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ISO Info

10 items

  • Benefits of ISO Standardization to the ENFit® Enteral Feeding Connector

    Benefits of ISO Standardization to the ENFit® Enteral Feeding Connector

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  • Benefits of ISO Standardization to the ENFit® Enteral Feeding Connector

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  • A Conversation with the FDA on Irrigation Bag Connections

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  • Managing risk during transition to new ISO tubing connector standards

    Tubing misconnections continue to cause severe patient injury and death, since tubes with different functions can easily be connected using luer connectors, or connections can be “rigged” (constructed) using adapters, tubing or catheters. This is why new ISO (International Organization for Standardization) tubing connector standards are being developed for manufacturers.

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  • ISO80369 White Paper ISO Guideline

    ISO80369 White Paper ISO Guideline for the implementation of medical products using small bore connectors specified in the ISO-80369 series

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  • GEDSA ENFit Distributor GPO and Supply Chain Update

    GEDSA Guidance to Distributors, GPOs, & Supply Chain Representatives on Adoption of ISO 80369-3 Enteral Feeding Device ENFit™ Connectors

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  • FDA Misconnections Letter

    Subject Line: The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury Dear Colleagues, The U.S. Food and Drug Administration (FDA) is concerned by continued reports of misconnections with enteral devices. To reduce the risk of misconnections and patient injury, the FDA recommends hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that meet the 80369-3 standards, many of which are identified by the tradename ENFit.

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  • Calculating ISO 7886 TOGC 1 5 10ml

    This paper shows the method for using table 1 in ISO 7886-1 to calculate the Tolerance on graduated capacity (TOGC) for syringes, and displays calculated values for different combinations of syringe size (1, 5 and 10ml) and expelled volume. It is available online as a pdf.

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  • A Conversation with the FDA on Irrigation bag Connections Final

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  • GEDSA and ISO 80369 6 Position Statement FW

    November 2016: GEDSA Position Statement in support of ISO 80369-6 To reduce the risk of wrong route delivery of fluids and gases (tubing misconnections) there is an ongoing effort led by the International Organization for Standardization (ISO) to address smallbore connectors for healthcare applications.

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