BS EN ISO 9997:2020 pdf – Dentistry – Cartridge syringes.
5.4.2 Viewing of contents The cartridge syringe shall allow the solution for injection to be observed, including the result of aspiration. Test in accordance with 6.1, 6.2, 6.3 and 6.4. 5.4.3 Plunger rod 220.127.116.11 Plunger rod design 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. 18.104.22.168 Plunger rod movement 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. 22.214.171.124 Plunger rod displacement 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. 5.4.4 Aspirating syringes 126.96.36.199 General Aspirating syringes shall permit aspiration at any time during use. WARNING? —? 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. 188.8.131.52 Type 2 syringes 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. 184.108.40.206 Type 3 syringes 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.
5.5 Resistance to reprocessing 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. 6 Measurement and test methods 6.1 Visual inspection Carry out visual inspection with normal visual acuity and without magnification. 6.2 Dimensions Measure the dimensions using a measuring device that is accurate to 1/10 of the tolerance to be measured. 6.3 Secure loading Place an appropriate size of local anaesthetic cartridge in a cartridge syringe. Move the syringe forward/backward and sideways and assess if the cartridge is securely placed. 6.4 Aspirating test for cartridge syringes of Type 2 6.4.1 Reagent A coloured liquid, for example an aqueous solution of methylene blue, with a viscosity of 4 mPa.s (0,04 poise) at (23 ± 2) °C. 6.4.2 Procedure Assemble the cartridge syringe, cartridge and needle of dimensions 0,4 mm × 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. 6.4.3 Observation Observe whether the requirement of 220.127.116.11 is fulfilled after each withdrawal of the plunger. 6.5 Aspirating test for cartridge syringes of Type 3 6.5.1 Reagent A coloured liquid, as described in 6.4.1.
6.5.3 Observation Observe whether the requirement of 18.104.22.168 is fulfilled. 6.6 Plunger rod 6.6.1 Plunger rod movement Hold the empty cartridge syringe vertically. Move the plunger rod fully out of the syringe, and release. Invert the syringe and repeat the test. Check if the plunger rod is capable of travelling freely and smoothly, the whole length under the force of gravity in both vertical directions. If it is capable of travelling freely and smoothly, the whole length, this test is passed. 6.6.2 Plunger rod displacement Hold the cartridge syringe (without a cartridge) vertically. Move the plunger rod in the fully forward position. Measure any movement at the front end of the plunger rod tip in all directions from the central axis. If the maximum sideways displacement of the plunger rod tip does not exceed 1 mm, this test is passed.