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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But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences.
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ISO Small-bore Connectors in Healthcare Applications
Small-bore connectors as specified in this International Standard are non-interconnectable with: These small-bore connectors are used in medical devices or accessories intended for use with a patient. Gage Crib Worldwide, Inc. Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives.
Click to learn more. 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.
Small-bore connectors as specified in ISO Final text received or FDIS registered for formal approval. It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.
These small-bore connectors are used in medical devices or accessories intended for use with a patient. Please download Chrome or Firefox or view our browser tips. Concerns regarding 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.
ISO 80369 Series – Small-bore connectors
Extending this principle to the application of Luer connectors, i. You may be interested in: Such requirements are given in particular International Standards for specific medical devices ieo accessories. By Clare Naden on 20 October Therefore it is not surprising that misconnections are made.
The intention is to provide accurate information; regardless; errors may exist in the supplied information. It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Monday to Friday – ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: These healthcare fields include, but are not limited to: This document 8039 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 80396 of the ISO series.
This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical 11 purchasers and medical device regulatory authorities. This data is provided for general information only. Check out our FAQs. Take the smart route to manage medical device compliance. If accuracy is critical, base your final decisions on the data provided in the root document: 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.
July Replaced By: This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. This standard has been revised by ISO Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories.
Such requirements are given in particular International Standards for specific medical devices or accessories. Connectors for enteral applications – Part 4: Top Gage Crib Worldwide, Inc.
The faster, easier way to work with standards. 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.
Your basket is empty. These healthcare fields of use include, but are not limited to, applications for: These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.
Connectors for neuraxial applications – Part 7: Fluids handling equipment medicalPipe connections, Safety measures, Medical breathing apparatus, Small, Medical equipment, Ixo infusion equipment, Blood transfusion equipment, Gases, Risk assessment, Catheters, Liquids, Drug administration, Conical fittings syringes.