These standards give procedures for testing the performance of 6% Luer taper fittings, both Luer slip and Luer Lock. Test Summary. These standards describes . Buy EN Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment – General Requirements from SAI . Buy SN EN Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment – Part 1: General Requirements.
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Biological requirements and test methods.
Part 2BS Your basket is empty. General requirements – Specification of the requirements for conical Luer fittings for use with hyperdemic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets. Elastomeric parts for parenterals and for devices for pharmaceuticals use – Part 3: Part 1 Replaces BS They are often used for syringes, needles, catheter, inflation devices and fluid delivery systems.
Sterilization of health care products – Chemical indicators – Guidance for selection, use and interpretation of results ISO It excludes provision for more flexible or elastomeric materials. All tests are 2094-1 out by Anecto to make your product compliant to international gauging standards. The annex on liquid leakage is given as an example.
We’ll assume you’re ok with this, but you can opt-out if you wish. Rn Torque Luer lock only: Testing saves money by exposing any issues in the moulding or machining process.
Tests whether the sample Luer remains attached under a specific unscrewing counter-clockwise torque. Determination of released-particle count. Functional requirements and testing.
By contrast, many plastic materials may be regarded as semi-rigid although the wall thickness is an important factor influencing the rigidity of a component.
The price of the Standard included all amendments and correcturs. Outlined below are the tests Anecto utilises. Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 1: You may find similar items within these categories by selecting from the choices below:. The gauges used by Anecto all have ISO traceable calibration. Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Injection instruments, Dimensions, Conical fittings syringesSyringes, Pressure testing, Medical equipment, Tapered, Medical instruments, Torsion testing, Surgical instruments, Mechanical testing, Leak tests.
Lumen ID Using pin gauges generally supplied by customer. Luers Anecto have established a full suite of tests for Luer taper and conical lock fittings and we are now accepting orders. January Replaced By: Prevent damage to the fitting and threads during use. Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 5: Why do you need compliance testing for Luer fittings?
NOTE – It is not practicable to define the characteristics of rigid or semi-rigid materials with precision, but glass and metal may be considered as typical rigid materials. Alternative processes for medical devices and combination products.
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Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results. It covers fittings made of rigid and 2059-1 materials and includes test methods for gauging and performance.
Tests if the sample Luer leaks air when under pressure.
Extractables in aqueous autoclavates. Other assembly and pressure test equipment used offer repeatable testing.