ISO 80369-3:2016/Amd 1:2019 null. Saltar navegación principal UNE Español English (+34) 915 294 900 Revista Digital Contacto ISO 80369-3 February 1, 2019 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications AMENDMENT 1 A description is not available for this item. 80369-3 DAM 2. March 7, 2017 Small-bore connectors for ISO 80369-3:2016 was published in July 2016 and the Medzus Medical recognizes this standard. This standard provides specifications for connectors intended for enteral applications. ENFit is designed to ensure that feeding tube connectors are incompatible with the connectors for unrelated delivery systems such as tracheal tubes, IV lines, and other vascular catheters. NOTE 3 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for smallbore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) Newest version Valid from 16.06.2017 ISO 80369-1:2018 Product Code(s): 30287230, 30287230, 30287230 Document History. BS EN ISO 80369-1:2018 currently viewing. November 2018 Small-bore connectors for liquids and gases in healthcare applications. General requirements ISO 80369-3 – Used for connections on enteral medical devices and accessories ISO 80369-7 – Used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories Please contact us today. Our experienced engineers look forward to working with you on your Luer testing requirements. We can also develop and validate custom ISO 80369-7 defines the luer fitting and drives minor changes to the design, primarily defining additional dimensions previously undefined in the old standard, ISO 594-1 and 594-2. Luers made to the ISO 80369-7 standard will connect to luers made to the ISO 594-1 and ISO 594-2 standard, but connectors made to the old standards do not comply with the new ISO 80369-7 standard.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
What ISO 80369 means for the market It is up to the industry to decide whether it wishes to implement these standards. While ISO standards may be adopted in some countries as part of their regulatory framework, or referred to in legislation for which they serve as the technical basis, such adoptions are decisions by the regulatory authorities or governments of the countries concerned. ISO 80369-3:2016/Amd 1:2019 null. Entra en AENOR ISO has formally published 80369 Part 7, the long-awaited replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Internationale relationer : EN ISO 80369-7:2017 IDT ISO 80369-7:2016 IDT ICS: 11.040.25 - Sprøjter, kanyler og katetre Varenummer: M273464 ISO 80369-6: Neuraxial (Spinal, Epidural & Regional Anaesthesia) Connectors: Neuraxial devices, such as epidural catheters, are used to deliver medicines or anesthesia to neuraxial sites, such as the epidural space, or are used to monitor or remove cerebral-spinal fluid for therapeutic ISO 80369-3:2016/Amd 1:2019 null. Saltar navegación principal UNE Español English (+34) 915 294 900 Revista Digital Contacto
ISO/CD 80369-2 Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applications
ISO 80369-3 – Used for connections on enteral medical devices and accessories ISO 80369-7 – Used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories Please contact us today. Our experienced engineers look forward to working with you on your Luer testing requirements. We can also develop and validate custom
Setting The Standard: The Role of the New ISO 80369 Standards in Ensuring Patient Safety. Published date: 25 Apr 2019. Back to Article Listing. By complying with the new ISO 80369 standards, a component supplier can help ensure that when an individual enters a hospital or emergency room they will be provided with the correct fluids and/or gases to keep them alive. DIN EN ISO 80369-2 - 2015-09 Small bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases applications (ISO/DIS 80369-2:2015); German and English version prEN ISO 80369-2:2015. Inform now!
The ISO 80369-7 compliant barbed luers and bond-in luers will be available in sizes currently offered by Injectech. Additional sizes and custom components are welcomed. For additional information about Injectech’s ISO 80369-7 series of fittings, contact our office at …
ISO 80369-7 contains both requirements within the same document, but is still not explicit about when one should invoke the tests against both slip and lock reference connectors. This is an important consideration when qualifying a female locking Luer, as both male slip and locking Luers