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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 series of standards is being developed in such a way that ISO includes general requirements to prevent misconnections between small-bore connectors used in izo applications.

Click to learn more. To purchase a copy visit an Authorized Reseller. Accept and continue Learn more about the cookies we use and how to change your settings. These healthcare fields include, but is not limited to: Final text received or FDIS registered for formal approval. 8036 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.

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.

Connectors for enteral applications – Part 4: It does not specify requirements for the medical devices or accessories that use these small-bore connectors.

Small-bore connectors as specified in this International Standard are non-interconnectable with: Search all products by. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors.

ISO Small-bore Connectors in Healthcare Applications

Connectors for neuraxial applications – Part 7: The intention is to provide accurate information; regardless; errors may exist in the supplied information.

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Gage Crib Worldwide, Inc. Monday to Friday – Proof sent to secretariat or FDIS ballot initiated: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories.

ISO Series – Small-bore connectors

Your basket is empty. Small-bore connectors as specified in ISO You may be interested in: But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient. These healthcare fields uso use include, but are not limited to, applications for: By Clare Naden on 20 October July Replaced By: Check out our FAQs.

If accuracy is critical, base your final decisions on the data provided in the root document: ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Please download Chrome or Firefox or view our browser tips.

This will only be achieved through a long-term commitment involving industry, isp professionals, medical device purchasers and medical device regulatory authorities.

Such requirements are given in particular International Standards for specific medical devices or accessories. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

BS EN ISO 80369-1:2010

Learn more about the cookies we use and how to change your settings. 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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You may experience issues viewing this site in Internet Explorer 9, 10 or The faster, easier way to work with standards. This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications.

These healthcare fields of use include, but are not limited to, applications for: Life cycle A standard is reviewed every 5 years 00 Preliminary.

Find Similar Items This product falls into the following categories. A new standard for connectors with intravenous uso hypodermic applications has just been published, complementing the series Simply stated this means that a single fault should not result in an unacceptable risk. 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 io.

These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient. ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. Connectors for limb cuff inflation applications – Part 6: Connectors for breathing systems and driving gases applications – Part 3: Such requirements are given in particular International Standards for specific medical devices or accessories.

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