ISO 9997:1999 pdf download – Dental cartridge syringes
ISO 9997:1999 pdf download – Dental cartridge syringes.
18.104.22.168 Syringes in which aspiration is achieved by deflection of a diaphragm within the cartridge (Type 2b)
Use cartridges complying with Iso 11499. After testing, the reagent (6.2.1) shall have been aspirated into the cartridge.
Testing shall be carried out in accordance with 6.3.2.
5.2.1 Metal syringes
The parts shaJl be capable of withstanding repeated sterilization without impairing the function of the syringe and without showing signs of corrosion such as blemishes, pitlings or discolouration.
Testing shall be carried out in accordance with 6,1 and 6.5 and subsequently 6.6 and 6.7.
5.2.2 Plastics syringes, including metal syringes with plastic parts
The maleriai shall be capable of withstanding repeated sterilization without impairing the function of the syringe and without showing deterioration of the material of construction.
Testing shall be carried out in accordance with 6.1. 6.5 and subsequently 6.6.
Any metal pan shall comply with the requirements of 52.1.
The dimensions shall be as specified in Figure 1 and the metric-threaded needle-mounting hub shall meet the
requirements br screw threads in accordance with ISO 261 and ISO 965-1.
6 Test methods
6.1 Visual Inspection
Visual inspection shal be conducted at normal visual acuity without magnitication.
6.2 Aspirating test for syringes of Type 2a
A coloured liquid, for example an aqueous solution 01 methylene blue, with a viscosity of 4 mPas (0,04 poise) at (23±2)°C.
Assemble the syringe, cartridge and needle ol dImensions 0,4 mm x 35 mm. Fix the harpoon or threaded portion of the working end of the plunger rod to the pk,nger of the local anaesthetic cartridge in accordance with the manufacturer’s instructions. Immerse the needle in the coloured bquid (6.2.1) and depress the plunger for 5 mm at a rate ot 5 mm/s arid 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.
6.5 Boiling water test for corrosion
Test tile dental cartridge syringe In accordance with ISO 13402:1995. clause 4.
Perform the cycle live times,
Visually inspect (see 6.1) for compliance with the requirements of 5.2.1 or 5.2.2 as appropriate.
6.6 Autoclave test for corroston
Test the dental cartridge syringe in accordance with ISO 13402:1995, clause 3.
Perform me cycle five limes.
Visually inspect (see 6.1) for compliance with the requirement of 5.21 or 5.2.2 as appropriate.
6.7 Thermal test (metal syringes only)
Test the dental cartridge syringe in accordance with ISO 13402:1995, clause 6.
Perform me cycle frye limes,
Visually inspect (see 6.1) for compliance with the requirement 01 5.2.1.
7 Information supplied by the manufacturer
Each dental cartridge syringe shall be accompanied by at least the following information:
a) recommended methods to’ cleaning and sterilization;
b) method of inserting the cartridge and attaching the needle:
C) method of assembly. if appropriate;
d) technique to be used for aspiration, it applicable.
8.1 Marking of unit pack
Each unit pacl see 3.2) shall be marked with the following Information:
a) name or registered trademark Of the manufacturer;
b) words dental cartridge syringe;
C) type aspirating or non-aspiating. as appropriate:
d) it aspirating, type of aspiration;
e) details of the neecSe-mounuing thread:
f) size(s) and type of cartridge(s) to use with the syringe;
g) lot number.
8.2 MarkIng of syringe
Each syringe shall be indelibly marked with the name or registered trademark of the manufacturer.