BS EN ISO 7864 pdf free download

BS EN ISO 7864-2016 pdf free download.Sterile hypodermic needles for single use — Requirements and test methods (ISO 7864:2016).
4.7 Colour coding
The designated metric size of hypodermic tubular needles or the first full diameter from the tip of a tapered needle shall be identified by colour coding in accordance with ISO 6009 applied to the unit packaging and/or part of the needle assembly such as the needle hub or the needle cap.
4.8 Needle hub
4.8.1? Conical? fitting
The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-1, ISO 594-1 and ISO 594-2.
NOTE Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2.
4.8.2 Colour of hub
The hub shall be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in accordance with ISO 6009.
4.9 Needle cap
If a separate needle cap is provided, it shall be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in accordance with ISO 6009.
NOTE Figure 2 represents a typical configuration of a hypodermic needle. Specific designs can vary based on the packaging design of the manufacturer.
4.10 Needle tube
4.10.1 General
Needles according to the tubular needle designation shall be in accordance with ISO 9626. For tapered needles, manufacturers shall define how to apply the functional tests specifically stiffness and
resistance to breakage on the basis of a specific risk assessment carried out according to ISO 14971.
4.10.2 Tolerances on length
The actual length of the needle tube (see dimension L in Figure 2) shall equal the nominal length within the tolerances given in Table 1.
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.