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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Proof sent to secretariat or FDIS ballot initiated: 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.
Accept and continue Learn more about the cookies we use and how to change your settings. These healthcare fields include, but are not limited to: Therefore 11 is not surprising that misconnections are made.
BS EN ISO 80369-1:2010
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Live Chat Powered by jivochat. 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.
To purchase a copy visit an Authorized Reseller. This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. Life cycle A standard is reviewed every 5 years 00 Preliminary. A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series 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.
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ISO Series – Small-bore connectors
Gage Crib Worldwide, Inc. Life cycle A standard is reviewed every 5 years 00 Preliminary.
Connectors for enteral applications – Part 4: Take the smart route to manage medical device compliance. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: 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.
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 Small-bore Connectors in Healthcare Applications
ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These healthcare fields of use include, but are not limited to, applications for: This document provides the methodology isi 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.
July Replaced By: Such requirements are given in particular International Standards for specific medical devices or accessories. These small-bore connectors are used in medical devices or accessories intended for use with a patient.