Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces the compulsory contents related to safety in GB 19342-2013 Toothbrushes, GB30002-2013 Child's toothbrushes and GB 30003-2013 Toothbrushes with tapered filament. Compared with the compulsory contents in these three standards, the following main technical changes have been made as follows:
——The requirements of "tapered filament" in "bristle safety of toothbrush” have been changed (see 5.6.3.2, 5.5 of GB 30003-2013);
——The requirements of "edge and tip" have been changed (see 5.7, 4.2.1 of GB 19342-2013, 4.2.1 of GB 30002-2013 and 5.2.1 of GB 30003-2013);
——The requirements of "child's toothbrushes and oral implement accessories" have been changed (see 5.8, 4.7 of GB 30002-2013);
——Annex A has been added to indicate the correspondence between compulsory contents in the new and old versions.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by and is under the jurisdiction of the Ministry of Industry and Information Technology of the People's Republic of China.
The previous editions replaced by this standard are as follows:
——GB 19342-2003, GB 19342-2013;
——GB 30002-2013;
——GB 30003-2013.
General technical requirements for safety of toothbrushes and oral implements
1 Scope
This standard specifies the terms and definitions, product classifications, requirements and test methods for toothbrushes and oral implements (hereinafter referred to as "products").
This standard is applicable to toothbrushes and oral implements for daily cleaning and care.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 4706.1-2005 Household and similar electrical appliances—Safety—Part 1: General requirements
GB 4706.59 Household and similar electrical appliances—Safety—Particular requirements for oral hygiene appliances
GB 5009.34-2016 National food safety standard—Determination of sulfur dioxide in foods
GB 6675.2-2014 Safety of toys—Part 2: Mechanical and physical properties
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 22048 Determination of certain phthalate esters in toys and children’s products
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
brush head
one end of a toothbrush with bristles
3.2
filament
single thin piece in a bristle
3.3
tuft
aggregation of a set of filaments
3.4
tufting block
movable small components with tuft in the brush head of an electric toothbrush
3.5
molded bristle toothbrush
toothbrush whose bristles are all molded into one piece
Note: a single bristle is regarded as a tuft
3.6
tapered filament
filament with a conical tip
3.7
endrounding filament
filament whose top is processed to remove sharp angle and thorn
3.8
removable component
parts or components on a product that are intended to be removed without tools
Note: it is a revision of Definition 3.43 in GB 6675.2-2008
3.9
accessory1)
accessory as a small part
4 Product classifications
4.1 Toothbrushes may be classified in the following ways:
——According to the applicable population, it may be classified into adult’s toothbrushes and child’s2) toothbrushes;
——According to the toothbrush production process, it may be classified into molded bristle toothbrushes and tufting toothbrushes. The tufting toothbrushes are classified according to the treatment process of bristle top, including but not limited to endrounding filament toothbrushes and tapered filament toothbrushes;
——According to the driving mode, it may be classified into electric toothbrushes and manual toothbrushes.
4.2 Oral implements may be classified into interdental brushes, oral irrigators (water picks), tongue scrapers, toothpicks, dental flosses, dental floss sticks, teeth grinding implements for babies and infants, etc.
5 Requirements
5.1 General
The products shall not cause harm to human body under normal or reasonably foreseeable service conditions.
5.2 Phthalate ester plasticizer
5.2.1 Safe plastic additives shall be used in child's products. The contents of six plasticizers (DBP, BBP, DEHP, DNOP, DINP, DIDP) of plasticized materials at the entrance and accessible parts shall not exceed the limit requirements specified in Table 1.
5.2.2 Safe plastic additives shall be used in adult’s products. The content of six plasticizers (DBP, BBP, DEHP, DNOP, DINP, DIDP) of the plasticized material at the entrance shall not exceed the limit requirements specified in Table 1.
