ISO 20126:2012 download.Dentistry – Manual toothbrushes General requirements and test methods.
ISO 20126 specifies requirements and test methods for the physical properties of manual toothbrushes order to promote the safety of these prockicis for their Intended use.
ISO 20126 does not apply to manual interdental brushes and powered oral hygiene deviCes. as these instruments ere covered by separate International Standards
2 Normative references
The following referenced documents are indispensable for the application of th document For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (induding any amendments) applies.
ISO 1942, Dentzstry— Vocabulary
ISO 3696. Water tar anatytic& ?aboratoiy use— Specification and test methods
ISO 22254. Dentistry— Manual toothbrushes — Resilstance of tufted portion to dflection
3 Terms and definitions
For the purposes of ISO 20126, the terms and definitions given in ISO 1942 and ISO 22254 and the following apply.
manual toothbrush
hand-powered device, the working end of wt’Udi carries filaments pririardy for deanreg sta’faces within the oral cavity
NOTE Adapted from ISO 222542003. definition 3.1. brush head
working end of a manual toothbrush to which the filaments are attached NOTE Adapted from ISO 22254 2003. dellnthon 3.2.
3.3
filament
single strand within the brush head
P50 222542005, definition 3.3j
3.4
tuft
group of filaments gathered together and attached to the brush head
[1S0222542005, definitIon 341
3.5
tuft.removal force
force required to remove one tuft from the brush head
3.10
impact length
distance between the axis of rotation of the pendulum anti the pendulum stnking edge
NOTE Adapted from ISO 1302.1999. definition 3.8.
4 Requirements
4.1 Pass-fall criteria
Test eight samples of each type. If none of the eight samples of each type fad, the sample set passes. If one sample does not meet the mirwrium requirement, test another eight samples. If no more samples fad, the Ioothbrush passes. If two or more samples out o the sixteen fail, the toothbrush fads.
4.2 PhysIcal Inspection
The toothbrush shad be intact, and free of visible contamination and sharp or rough surfaces when examined according to 5.3.
4.3 Tuft retention
The tuft-removal farce shall be not less than 15 N when tested accordmg to 5.4.
4.4 Fatigue resistance
The toothbrush shall compete 75000 cycles without breaking when tested according to 5.5.
NOTE A cycie is one application cit force followed by removal of the force.
4.5 Chemical challenge
The toothbrush shall comply with 4.4 after being subjected to a chemical challenge according to 5,6.
4.6 Handle impact strength
When tested In accordance with 5.7, the handle should not fracture If the handle does fracture, however, the nwnimum absorbed energy at fracture shall be 0,8 J.
5 Test method
5.1 Sampling
Obtain the toothbrushes for testing as manufactured and not modified In any way, except as specified In ISO 20126.
5.2 General test conditions
Conduct the tests using dry toothbrushes at a temperature of (23 i 5) °C and a relative humidity of (50 ± 10) %.
5.3 Physical inspection
Inspect the toothbrush and related accessories using normal acuity without magnification. Use tactile mspection to detect sharp or rough surfaces.
5.4 Tuft.ietention test
5.4.1 Apparatus
5.4.1.1 GrippIng unit to secure Uie brush head. having a structure such that comprewve force Is not duced on the fulls. See Figure 2.
5.4.1.2 Clamp, for securely holdIng .0 the filaments In one tuft, e.g. a tuft-Ipplng damp or a Collet chuck used to grip a tuft, and consisting of an outer shell that slips over the filaments and a probe W$IICh screws Into the shell, pinching the fdaments between It and the shell.
5.4.1.3 Apparatus for applying, measuring and Indicating the removal force, e.g. digital force gauge or universal testing machine (force range: 5 N to 50 N, accuracy 0.1 N. range of pulling speed: 20 mm/mi., to 100 mm/mln)
5.4.2 Procedure
Place the toothbrush In the gnpplng unit (5.4,11) and lock it mb place so that the clamp (54.1,2) pulls the tuft along the long woe of the tuft, without any twisiwig, Do not compress the tufts during or after placement.
Place the clamp on the filament tuft, ensuring that all the filaments from one tuft only are clamped; do not rclude filaments from the surrounding tufts. Secure the filaments from the tuft at approximatelyth. mid-point of the tuft length. Record the force required to pull out the tuft using the testing apparatus (5,4.1.3).
Test two non-adjacent tufts of each type (If available).
5.7.1.3 StrIker for pendulum. made of hardened steel, with a cylindrical surface having a radios of curvature of (0.80 t 0,20) mm. with its axis horizontal and perpendicular to the plane of swing of the pendulum.
5.7.2 Procedure
Hold the toothbrush handle using the clamping unIt (571.1) with a clamping torque of (0.70 i 0,03) N m. Ensure that the tuft-hole plane (key item 1) ii perpendicular to the bottom plane of the damping unit (key item 5). The metal plate(s) can be used as the spacer to adjust the angle. Set the clamping unit on the Impact teeter so that the sInker edge can hit the toothbrush handle at the centre of the tuft-hole area (key Item 8) from the opposite side of th. tuft-hole surface (key Item 2).
The length, Li. between the top plane of the clamping unit (key item 3) and the centre of the tuft-hole area (key item 8)4 55mm. My curvature of the corners of the clamping unit shall not be taken into account for Li.
NOTE 1 The Impact velocity of the striker dependent on the helghi of tIre strikir at the beginning of the test, or the vertical distance of fall of the pendulum slr*ing edge, This height isa luncilon of the length of the pendulum arm and the angle of the arm at the beginning of the test. The velocity of the attire, edge Impact can be CalCUlated by the IciowIng equation:
V (2gb)05
wtiero
V is the velocity of the striker at the moment of Impact, in metres per second:
g is the local gravitational acceleration, in metres per second squared:
is the vertical distance of fall of the pendulum striking edge, in metres.
NOTE 2 ASTM 0256-4)6 sets the verlical distance of the pendulum slritung edge to be (610 ± 2.0) nwn. which will produce a velocity of the striking edge at the moment of Impact of approximately 3,5 mds.
Ensure that the distance between the line of contact of the pendulum striking edge and the centre of percussion of the pendulum is less than 2,54 mm
NOTE 3 ISO 13802 stales the the impact length shai be within I $ of the pendulum length. Since the pendulum length may vary with machines, the ASTSA D256-06 value of ±2.54 mm was chosen to be cont.nt across laboratories instead o(ths 1 %valuespscilledintSO 13802
Determine the pendulum length. Lp (3.9). in metres, from the penod of the osclatIon, Tp. in seconds, using the following equation.