ISO 9997:1999 download free.Dental cartridge syringes.
ISO 9997 specifies requirements and test methods lot dental cariridge syrInges which are reusable dental syringes of the aspirating, non.asoraung and sefl aspirating types using cartridges with dental local anaeslhetlcs.
ISO 9997 is not pIlcabie to cartridge syringes having a mechanlcal•arivantage action for ueatlng high pressure.
2 NormatIve references
The following normative docLsnents contain provisions which, through reference in this text. constitute provisions of ISO 9997. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on ISO 9997 are encouraged to investigate the possibility of appiyrng the most recent editions of the nomlattve documents Indicated below. For undated references. the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently vakd International Standards.
Iso 261. ISO general pwpose metric screw If weads — General pAan
ISO 965.1 ISO general purpose metilc screw threads — Tolerances — Part 1: PhocicJes arid bas.c data.
ISO 1942-3, Denial oca&da,y — Pail 3: Dental instruments.
ISO 11499, Dental cartridges for local anaesthetics,
ISO 13402:1995, SUrgiCal and dental hand instruments — Determination of resistance against aulociaving.
con’osion and thermal exposure,
3 Terms and definitions
For the purposes of ISO 9997, the terms and definitions given In ISO 1942•3. iSO 11499 and the following apply.
process by which blood or body fluid Is drawn Into an anaesthetic cartridge
pad containing a denial cartridge syringe
container for local anaesthelics
For the purposes of ISO 9997. dental cartridge syringes are classified Into the following types:
— Type 1: non -aspirating
— Type 2: aspIrating
— Type 2a: aspwallon by force produced by drawing the plunger away from the needle
— Type 2b. aspiration by lorce produced by the dellectlon o4 a diaphragm in the cartridge.
General requirements for dental cartridges for local anaesthelics as specilied in ISO 11499 shall be met.
5.1.1 Loading and cartridge size
The cartridge shall be capable of being loaded either from the side or from the back (breech typet. The syringe shall permit the appropriate size of local anaesthetic cartridge to be securely held and incapable of being dllslodged dunng use.
Testing shall be carried out in accordance with 6.1.
5.1.2 VIewing of contents
The syringe shall allow the solution for injection to be observed, including the result of aspiration.
Testing shall be carried out In accordance with 22.214.171.124 and 8.3.
5.1.3 Plunger rod
The plunger rod shall satisty test 6,4 before and alter the tests In 126.96.36.199 and 6.7.
The cartridge end cil the plunger rod shall contain either a permanently attached tip or a means 01 securing various plunger tips supplied by the manufacturer of the cartridge syringe.
Testing shall be carried out in accordance with 6,1.
5.1.4 AspIrating syringes
Aspwaling syringes shall permit aspiration aty lime during use.
NOTE Some aspirating syringes are tiIend lot use only with cartridges litted with speay designed ruer pI,mgers.
These syringes may net aspirate when ueed with any other ca,lridges.
188.8.131.52 SyrInges In which aspiration is achIeved by movIng the cartridge plunger away from the needle
Testing shall be carried out using a cartridge complying with ISO 11499. Altec testing, the reagent (6.2.1) shall have been aspirated into the cartridge and the harpoon or threaded portion of the plunger rod shall not have disengaged. Testing shall be carried out In accordance with 6.2.2
184.108.40.206 Syringes In which aspiration Is achieved by deflection of a diaphragm wtthln 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 carned out in accordance wIth 6.3.2.
5.2.1 Metal syringes
The parts shall be capable of withstandln9 repeated slerilizabon without Impairing the function of the syringe and without showing signs of corrosion such as blemishes, pitlings or discolouration.
Testing shalt be carried out in accordance with 6.1 and 6.5 and si.it,sequeatty 6,6 and 6.7.
5.2.2 Plastics syrInges, Including metal syringes with plastic parts
The material shall be capable of withstanding repealed stenhizatlon wrihout impairing the function 01 the syringe and without showing deterioration of the malerial of construction
Testing shall be carried out In accordance with 61.6.5 and subsequently 6.8.
Any metal part shall comply with the requirements of 5.2.1.
The dimensions shea be as specified in Figure 1 and the metricthreaded needle-mounting hub shall meet the
requirements far screw threads in accordance with ISO 261 and ISO 965-1.
6 Test methods
6.1 VIsual Inspection
Visual inspection shall be conducted at normal visual acuity without magnhlicabon.
6.2 Aspirating test for syringes of Type 2a
A coloured liquId, for example an aqueous solution of methyiene blue, With a viscosity of 4 m Pa’s (0.04 poIse) at
Assemble the syringe, cartridge and needle of dimensions 0,4 mm x 35 mm. Fix the harpoon or threaded portion ol the working end of the plunger rod to the plunger of the local anaesthetic cailndge in accordance with the manufacturer’s instructions. Immerse the needle in the coloured liquid (62.1) and depress the plunger for 5mm 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 5mm. Repeat the test three times with the earns local anaesthetic cartridge.
Observe whether the requirement of 5.1.42 Is fulfilled after each withdrawal of the plunger.
6.3 AspIrating test for syringes of Type 2b
A coloured bquid, for example see 62.1.
Assemble the syringe. cartndge and neerie of dImensions 0.4mm x 35mm, Depress the plunger 5 mm dering Is. Release the pressure and then immediately again depress the plunger a further 5 mm tar 1 s. Immediately after this second depression, immerse the necle en the coloured Iued (6,31) and depress the plunger at a rate at 5 mnVs for 5 mm and release the pressure.
Observe wheiher the requirement of 220.127.116.11 is fulfilled.
6.4 Plunger rod tests
6.4.1 Plunger rod movement
When the plunger rod is pulled fuffy out of an empty syringe held verticalfy, it shall be capable of travelling freely and
smoothly the whole length under the farce of gravity in both vertical directions by inverting the syringe.
6.4.2 Plunger rod displacement
With the plunger in the fully torward position in the syringe (without a cartridge) the maximum sideways displacement measured at the Iront end of the plunger rod tip shall not exceed 2 mm in any direction from the central axis of the syringe.
ISO 9997:1999 download free.Dental cartridge syringes.