of nutrients through feeding tubes.

ISO 80369 Small-Bore Connector Standards

To further reduce the occurrence of these misconnections, FDA is actively participating in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors. It will be important to evaluate these new connectors in each standard to make sure that device performance 803669 usability are not compromised in a real clinical setting. Qosina offers an extensive line of enteral feeding connectors that have been designed to meet the ISO is.


These documents are still in process and are being actively developed by separate committees.

This will most likely be led and completed by the FDA. You may be interested in: Once implemented, these connectors will facilitate correct connections and eliminate incompatible tubing misconnections.

These applications involve the use of medical devices used to administer medications to neuraxial sites, wound infiltration anesthesia delivery and other regional anesthesia procedures, or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic sio.

They also provide a locking feature that signals the appropriate lso and stays in place. Usability testing needs to be completed by each committee before the connectors in the standard can be finalized. This has already been conducted for -3 by a private usability group and for -5 and -7 from a historical use perspective.

The new standard has changed the configuration of the male and female connectors.

Established a task group to develop an implementation guide for the transition. There continues to be three connector sets in the standard, as described previously.

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. The new standards are intended to eliminate the possibility of injections between Luer and NRFit systems.