BS EN ISO 9997:2020 pdf download.Dentistry – Cartridge syringes.
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 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.
6.7 Resistance to reprocessing Carry out 100 reprocessing cycles with the cartridge syringe, in accordance with the manufacturer’s instructions for use, in accordance with ISO 17664. The reprocessing cycle shall include the manufacturer’s recommended methods of cleaning, disinfection and sterilization. If the manufacturer states a maximum number of cycles less than 100, use this number of cycles for the test. Inspect the syringe for any signs of corrosion, pitting, distortion or other surface damage. Repeat the testing for 5.3 and 5.4.BS EN ISO 9997 pdf download.