ISO 80369 1 PDF

ISO 80369 1 PDF

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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This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities. Monday to Friday – These small-bore connectors are used in medical devices or accessories intended for use with a patient.

A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series It does not specify requirements for the medical devices or accessories that use these small-bore connectors. You may be interested in: ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Extending this principle to the application of Luer connectors, i.

Accept and continue Learn more about the cookies we use and how to change your settings. However, a number of steps that would improve the current situation and lead to greater patient safety can be taken.

Therefore it is not surprising that misconnections are made. Final text received or FDIS registered for formal approval. ISO Foreword This part 1 of this International Standard contains general requirements to ensure is prevention of misconnection between small-bore connectors used in different applications.

BS EN ISO 80369-1:2010

The intention is to provide accurate information; regardless; errors may exist in the supplied information. These healthcare fields of use include, but are not limited to, applications for: It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. It does not specify requirements for the medical devices or accessories that use these small-bore connectors.

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Connectors for breathing systems and driving gases applications – Part 3: Click to learn more. Connectors for urethral and urinary applications – Part 5: July Replaced By: Top Gage Crib Worldwide, Inc. These small-bore connectors are used in medical devices or accessories intended for use with a patient. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO series of standards will be considered.

ISO 80369 Series – Small-bore connectors

kso This data is provided for general information only. Such requirements are given in particular International Standards for specific medical devices or accessories. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

By Clare Naden on 20 October To purchase a copy visit an Authorized Reseller. The faster, easier way to work with standards.

Such requirements are given in particular International Standards for specific medical devices or accessories. 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.

Your basket is empty. ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. This standard has been revised by ISO Monday to Friday – These healthcare fields include, but are not limited to: This series of standards is being developed in such a way that ISO includes general requirements to prevent misconnections between small-bore connectors used in different applications.

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Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.

ISO Small-bore Connectors in Healthcare Applications

Connectors for enteral applications – Part 4: Learn more about the cookies we use and how to change your settings. Check out our FAQs.

This International Standard also specifies the healthcare fields in is these small-bore connectors are intended to be used. Concerns 80639 the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery systems were raised, and it was concluded that there is a problem arising from the use of a single connector design to a number of incompatible applications.

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.