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GB/T 37647-2019 English PDF (GBT37647-2019)

GB/T 37647-2019 English PDF (GBT37647-2019)

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GB/T 37647-2019: Toy and children product -- General principles for migration test of certain elements

This Standard specifies the sampling method, sample preparation and sample extraction method for the migration test of certain elements in toy and children product in the simulated human environment.
GB/T 37647-2019
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 97.200.50
Y 57
Toy and children product - General principles for
migration test of certain elements
ISSUED ON: JUNE 04, 2019
IMPLEMENTED ON: JANUARY 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of the PEOPLE Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Overview ... 7
5 Reagents and materials ... 7
6 Instruments ... 8
7 General principles for sweat migration test model ... 9
8 General principles for saliva migration test model ... 13
9 General principles for gastric juice migration test model ... 16
10 Test report ... 19
Appendix A (Informative) Selection guidance for migration test models ... 20 Appendix B (Informative) Selection guidance for test method (gravimetric method and area method) ... 25
Appendix C (Informative) Technical information of migration test model ... 28 References ... 30
Toy and children product - General principles for
migration test of certain elements
1 Scope
This Standard specifies the sampling method, sample preparation and sample extraction method for the migration test of certain elements in toy and children product in the simulated human environment.
This Standard applies to the pretreatment of migration test of certain elements, such as aluminum, antimony, arsenic, barium, boron, cadmium, chromium,
cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, zinc, in toy and children product in the simulated human environment (including sweat, saliva, and gastric juice environments). Migration tests of other certain elements can be performed with reference to this Standard after verification. This Standard does not apply to the toy or children product which is clearly excluded from the possibility of being sucked, licked, chewed, swallowed or exposed to the skin for a long term, due to its accessibility, function, mass, size or other characteristics, in consideration of children's normal use and foreseeable behavior.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 6675.1-2014, Toys safety - Part 1: Basic code
GB 6675.2, Safety of toys - Part 2: Mechanical and physical properties
GB 6675.4-2014, Safety of toys - Part 4: Migration of certain elements
GB/T 6682, Water for analytical laboratory use - Specification and test methods
3 Terms and definitions
Terms and definitions determined by GB 6675.1-2014, GB 6675.4-2014 and the following ones are applicable to this document. For ease of use, some of the 3.8 Reasonably foreseeable abuse
The possible way of use, which uses toy and children product in ways that are not recommended by the supplier, but may occur under normal circumstances, including the normal free behavior of children by combining toys and children products.
Examples: dismantle, drop, or use toy and children product in non-
recommended ways.
Note: Rewrite GB 6675.1-2014, definition 3.17.
3.9 Sample area
The area of the test sample, which is immersed in the test solution, that is in contact with the solution and is not covered.
3.10 Base material
The material, on which coating can form or adhere to the surface.
[GB 6675.4-2014, definition 3.1]
3.11 Coating
All material layers that are formed or attached to the base material of the toy and children product.
Examples: paint, varnish, lacquer, ink, polymer, metal particle or other similar substances that are attached to the base material.
Note: Rewrite GB 6675.4-2014, definition 3.2.
3.12 Paper and paperboard
Paper and paperboard whose maximum mass per unit area is not more than
400 g/m2.
Note: paper and paperboard whose mass per unit area exceeds 400 g/m2 shall be treated as "other materials", and may also be fiberboard or cardboard. [GB 6675.4-2014, definition 3.5]
3.13 Scraping
The mechanical process of separating the coating from the base material, which shall not scrap the base material.
[GB 6675.4-2014, definition 3.6]
5.5 Ammonia water: the mass fraction is 25%, ?? = 0.91 g/mL.
5.6 Dilute ammonia water: the mass fraction is 1%.
5.7 Sodium hydroxide (NaOH): c (NaOH) ??? 0.1 mol/L.
5.8 Magnesium chloride hexahydrate (MgCl2??6H2O).
5.9 Calcium chloride dihydrate (CaCl2??2H2O).
5.10 Dipotassium hydrogen phosphate trihydrate (K2HPO4??3H2O).
5.11 Potassium carbonate (K2CO3).
5.12 Potassium chloride (KCl).
5.13 Hydrochloric acid: the mass fraction is 37%.
5.14 N-heptane: chemically pure; the mass fraction is not less than 99%. 5.15 Hydrochloric acid solution: c (HCl) = (0.07 ?? 0.005) mol/L.
5.16 Hydrochloric acid solution: c (HCl) = (0.14 ?? 0.010) mol/L.
5.17 Hydrochloric acid solution: c (HCl) ??? 2 mol/L.
5.18 Hydrochloric acid solution: c (HCl) ??? 6 mol/L.
5.19 Hydrochloric acid solution: the mass fraction is 1%.
5.20 Unless otherwise specified, use only analytical reagents or reagents above the grade.
6??Instruments
6.1 Test sieve: plain stainless-steel wire mesh sieve; the rated aperture is 0.5 mm.
6.2 pH meter: the accuracy is not less than ?? 0.1pH unit; it shall be prevented from cross-contamination.
