Iso 594-2 Pdf
Basa Benejan
ISO 594-2 covers conical lock fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment. The standard covers rigid and semi rigid materials and details the test methods.
Scope: ISO 594-2 specifies requirements for conical lock fitting with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use such as transfusion equipment.
ISO 594-2 requirements pertain to fittings made of rigid and semi-rigid materials and include the testing methods and procedures. ISO 594-2 excludes provisions for more elastomeric or flexible materials. It is difficult to define with accuracy the characteristics of rigid and semi-rigid materials but plastics in general would be considered semi-rigid and metal and glass would be considered rigid.
(G) The maximum inside diameter of the external thread or the maximum outside diameter of the female lock fitting at base of lugs. The diameter should not be increased for a distance from the hub face of 5.5mm. For Figures 1, 2, 3a and 4 the dimension should be 6.73mm. For Figures 3b and 3c the dimension is 5.7.
(V) Maximum chord length at the edge of lug in a plane at right angles to axis of fitting only, to be measured on a chord of a circle, the diameter which is J min (7.0mm). The chord length is 3.5mm for Figures 1, 2, 3a and 4 and 5.0 for Figures 3b and 3c.
Qosina offers a variety of intravascular and hypodermic male and female connectors, stopcocks, hemostasis valves, and check valves that are compliant with the ISO 80369-7 standard. ISO 80369-7 components are in stock and available for immediate delivery. The ISO 80369-7 standard replaces ISO 594-1 and ISO 594-2, but it has been consolidated and technically revised. It is expected that all existing ISO 594 connectors will meet the requirements of ISO 80369-7 by 2021, and that when testing or validation occurs, it is made using the requirements of ISO 80369-7.
The Qosina full-line catalog contains OEM medical device component supplies and features full-scale photographs of thousands of stock components on a one-centimeter grid. Qosina offers low minimums and short lead times on intravascular and hypodermic components for single-use systems.
ISO 80369-7 connections following the intravenous (artery/veins) therapy (IV) design include systems with the purpose of infusion of liquid through intravascular or hypodermic applications. This series will replace the current ISO 594-1 and the ISO 594-2. No physical changes to the current luer specification are anticipated.
The Luer taper is a standardized system of small-scale fluid fittings for making leak-free connections between sections on medical and laboratory instruments, including hypodermic syringe tips, catheters and infusion devices. ISO 594-1 is the standard specification and test method for the design of such Luer taper fittings. The two varieties of Luer Taper connections are typically known as Luer-Lock and Luer-Slip. The Luer-Lock standard connection can be tested according to ISO 594-2.
ISO 594-1 provides test methods for testing the separation force of Luer fitting assemblies. For testing of separation force and unscrewing torque, take a look at ISO 594-2. Separation force is tested by applying a tensile axial force from a fatigue test machine. The testing standard asks for a tensile axial force to be applied progressively up to 25 N, at a rate of 10 N/s, and holding the force for at least 10 seconds.
For all tests in ISO 594-1 requiring an assembled Luer fitting, fittings are assembled using an axial torsion machine, applying a compressive force not greater than 27.5 N and a torque not greater than 0.1 Nm without exceeding 90 degrees rotation.
ISO 594-2 provides test methods for testing the separation force of Luer fitting assemblies and unscrewing torque of Luer fitting assemblies. For testing of separation force without unscrewing torque, take a look at ISO 594-1.
Separation force is tested by applying a tensile axial force progressively up to 35 N, at a rate of 10 N/s, and holding the force for at least 10 seconds. Unscrewing torque is tested by applying a 0.02 Nm counter-clockwise torque, maintaining this torque for at least 10 seconds. For all tests in ISO 594-2 requiring an assembled Luer fitting, fittings are assembled using an axial torsion machine, applying a compressive force not greater than 27.5 N and a torque not greater than 0.12 Nm.
ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors. Its publication in October 2016 capped a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee's desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.
