ISO 9997-2020 pdf download.Dentistry一Cartridge syringes.
6.5.3 Observation
Observe whether the requirement of 5.4.4.3 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.
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.
7 Instructions for use
Each cartridge syringe shall be accompanied by at least the following information:
a) the indications for use;
b) the method of inserting the cartridge and attaching the needle;
c) the method of assembly, if appropriate;
d) the technique to be used for aspiration, if applicable;
e) the classification into type non.aspirating”, “aspirating or self.aspirating, as appropriate;
f) if aspirating, the type of aspiration;
g) the details of the needle-mounting thread;
h) the size (s) of cartridge(s) to use with the syringe;
i) the recommended methods of reprocessing for re-use;ISO 9997 pdf download.