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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ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: 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.
Subsequent parts of this 8039 of standards are expected to include requirements with regard to the connectors used in different application categories. ISO consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications: Connectors for breathing systems and driving gases applications – Part 3: Connectors for enteral applications – Part 4: Connectors for urethral and urinary applications – Part 5: Connectors for limb cuff inflation applications – Part 6: Connectors for neuraxial applications – Part 7: 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 803699 the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.
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 arising from the use of a single connector design to a number of incompatible applications. In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient.
Therefore it is not surprising that misconnections are made. Simply stated this means that a single fault should not result in an unacceptable risk. This principle is embodied in the requirements of numerous medical device standards.
ISO 80369 Series – Small-bore connectors
Extending this principle to the application of Luer connectors, i. 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. It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.
However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.
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.
ISO Small-bore Connectors in Healthcare Applications
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. ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.
This International Standard also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications 800369 Small-bore connectors as specified in this International Standard are non-interconnectable with: It does not specify requirements for the medical devices or accessories that use these small-bore connectors.
Such requirements are given in particular International Standards for specific medical devices or accessories.
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 8039 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.
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