Why the Change? Prior to ISO 80369, every small-bore connector was a Luer and, under ISO 594, there was a lot of design leeway on what those Luers looked like. ISO 80369 aims to reduce variation in order to prevent errors in connecting to the patients; errors that were sometimes fatal.
What Is the Difference Between ISO 594 and ISO 80369? Compliance to ISO 594 requires two things: gauging (for which failures could often be justified away) and meeting performance requirements. ISO 80369-7 requires three things: full compliance with materials, dimensional requirements, and performance requirements. All three are required in order to maintain the assumption of non-interconnectability.
Prior to the implementation of ISO 80369-7, the ubiquitous use of Luer connectors made it possible for two incompatible devices to be accidentally connected, which could lead to patient injury. The principal goal of ISO 80369 is to reduce the likelihood of these adverse events by introducing unique connector designs for different medical applications whose geometry makes it extremely difficult to make these harmful connections.
One consequence of using the geometry of the connectors to preclude misconnections is that the connectors now need to be measured to ensure that they meet the dimensions and tolerances of the prints in the standard. This differs dramatically from ISO 594, where as long as connector performance could be proven against a reference standard, the dimensions of the connector largely did not need to precisely match the standard. This is by far the most burdensome new requirement resulting from the standards change and many in industry are incredulous to learn that their thread design that has performed adequately must now be changed.
In addition to stricter dimensional requirements, there are also new restrictions on what materials may be used to construct Luer connectors. The elastic modulus of the materials must be greater than 700 MPa when tested in either tension or flexure per standard ASTM methods. Some polymers commonly used as Luer connectors do not meet this requirement, including many polyethylenes.
The separation of ISO 594-1 for slip Luers and 594-2 for locking Luers created a convenient distinction between their separate requirements, but also a lack of clarity about if and when both sets of tests needed to be performed. ISO 80369-7 contains both requirements within the same document but is still not explicit about when one should invoke the tests against both slip and lock reference connectors.
This is an important consideration when qualifying a female locking Luer, as both male slip and locking Luers can easily be connected. The simplest answer is that if a device with a female locking Luer is intended to connect with a specific device that has a male locking Luer, then the female locking Luer only needs to be tested against the male locking reference connector. If the device's use is not as specific, or if it's uncertain, then both sets of requirements are in play. Table 1 lists the test requirements for each possible configuration.
One of the critical elements of ISO 594 was a standardization of the torque and axial force used to assemble a test sample to a reference connector. ISO 80369-20, which is the standard that defines how to conduct the test methods, narrows the range of acceptable torque and axial force, utilizes the same assembly values for every test, and clarifies the assembly procedure for products with floating or rotatable collars. Table 2 outlines the assembly parameters of ISO 594 and 80369. In addition to changes in the assembly parameters, many of the tests have changed substantially as well; titles and test parameters have been modified, new tests have been added, and the ease of assembly test was eliminated because of its subjectivity. Table 3 compares and contrasts some of the most significant changes to each test.
Annex J in ISO 80369-20 contains specific instructions and guidance on how each test can be modified in order to obtain data of a variable (numerical) type, which may help to reduce the sample size needed in order to achieve the desired confidence intervals. For some tests, e.g. sub-atmospheric pressure air leakage, the change is trivial, only requiring one or two additional calculation steps.
For others, like the positive pressure falling drop liquid leakage test, the apparatus used to perform the variable test method requires additional levels of control beyond what is needed to perform the attribute test method. The determination of whether or not to utilize the variable methods is typically made on a case-by-case basis and takes into account the potential extra test method validation work, fixturing, and increased cost for tests that require more time and complex equipment to perform.
ISO 80369-1 states that small-bore connectors of each application category shall be non-interconnectable with any of the small-bore connectors of every other application category, unless otherwise indicated in ISO 80369-1 or within the ISO 80369 series. Based on this, manufacturers will need to demonstrate that the small-bore connector under test exhibits non-interconnectable characteristics when evaluated against connectors of other application category, in addition to ensuring that they safely and securely connect with their mating half.
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