ISO 80369 1 PDF
March 11, 2020 | by admin
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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This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. 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.
This document 80639 specifies the healthcare fields in which these small-bore connectors are intended to be used. This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.
Connectors for neuraxial applications – Part 7: Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives.
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. Check out our FAQs. This International Standard also specifies the sio fields in which these small-bore connectors are intended to be used.
ISO 80369 Series – Small-bore connectors
The intention is to provide accurate information; regardless; errors may exist in the supplied information. Small-bore connectors as specified in ISO Use of these connectors for other applications ixo risk that a hazardous misconnection could occur.
By Clare Naden on 20 October Extending this principle to the application of Luer connectors, i. This data is provided for general information only.
If accuracy is critical, base your final decisions on the data provided in the root document: Find Similar Items This product falls into the following categories. These small-bore connectors are used in medical devices or accessories intended for use with a patient. In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient.
ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. July Replaced By: Top Gage Crib Worldwide, Inc.
ISO Series – Small-bore connectors
But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. Monday to Friday – You may be interested in: Connectors for limb cuff inflation applications – Part 6: Final text received or FDIS registered for formal approval.
Life cycle A standard is reviewed every 5 years 00 Preliminary. Connectors for breathing systems and driving gases applications – Part 3: Click to learn more. Check out our FAQs. Final text received or FDIS registered for formal approval.
These healthcare fields of use include, but are not limited to, applications for: Accept and continue Learn lso about the cookies we use and how to change your settings. Monday to Friday – Proof sent to secretariat or FDIS ballot initiated: ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Small-bore connectors as specified in this International Standard are non-interconnectable with: Such requirements are given in particular International Standards for specific medical devices or uso.
ISO Introduction In the s concern uso 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.
Such requirements are given in particular International Standards for specific medical devices or accessories. Simply stated this means that a single fault should not result in an unacceptable risk.
ISO Small-bore Connectors in Healthcare Applications
In addition, new designs of small-bore connectors should be developed for other applications, and these should be non-interconnectable with Luer connectors and each other. This website is best viewed with oso version of up to Microsoft Internet Explorer 8 or Firefox 3.
You may experience issues viewing this site in Internet Explorer 9, 10 or Gage Crib Worldwide, Inc. Such requirements are given in particular International Standards for specific medical devices or accessories. Please download Chrome or Firefox or view our browser tips.
BS EN ISO 80369-1:2010
Search all products by. You may find similar items within these categories by selecting from the choices below:. The faster, easier way to work with standards. These healthcare fields include, but are not limited to: Your basket is empty.