Table 1
Limit plasticizer category and corresponding CAS number Limit /%
Dibutyl phthalate (DBP) CAS 84-74-2 The total content of the three plasticizers is not more than 0.1
Butyl benzyl phthalate (BBP) CAS 85-68-7
Di(2-ethylhexyl)phthalate (DEHP) CAS 117-81-7
Di-n-octyl phthalate (DNOP) CAS 117-84-0 The total content of the three plasticizers is not more than 0.1
Diisononyl phthalate (DINP) CAS 68515-48-0
CAS 28553-12-0
Diisodecyl phthalate (DIDP) CAS 26761-40-0
CAS 68515-49-1
Note: Exemption shall be given when the sampling amount of a single specimen is less than 10mg.
5.3 Harmful elements
The content of such elements as soluble stibonium, arsenic, barium, cadmium, chromium, plumbum, mercury and selenium or any soluble compound composed of these elements in the product shall not exceed the values specified in Table 2.
Table 2 Unit: mg/kg
Name of element Stibium (Sb) Arsenic (As) Barium (Ba) Cadmium (Cd) Chromium (Cr) Plumbum (Pb) Hydrargyrum (Hg) Selenium (Se)
Content 60 25 1000 75 60 90 60 500
5.4 pH of tapered filament bristles
The pH range of the tapered filament bristles is 5.5 ~ 8.0.
5.5 Release of sulfur dioxide in wooden and bamboo toothpicks
The release of sulfur dioxide in wooden and bamboo toothpicks shall not exceed 600mg/kg (calculated as SO2).
5.6 Safety performance of toothbrushes
5.6.1 Toothbrush tuft tension and neck bending resistance
Toothbrush tuft tension and neck bending resistance shall meet the requirements in Table 3.
Table 3 Unit: N
No. Item Requirement
Adult’s toothbrush Child's toothbrush
1 Toothbrush tuft tension ≥15
2 Neck bending resistance ≥43 or continuously within the deformation limit range ≥25 or continuously within the deformation limit range
Note 1: Toothbrush tuft tension is not measured in the molded bristle toothbrush.
Note 2: Neck bending resistance is not measured in the electric toothbrush
5.6.2 Brush heads of child's toothbrushes3)
Heads of Child's toothbrushes shall not be removed.
5.6.3 Safety of toothbrush bristles
5.6.3.1 Endrounding filament
The sharp angle shall be removed from the top outline of endrounding filament after endrounding, and there shall be no burr. Examples of acceptable and nonconformity filament top outline are shown in Figure 1a) and Figure 1b). The qualification rate of filament top outline shall meet the requirements of Table 4.
a) acceptable filament top outline b) nonconformity filament top outline
Figure 1
Table 4
Item Requirement
Adult’s toothbrush Child's toothbrush
The qualification rate of filament top outline /% Flat-bristle type ≥60 ≥70
Irregular-bristle type ≥40 ≥50
5.6.3.2 Tapered filament
The qualification rate of filament diameter at the tip of tapered filament shall meet the requirements of Table 5.
Table 5
Item Requirement
Qualification rate of diameter of tapered filament 0.01mm away from the top of the filament At least 70% of the filaments are not greater than 0.04mm in diameter
0.5mm away from the top of the filament At least 90% of the filaments are not larger than 0.08 mm in diameter
5.6.3.3 Others
Other bristles shall be evaluated for safety whether they will damage gums.
5.6.4 Electrical safety requirements
Electrical parts and related accessories shall meet the requirements specified in GB 4706.1-2005 and GB 4706.59.
5.6.5 Firmness of electric toothbrush tufting block
For electric toothbrushes with tufting block structure, the connection firmness between the tufting block and the brush head shall be no less than 50N.
5.6.6 Chemical resistance of electric toothbrushes
After the test in 6.5.6, the brush head shall meet the requirements of elastic impact test in clause 21 of GB 4706.1-2005; the brush head shall be able to be used continuously and its surface shall be smooth .
