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: Such requirements are given in particular International Standards for specific medical devices or accessories. A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series However, a number of steps that would improve the current situation and lead to greater patient safety can be taken.

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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 isp will be developed under future parts of the ISO series.

These healthcare fields include, but are not limited to: But mix-ups 08369 connectors that mean the wrong product is delivered can have catastrophic consequences. Top Gage Crib Worldwide, Inc. This document does not 8369 requirements for the medical devices or accessories that use these small-bore connectors.

Connectors for limb cuff inflation applications – Part 6: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. You may find similar items within these categories by selecting from the choices below:.

ISO 80369 Series – Small-bore connectors

Connectors for breathing systems and driving gases applications – Part 3: Monday to Friday – To purchase a copy visit an Authorized Reseller. It is understood that small-bore 800369 systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.

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This data is provided for general information only. Accept and continue Learn more about the cookies we use and how to change your settings. It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Live Chat Powered by jivochat. 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 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.

ISO Small-bore Connectors in Healthcare Applications

If accuracy is critical, base your final decisions on the data provided in the root document: You may be interested in: Simply stated this means that a single fault should not result in an unacceptable risk.

Proof sent to secretariat or FDIS ballot initiated: Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards.

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. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.

ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: 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. Therefore it is not surprising that misconnections are made. Small-bore connectors as specified in this International Standard are non-interconnectable with: Final text received or FDIS registered for formal approval.

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It does not specify requirements for the medical devices or accessories that use these small-bore connectors.

BS EN ISO 80369-1:2010

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 or accessories intended for use with a patient. Find Similar Items This product falls into the following categories. Is Replaced By: Connectors for urethral and urinary applications – Part 5: This principle is embodied in the requirements of numerous medical device 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. Search all products by. This International Standard also specifies the healthcare fields in which these small-bore connectors are intended to be used.

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

ISO Series – Small-bore connectors

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. In addition, new jso of small-bore connectors should be developed for other applications, and these should be non-interconnectable with Luer connectors and each other.

Final text received or FDIS registered for formal approval. ISO consists of 83069 following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Check out our FAQs.

Connectors for neuraxial applications – Part 7: Monday to Friday –