BS EN ISO 9997:2020 pdf free.Dentistry – Cartridge syringes.
The cartridge shall be capable of being loaded either from the side or from the back (breech type). The cartridge syringe shall permit the appropriate size of local anaesthetic cartridge to be securely held and incapable of being dislodged during use.The cartridge end of the plunger rod shall contain either a permanently attached tip or a means of securing various plunger tips supplied by the manufacturer of the cartridge syringe. Test in accordance with 6.1. The plunger rod shall be capable of travelling freely and smoothly the whole length under the force of gravity in both vertical directions. Test in accordance with 6.6.1. The maximum sideways displacement of the plunger rod tip shall not exceed 1 mm in any direction from the central axis of the syringe. Test in accordance with 6.6.2.Aspirating syringes shall permit aspiration at any time during use. WARNING一Some aspirating syringes are intended for use only with cartridges fitted with specially designed plungers. These syringes may not aspirate when used with any other cartridges.When used with a cartridge in accordance with ISO 11499, the reagent shall have been aspirated into the cartridge and the harpoon or threaded portion of the plunger rod shall not have been disengaged.  Test in accordance with 6.4. Use a cartridge in accordance with ISO 11499. After testing, the reagent (see 6.4.1) shall have been aspirated into the cartridge. Test in accordance with 6.5.All components of the cartridge syringe shall (including those made of plastic) comply with the requirements of 5.3 and 5.4, and in addition, shall show no signs of corrosion after 100 reprocessing cycles when tested in accordance with 6.7. If the manufacturer states a maximum number of reprocessing cycles less than 100, this maximum number shall be used instead.Assemble the cartridge syringe, cartridge and needle of dimensions 0,4 mm x 35 mm. Fix the harpoon or threaded portion of the working end of the plunger rod to the plunger of the local anaesthetic cartridge in accordance with the instructions for use. Immerse the needle in the coloured liquid (see 6.4.1) and depress the plunger for 5 mm at a rate of 5 mm/s and then, at the same rate, withdraw the plunger until the reagent appears in the cartridge or for a maximum distance of 5 mm. Repeat the test three times with the same local anaesthetic cartridge.BS EN ISO 9997 pdf download.