5.6.7 Removable components of child's electric toothbrushes
For child's electric toothbrushes whose age range is indicated on the sales package, its removable components shall meet the requirements of 4.4.1 or 4.4.2 in GB 6675.2-2014 according to the indicated age stage; for child's electric toothbrushes whose age range is not indicated on the sales package, its removable components shall meet the requirements of 4.4.1 in GB 6675.2-2014.
5.7 Edges and tips
Products shall not have sharp edges, burrs and other defects, except for functional tips.
5.8 Child's toothbrushes and accessories for oral implements
5.8.1 The connection firmness of non-removable accessories shall be greater than or equal to 70N.
5.8.2 For child's products whose age range is indicated on the sales package, its removable accessories shall meet the requirements of 4.4.1 or 4.4.2 in GB 6675.2-2014 according to the indicated age stage; for child's products whose age range is not indicated on the sales package, its removable accessories shall meet the requirements of 4.4.1 in GB 6675.2-2014.
6 Test method
6.1 Phthalate ester plasticizer
It shall be tested according to the method specified in GB/T 22048.
6.2 Harmful elements
Test according to the method specified in Annex B.
6.3 pH of tapered filament bristles
Test according to the method specified in Annex C.
6.4 Release of sulfur dioxide in wooden and bamboo toothpicks
Test according to GB 5009.34-2016. Take 5g ~ 10g of specimen (accurate to 0.01g) and control the distillation time for 15min.
6.5 Safety performance of toothbrushes
6.5.1 Toothbrush tuft tension and neck bending resistance
6.5.1.1 Tuft tension
6.5.1.1.1 Test device: tension tester (the minimum division value is 0.1N), brush head clamp and bristle holder.
6.5.1.1.2 Specimen preparation: leave a bundle of bristles for each toothbrush, and remove other bristles. At the temperature of (20±5)°C, the temperature is constant for 4h.
6.5.1.1.3 Test conditions: temperature (20±5)°C, up-and-down speed of tension tester is (90±10) mm/min.
6.5.1.1.4 Test steps: connect the brush head to the lower jaw of the tension tester through the brush head clamp (with bristles upward), connect the bristle clamp to the upper jaw of the tension tester, and align and clamp the remaining tuft (see Figure 2). Start the tension tester and read the reading of the tension tester when the tuft falls off.
Keys:
1——lower jaw;
2——brush head clamp;
3——bristle holder;
4——upper jaw;
5——specimen;
Figure 2
6.5.1.2 Neck bending resistance
6.5.1.2.1 Test device: tension tester (the minimum division value is 0.1N), wire brush and brush handle clamp.
6.5.1.2.2 Specimen preparation: for adult’s toothbrushes, the first mark is made from the top of the head to 15mm, and the second mark is made from 65mm away from the first mark (see Figure 3); for child's toothbrushes, the first mark is made from the top of the head to 10mm, and the second mark is made from 65mm away from the first mark (see Figure 4). At the temperature of (20±5)°C, the temperature is constant for 4h.
6.5.1.2.3 Test conditions: temperature (20±5)°C, up-and-down speed of tension tester is (100±10) mm/min.
6.5.1.2.4 Test steps: put the steel wire with a diameter of 2mm and a length of about 250mm into the upper jaw of the tension tester for clamping, put the brush handle into the brush handle clamp and fix it at the second mark (with bristles downward), connect the brush handle clamp in the lower jaw of the tension tester, and cover the steel wire at the first mark (see Figure 3 for adult’s toothbrushes and Figure 4 for child's toothbrushes). Start the tension tester and read the reading when specimen fracturing or stop loading when bending to the limit.
Keys:
1——upper jaw;
2——steel wires;
3——brush handle clamp;
4——lower jaw;
5——specimen;
Figure 3
Keys:
1——upper jaw;
2——steel wires;
3——brush handle clamp;
4——lower jaw;
5——specimen;
Figure 4
6.5.2 Child's toothbrush head
Visual inspection and hand feeling inspection.
