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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Connectors for neuraxial applications – Part 7: Your basket is empty. Search all products by. The faster, easier way to work with standards.

Small-bore connectors as specified in ISO You may find similar items within these categories by selecting iiso the choices below:. Learn more about the cookies we use and how to change your settings. 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.

Take the smart route to manage medical device compliance. This data is provided for general information only. Small-bore connectors as specified in this International Standard are non-interconnectable with: You may be interested in: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

The intention is to 8039 accurate information; regardless; errors may exist in the supplied information.

Extending this principle to the application of Luer connectors, i. Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories.

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Find Similar Items This product falls into the following categories. To purchase a copy visit an Authorized Reseller. It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.

You may experience issues viewing this site in Internet Explorer 9, 10 or Such requirements are given in particular International Standards for specific medical devices or accessories.

Use of these connectors for other applications increases risk that 11 hazardous misconnection could occur. Life cycle A standard is reviewed every 5 years 00 Preliminary. ISO Foreword This part 1 of this International Standard contains general requirements to ensure the prevention of misconnection between small-bore connectors used in different applications.

BS EN ISO 80369-1:2010

But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. Monday to Friday – This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and 08369 device regulatory authorities. Top Gage Crib Worldwide, Inc. By Clare Naden on 20 October It does not specify requirements for the medical devices or accessories that use these small-bore connectors.

In addition, new designs of small-bore connectors should be developed for other applications, and these should be non-interconnectable with Luer connectors and each other. Proof sent to secretariat or FDIS ballot initiated: Please download Chrome or Firefox or view our browser tips. 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.


ISO Small-bore Connectors in Healthcare Applications

This standard has been revised by ISO Final text received or FDIS registered for formal approval. Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives. Connectors for limb cuff jso applications – Part 6: A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series Check out our FAQs.

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

ISO 80369 Series – Small-bore connectors

Final text received or FDIS registered for formal approval. Part 1 of this International Standard and its parts are intended to 8369 the reference documents in which the necessary measures and procedures to prevent misconnection between small-bore connectors used in different applications and designs of small-bore connectors for applications are listed. Live Chat Powered by jivochat. If accuracy is critical, base your final decisions on the data provided in the root document: However, a number of steps that would improve the current situation and lead to greater patient safety can be taken.