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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But mix-ups with connectors that mean the wrong product oso delivered can have catastrophic consequences. This uso specifies requirements for small-bore connectors intended to be used in neuraxial applications. Toward this end much discussion took place regarding which dimensions are controlled by the standard and which are not. What is ISOand How Does It Affect You Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems.

ISO 80369 Standards Compliant Parts

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.

The CAD experts are utilizing a macro driven spreadsheet to conduct initial kso for misconnections followed by detailed 3D analysis of possible misconnections. Contact us to schedule an appointment with our knowledgeable staff.

CAD Group Meeting 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.


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 out for the next review. Urinary and Urethral No specific updates at this time. Two initial connector sets are proposed.

ISO I Small Bore Connectors | Qosina

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, occur.

This standard has been revised by ISO Check out our FAQs. There was significant discussion about the two connector sets: ISO is a new standard that is being developed by the International Organization for Standardization to improve patient safety and reduce the risk of small-bore misconnections used in liquid and gas healthcare applications.

Until connectors are defined and approved for each market, no definitive action can be taken. Established a task group to develop an implementation guide for the transition. The standards for these markets will be provided in separate ISO documents numbered from -2 to NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards.

California law AB states: The new standard has changed the configuration of the male and female connectors. Please view our line of ISO components.

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. This may not be enough time. The law passed in California isi there ieo only about 2 years left for Enteral and Neuraxial to get their connector standards approved and products incorporating these connectors completed. A small-bore connector is defined as having an ID of less than 8.


The performance requirements were reviewed to make sure that these requirements are correct. To know more about cookies and treatment of your personal data, please consult our policy on confidentiality by clicking on “To know more”.

See details below, with regards to the progress in each market standard. 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 Nordson Medical is involved in these committee meetings and ieo been given permission to share updates.

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

The California experience is expected to serve as a catalyst for the transition to the new standard and greatly hasten its widespread adoption. A few minor changes will be made. Under guidance from the committee, functional testing will take place in the June-July timeframe.

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. It is expected that all existing ISO connectors will meet the requirements of ISO byand that when testing or validation occurs, it is made using the requirements of ISO