6.5.3 Safety of toothbrush bristles
6.5.3.1 Endrounding filament
6.5.3.1.1 Take three bundles of filaments randomly from the bristles of a flat-bristle toothbrush, then take them off and stick them on paper, observe them with a microscope more than 30 times, and calculate the qualification rate according to Equation (1).
6.5.3.1.2 Take one bundle from the high, middle and low bristle bundles of the irregular-bristle toothbrush, take off these three bundles of filaments, stick them on the paper, and observe them with a microscope more than 30 times. The filaments whose top outline meets the requirements are counted as acceptable filaments, and the qualification rate is calculated according to Equation (1).
(1)
where,
a——the qualified rate, %;
n——the number of acceptable filaments;
m——the total number of filament specimens.
6.5.3.2 Tapered filament
Take three bundles of tapered filament on one toothbrush, then randomly take 10 tapered filament from each bundle and stick them on the paper. Measure the filament diameters at 0.01mm and 0.5mm from the top of the tapered filament by a microscope with a minimum division value of 0.001mm. The filaments are counted as acceptable filaments if the filament diameters meet the requirements, and calculate the qualification rate according to Equation (1).
6.5.4 Electrical safety requirements for electric toothbrushes
It shall be tested with the method specified in GB 4706.1-2005.
6.5.5 Firmness of electric toothbrush tufting block
Fix one end of the brush head with a clamp, and stretch the end of the tufting block in the direction perpendicular to the surface with a force measuring device (see Figure 5 for schematic diagram). Stop loading when the tufting block is separated from the brush head or has not been separated until it reaches 50N or more, and record the displayed value.
Keys:
1——tufting block.
Figure 5
6.5.6 Chemical resistance of electric toothbrushes
6.5.6.1 Apparatus and reagents
6.5.6.1.1 Equipment used for preparing chemical reagents, such as stirring rod or mixer.
6.5.6.1.2 Containers, such as polypropylene plastic bottles, may be sealed without chemical reaction.
6.5.6.1.3 Electronic balance, with a precision of 0.001g;
6.5.6.1.4 See Table 6 for the minimum purity and dosage of chemical reagents.
Table 6
Reagents Minimum purity Dosage /g
Ethanol 98.5% 100
L-carvone 98.0% 1.5
LMenthol 98.0% 1.5
Sodium lauryl sulfate 95.0% 15.0
Glycerol 98.0% 200
Water GB/T 6682-2008, iii grade 682
6.5.6.2 Test steps
Put 1.5g L-carvone, 1.5g L-menthol, 15g sodium lauryl sulfate and 100g ethanol into the container (6.5.6.1.2), and mix them well with mixer (6.5.6.1.1). Add 250g water, mix well, add 200g glycerol and 432g water after clarification, and mix well to obtain a clear solution.
Put the removed brush head into the above solution. Make sure that at least 80% of the length of the brush head is immersed in the solution (the bristle part is facing down). If the brush head is not removable, immerse the brush head side at least 6cm in the solution, soak it in a sealed container for 24h, then gently take out the toothbrush, wash it with water, and throw off the excess water. Carry out elastic impact test as described in clause 21 of GB 4706.1-2005.
6.5.7 Removable components of child's electric toothbrushes
It shall be tested according to the method specified in 5.2 of GB 6675.2-2014.
6.6 Edges and tips
Visual inspection 300mm away from the products under natural light or 40W light, and check with hand feeling inspection.
6.7 Child's toothbrushes and accessories for oral implements
6.7.1 Non-removable accessories shall be tested according to the method specified in 5.24.6 of GB 6675.2-2014.
6.7.2 Removable accessories shall be tested with the method specified in GB 6675.2-2014.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Product classifications
5 Requirements
6 Test method
Annex A (Informative) The correspondence between compulsory contents in new and old editions
Annex B (Normative) Test method of harmful elements
Annex C (Normative) Test method for pH of tapered filament bristles
