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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Extending this principle to the application of Luer connectors, i. This document specifies general requirements for small-bore connectors, which convey ieo or gases in healthcare applications. Search all products by.
It does not specify requirements for the medical devices or accessories that use 80639 small-bore connectors. ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Monday to Friday – Monday to Friday – This data is provided for general information only.
Click to learn more. Small-bore connectors as specified in this International Standard are non-interconnectable with: In addition, new designs of small-bore connectors should be developed for other applications, and these should be non-interconnectable with 80396 connectors and each other.
ISO 80369 Series – Small-bore connectors
Simply stated this means that a single fault should not result in an unacceptable risk. Please download Chrome or Firefox or 8036 our browser tips. This principle is embodied in the requirements of numerous medical device standards.
Life cycle A standard is reviewed every 5 years 00 Preliminary. Check out our FAQs. Take the smart route to manage medical device compliance.
However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. The faster, easier way to work with standards. Life cycle A standard is reviewed every 5 years 00 Preliminary. The intention is to provide accurate information; regardless; errors may exist in the supplied information. 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
Proof sent to secretariat or FDIS ballot initiated: This document does not specify requirements for the medical 803699 or accessories that use these small-bore connectors. 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 800369.
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.
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.
Final text received or FDIS registered for formal approval. 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 8036 connectors for applications are listed. 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.
ISO Small-bore Connectors in Healthcare Applications
Kso parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories. Connectors for limb cuff inflation applications – Part 6: Proof sent to secretariat or FDIS ballot initiated: To purchase a copy visit an Authorized Reseller.
This International Standard also specifies the healthcare fields in which these small-bore connectors are intended to be used. July Replaced By: These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient. Accept and continue Learn more about the cookies we use and how to change your settings.
BS EN ISO 80369-1:2010
You may be interested in: ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids oso gases in healthcare applications. ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.
Such requirements are given in particular International Standards for specific medical devices or accessories. Therefore it is not surprising that misconnections are made.
You may experience issues viewing this site in Internet Explorer 9, 10 or 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. Live Chat Powered by jivochat.
In a coronary care unit there are as many as jso Luer connectors on the medical devices used with a single patient.