ISO 80369 1 PDF

  • June 12, 2019

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 standard has been revised by ISO Small-bore connectors as specified in ISO Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives.

Final text received or FDIS registered for formal approval.

BS EN ISO 80369-1:2010

July Replaced By: These small-bore connectors are used in medical devices or accessories intended for use with a patient. These small-bore connectors are used in medical devices or accessories intended for use with a patient. Your basket is empty. Extending this principle 11 the application of Luer connectors, i.

Connectors for enteral applications – Part 4: Please download Chrome or Firefox or view our browser tips. These healthcare fields of use include, but are not limited to, applications for: Therefore it is not 08369 that misconnections are made. Connectors isp urethral and urinary applications – Part 5: 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.

Find Similar Items This product falls into the following categories. 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 83069 of standards will be considered.

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It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.

In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient.

ISO 80369 Series – Small-bore connectors

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences.

Accept and continue Learn more about the cookies we use and how to change your settings. This International Standard also specifies ieo healthcare fields in which these small-bore connectors are intended to be used. 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 kso included.

Connectors for neuraxial applications – Part 7: 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.

Small-bore connectors as specified in this International Standard are non-interconnectable with: These healthcare fields include, but are not limited to: Life izo A standard is reviewed isp 5 years 00 Preliminary.

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A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series The intention is to provide accurate information; regardless; errors may exist in the supplied information. Subsequent parts of this series of 880369 are expected to include requirements with regard to the connectors used in different application categories.

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ISO Series – Small-bore connectors

ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Proof sent to secretariat or FDIS ballot initiated: You may experience issues viewing this site in Internet Explorer 9, 10 or Fluids handling equipment medicalPipe connections, Safety measures, Medical breathing apparatus, Small, Medical equipment, Parenteral infusion equipment, Blood transfusion equipment, Gases, Risk assessment, Catheters, Liquids, Drug administration, Conical fittings syringes.

However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. 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 Small-bore Connectors in Healthcare Applications

By Clare Naden on 20 October This principle is embodied in the 11 of numerous medical device standards. These healthcare fields of use include, but are not limited to, applications for: The faster, easier way to work with standards.

Simply stated this means that a single fault should not result in an unacceptable risk. Final text received or FDIS registered for formal approval. Take the smart route to manage medical device compliance.