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    Home > Active Ingredient News > Drugs Articles > GB/T 18457-2015 Steely test method for the manufacture of stainless steel needle tubes for medical devices

    GB/T 18457-2015 Steely test method for the manufacture of stainless steel needle tubes for medical devices

    • Last Update: 2022-10-14
    • Source: Internet
    • Author: User
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    This standard specifies the size, surface and mechanical characteristics
    of the normal wall, thin wall and ultra-thin wall pipe of 0.
    6 mm ~ 2.
    1 mm of the metric specification 0.
    2 mm ~ 3.
    4 mm.
    This standard applies to needlecules for injection needles in the skin, subcutaneously, muscularly and intravenously of the human body and other medical devices (hereinafter referred to as needles).

    This standard does not apply to easy-bending stainless steel needles, because its mechanical properties are different from the hard straight stainless steel needles specified in this standard, but encourage manufacturers and buyers of easy-bending needles to choose the size
    specified in this standard.
    Needle tube rigidity test method: a prescribed force, applied to the center of the prescribed span of the needle tube supported at both ends, to measure the deflection value
    of the needle tube.
    Test Instrument: PMT-50N needle tube steel toughness tester testing requirements: 1.
    Rigidity test instrument can be through the force of the push rod to the maximum force of 60 N (precision of 0.
    01 N), downward vertical action on the needle tube force push rod The lower end of the force pusher is composed of a wedge and a cylindrical surface with a radius of curvature of l mm at a 60° angle to each other, and the width of the push rod is at least 5 mm
    .
    2.
    The instrument can measure the displacement
    of the needle tube with a reading accuracy of 0.
    01 mm.
    Test steps: 1.
    The needle tube is located on the rigid test instrument, 2.
    the value corresponding to the specification of the needle tube is measured in the span; 3.
    Make the end surface of the force pusher located in the center of the span; 4.
    Keep the needle tube perpendicular to the two needle holder posts and the force pusher, and at the same time make the needle tube centerline coincide
    with the needle rack centerline.
    5.
    According to the force corresponding to the nominal specifications of the needle tube in Table 2, the downward bending force is applied to the needle tube at a rate of 1 mm/min through the drag force
    pusher.
    6.
    Measure and record the deflection of the needle at the force point, accurate to 0.
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