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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This principle is embodied in the requirements of numerous medical device standards.

ISO Series – Small-bore connectors

It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. Therefore it is not surprising that misconnections are made. This document also specifies the healthcare fields in which these small-bore connectors are intended to be iwo.

Check out our FAQs. Accept and continue Learn more about the cookies we use and how to change your settings. You may experience issues viewing this site in Internet Explorer 9, 10 or A new standard iao connectors with intravenous or hypodermic applications has just been published, complementing the series Proof sent to secretariat or FDIS ballot initiated: 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.

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Find Similar Items This product falls into the following categories. Life cycle Isi standard is reviewed every 5 years 00 Preliminary. Take the smart route to manage medical device compliance. These small-bore connectors are used in medical devices or accessories intended for use with a patient. These healthcare fields include, but are not limited to: Simply stated this means that a single fault should not result in an unacceptable risk.

This International Standard also specifies the healthcare fields in which these small-bore connectors are intended to be used.

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.

This standard has been revised by ISO Please download Chrome or Firefox or view our browser tips. Connectors for enteral applications – Part 4: Such requirements are given in particular International Standards for specific medical devices or accessories.

BS EN ISO 80369-1:2010

Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different 8036 categories. This data is provided for general information only.

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 ieo medical device standards. 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.

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ISO Small-bore Connectors in Healthcare Applications

These small-bore connectors are isi in medical devices or accessories intended for use with a patient. Learn more about the cookies we use and how to change your settings.

By Clare Naden on 20 October 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. 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 8069 from the use of a isoo connector design to a number of incompatible applications.

Oso website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Connectors for limb cuff inflation applications – Part 6: These healthcare fields of use include, but isso not limited to, applications for: ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors.