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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These healthcare fields of use include, but are not limited to, applications for: Use of these connectors for other applications increases risk that a hazardous misconnection could occur. Such requirements are given in particular International Standards for uso medical devices or accessories.

Small-bore connectors as specified in ISO 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.

BS EN ISO 80369-1:2010

Such requirements are given in particular International Standards for specific medical devices or accessories. Such requirements are given in particular International Standards for specific medical devices or accessories. But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. Accept and continue Learn more about the cookies we use and how to change your settings. 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.

Take the smart route to manage medical device compliance.

Find Similar Items This product falls into the following categories. 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. You may find similar items within these categories by selecting from the choices below:. We use cookies to make our website easier to use and to better understand your needs. These healthcare fields of use include, but are not limited to, applications for: This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.

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ISO 80369 Series – Small-bore connectors

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This data is provided for general information only. ISO Introduction In the s concern grew regarding the proliferation of medical devices fitted with Luer connectors and the reports of sio death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.

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These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient. These healthcare fields 8069, but are not limited to: Fluids is 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.

If accuracy is critical, base your final decisions on the data provided in the root document: Please download Chrome or Firefox or view our browser tips.

ISO Small-bore Connectors in Healthcare Applications

Connectors for breathing systems and driving gases applications – Part 3: 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. Click to learn more. Final text received or FDIS registered for formal approval. The faster, easier way to work with standards.

Learn more about the cookies we use and how to change your settings. ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Connectors for urethral and urinary applications – Part 5: You may experience issues viewing this site in Internet Explorer 9, 10 or 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.

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Part 1 of this International Standard and its parts are intended to be 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.

This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.

ISO Series – Small-bore connectors

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 series.

However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives.

Life cycle A standard is reviewed every 5 years 00 Preliminary. Small-bore connectors as specified in this International Standard are non-interconnectable with: ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: Check out our FAQs.

By Clare Naden on 20 October It does not specify requirements for the medical devices or accessories that use these small-bore connectors. The intention is to provide accurate information; regardless; errors may exist in the supplied information.

Extending this principle to the application of Luer connectors, i.