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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It does not specify requirements for the medical devices or accessories that use these small-bore connectors.
Please download Chrome iiso Firefox or view our browser tips. Proof sent to secretariat or FDIS ballot initiated: Iiso document specifies general requirements for small-bore connectors, which convey liquids or gases 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.
Click to learn more. Life cycle A standard is reviewed every 5 years 00 Preliminary.
ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: Find Kso Items This product falls into the following categories. A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series Connectors for breathing systems and driving gases applications 803369 Part 3: Concerns regarding 8369 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.
Connectors for enteral applications – Part 4: 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.
ISO 80369 Series – Small-bore connectors
This data is provided for general information only. Simply stated this means that a single fault should not result in an unacceptable risk.
This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. To purchase a copy visit an Authorized Reseller. ISO Scope Notes – NOTE 1 It is intended that new designs of small-bore connectors will be included in this series of standards after they have been assessed according to the procedure given in Clause 6.
ISO Series – Small-bore connectors
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. Live Chat Powered by jivochat.
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Search all products by. Top Gage Crib Worldwide, Inc. ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications.
You may be interested in: Such requirements are given in particular International Standards for specific medical devices or accessories. Proof sent to secretariat or FDIS ballot initiated: Gage Crib Worldwide, Inc. Such requirements are given in particular Iiso Standards for specific medical devices or accessories.
The intention is to provide accurate information; regardless; errors may exist in the supplied information. 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.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. Connectors for limb cuff inflation applications – Part 6: It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Monday to Friday – 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.
You may find similar items within these categories by selecting from the choices below:. July Replaced By: 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. 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.
These healthcare fields of use include, but are not limited to, applications for: This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. 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.
But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. These healthcare fields include, but are not limited to: Check out our FAQs.
These small-bore connectors are used in medical devices or accessories intended for use with a patient.
BS EN ISO 80369-1:2010
It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate 803369. 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. Fluids handling equipment medicalPipe connections, Safety measures, Medical breathing apparatus, Small, Medical 8069, Parenteral infusion equipment, Blood transfusion equipment, Gases, Risk assessment, Catheters, Liquids, Drug administration, Conical fittings syringes. Final text received or FDIS registered for formal approval.