ISO 7864-16:2016 pdf free
ISO 7864-16:2016 pdf free.Sterile hypodermic needles for single use一Requirements and test methods
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.
Each hypodermic needle shall be sealed in a unit package. The material and design of this packaging shall be such as to ensure that the colour coding of the contents is visible.
The materials of the packaging shall not have detrimental effects on the contents. The materials and design of this container shall be such as to ensure:
a) the maintenance of sterility of the contents under dry, clean and adequately ventilated storage conditions;
b) the minimum risk of contamination of the contents during removal from the container;
c) adequate protection of the contents during normal handling, transit and storage;
d) that once opened, the container cannot be easily resealed, and it shall be obvious that the container has been opened.
As appropriate, depending on the needle size and geometry of the needle, patency of the lumen shall be determined by either:
a) a stainless steel stylet of the appropriate diameter selected from the diameters given in Table 3 shall pass through the needle;
b) the flow rate of water through the needle shall not be less than 80 % of an unprocessed needle tube of equivalent outer diameter and length having a minimum inner diameter in accordance with ISO 9626 when tested under the same pressure.ISO 7864-16 pdf download.
