ISO 80369 1 PDF

Published by on February 28, 2020
Categories: Life

Partie 1: Exigences générales. STANDARD. ISO. Second edition. Reference number. ISO (E). Provläsningsexemplar / Preview. ISO contains the following major technical revisions to the previous ISO and ISO standards: The addition of new terms. The culmination of their work, ISO , was published in January The sweeping standard provides general connector requirements.

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Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery systems were raised, ido it was concluded that there is a problem arising from the use of a single connector design to a number of incompatible applications.

Small-bore connectors as specified in this International Standard are non-interconnectable with: This document does not specify requirements for the medical devices or accessories that use these small-bore connectors.

ISO 80369 Series – Small-bore connectors

ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Fluids handling equipment medicalPipe connections, Safety measures, Medical breathing apparatus, Small, Medical equipment, Parenteral infusion equipment, Blood transfusion equipment, Gases, Risk assessment, Catheters, Liquids, Drug administration, Conical fittings syringes.

Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives. Connectors for urethral and urinary applications – Part 5: Extending this principle to the application of Luer connectors, i.


This principle is embodied in the requirements of numerous medical device standards. Gage Crib Worldwide, Inc. Subsequent parts of this series of standards are expected to include requirements with regard to iwo connectors used in different application categories.

The faster, easier way to work with standards. ISO Introduction In the s concern grew regarding the proliferation of medical devices fitted with Luer connectors and the reports of patient death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.

Simply stated this means that a single fault should not result in an unacceptable risk.

ISO Series – Small-bore connectors

Your basket is empty. This will only be achieved through 8069 long-term commitment involving industry, healthcare professionals, izo device purchasers and medical device regulatory authorities. Such requirements are given in particular International Standards for specific medical devices or accessories. Click to learn more. This standard has been revised by ISO This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications.

Take the smart route to manage medical device compliance. By Clare Naden on 20 October ISO Scope Notes – NOTE 1 It is intended that new designs of small-bore connectors will be included in this series of standards after they have been assessed according to the procedure given in Clause 6.


Check out our FAQs. These healthcare fields of use include, but are not limited to, applications for: Connectors for limb cuff inflation applications – Part 6: Final text received or FDIS registered for formal approval. Small-bore connectors as specified in ISO Use of these connectors for other applications increases risk that a hazardous misconnection could occur. ISO Foreword Isi part 1 of this International Standard ido general requirements to ensure the prevention of misconnection between small-bore connectors used in different applications.

It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors as specified in the series of standards will be included.

ISO Small-bore Connectors in Healthcare Applications

This data is provided for general information only. Find Similar Items This product falls into the following categories. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. You may experience issues viewing this site in Internet Explorer 9, 10 or