BS EN ISO 7864 pdf free download

BS EN ISO 7864 pdf free download. Sterile hypodermic needles for single use — Requirements and test methods (ISO 7864:2016).
4 Requirements 4.1 General Testing finished products shall be conducted on sterilized products. 4.2 Statistics and reproducibility of test methods Any suitable test system can be used when the required accuracy (calibration) and precision [Gauge repeatability and reproducibility (R&R)] can be obtained. 4.3 Cleanliness When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under 2,5× magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter. 4.4 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid. 4.5 Limits for extractable metals When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract prepared in accordance with Annex A shall, when corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0,1 mg/l. 4.10.3 Freedom from defects When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the outer surface of the tubing shall be smooth and free from defects. 4.10.4 Lubricant If the hypodermic needle tube is lubricated, the lubricant shall not be visible, under normal or corrected vision, as droplets of fluid on the outer or inner surfaces of the needle tube. An acceptable lubricant, applied undiluted, is polydimethylsiloxane complying with a national or the European pharmacopoeia. The quantity of lubricant used should not exceed 0,25 mg/cm 2 of the lubricated surface area of the needle tube. 4.11 Needle point When examined under 2,5× magnification the needle point shall appear sharp and free from feather edges, burrs and hooks. NOTE The needle point usually has a bevel with a primary bevel angle of 11° ± 2° (as illustrated in Figure 3), but a “short” bevel with other angle, e.g. 17° ± 2°, can be provided. The designation of needle point dimensions and the nomenclature used to describe the dimensions and features is shown for information in Figure 3. The needle points shown are of configurations commonly manufactured: other configurations may be equally satisfactory. It may not be necessary to use all the dimensions when describing the point configuration. The needle point should be designed so as to minimize coring and fragmentation when penetrating vial closures. This International Standard does not specify requirements or test methods for these properties, but an example of a test method for determining the production of fragments from rubber closures is given in Annex B. Penetration testing can provide an indication of the needle point sharpness and lubrication. An example of a test method for determining the needle penetration performance is given in Annex D.BS EN ISO 7864 pdf download.