6.3 Membrane filter: the pore size is 0.22 ??m and 0.45 ??m.
6.4 Centrifuge: the centrifugal capacity is (5 000 ?? 500) g (g = 9.806 65 m/s2). 6.5 Constant-temperature oscillator: the temperature is constant at (37 ?? 2) ??C during oscillation; the oscillation frequency accuracy is not less than ??5 times/min.
physical separation methods (those caused by reasons such as dot dyeing, printing textiles or quality restrictions).
Note: It does not exclude the acquisition of any form of reference sample, as long as the reference sample can represent the relevant toy and children product material and the basic materials that are attached to them as
specified above.
If the material mass is 10 mg ~ 100 mg, it shall be processed and calculated as 100 mg of test sample. The sample whose mass is less than 10 mg can be
exempted from testing or tested by area method.
7.3.2 Sample preparation
7.3.2.1 Coating
At room temperature, adopt the method of scraping to obtain coating from the sample of toy and children product; pulverize the sample under the condition that does not exceed the ambient temperature. Obtain not less than 100 mg of coating test sample as much as possible from the materials that pass through a test sieve whose pore size is 0.5 mm (see 6.1).
For coatings that cannot be pulverized due to their own characteristics (such as elastic/ plastic paint), transfer the test sample directly from the sample without pulverizing the coating.
7.3.2.2 Other materials
Try to remove not less than 100 mg of test sample as much as possible; avoid material heating when removing. The test sample shall be cut from the smallest thickness of the material section, so as to ensure that the ratio of the test sample area to the test sample mass is as large as possible. The dimensions of each test sample in any direction shall not be greater than 6 mm in the uncompressed state.
If the material is spot-dyed or printed textile, the removed test sample shall be a representative sample of the overall material.
If there is a coating on the to-be-tested material, firstly remove the coating on the material according to the sampling procedure of 7.3.2.1; then, perform sampling on the base material.
If the material is liquid, no processing such as shredding is required; take samples directly.
7.3.3 Sample extraction
7.4.2.1 Coating
The base material and coating shall not be separated when preparing the test sample. When calculating the sample area, only calculate the area that is covered by the coating. If the sample is covered by the coating only on one side, only count the area of one side. The sample area of the taken test sample shall be larger than 1 cm2 as far as possible.
When taking a sample, cut the test sample from the minimum thickness of the base material section as far as possible, to ensure that the area of the base material is as small as possible, so as to reduce the impact on the coating test. For the sample which is covered with only one side of the coating, during the sample extraction process, certain elements in the extraction solution not only originate from the to-be-tested coating sample, but also from the base material, and the test results may be stricter than actual conditions.
When testing the coating sample, in order to avoid being affected by the base material, the non-tested surfaces can be wax-sealed.
7.4.2.2 Other materials
Remove a test sample of not less than 1 cm2 as far as possible; avoid heat or pressure on the material when removing. For the base material that is covered with a coating on the surface, use mechanical methods to remove the coating before preparing the sample.
Paints, coatings, and plating shall not be considered as barriers that render components that contain certain elements in toy and children product
inaccessible.
Considering that the incision will affect the test results, a complete sample shall be selected when preparing the sample. When cutting is required, choose the smallest thickness, as far as possible, for cutting. When the sample thickness is less than or equal to 0.5 mm, take the area of one side of the sample as the sample area; when the sample thickness is greater than 0.5 mm and less than or equal to 2 mm, take the sum of the areas of the front and back of the sample as the sample area; when the sample thickness is greater than 2 mm, take the sum of the areas of the front and back of the sample and the area of its side as the sample area.
For the sample that has inconsistent front and back materials, during the simultaneous test, only calculate the area of the accessible part of the to-be- tested material. In this case, the migrated certain elements may be from non- tested materials; therefore, the test results may be stricter than the actual conditions.
centrifuge (see 6.4) to separate. The centrifugation time shall not exceed 10 minutes, which shall be stated in the report.
9 General principles for gastric juice migration test
model
9.1 Overview
Use a certain volume of simulated gastric juice (see 9.2) to process the sample under specific migration conditions. See Appendix C for technical information on the preparation of the gastric juice migration test model.
9.2 Simulated gastric juice preparation
Take 900 mL of water (see 5.1) into a 1 000 mL conical flask; add 5.81 mL of hydrochloric acid (see 5.13); stir well; transfer the solution to a 1 000 mL volumetric flask; add water (see 5.1) to fix-volume to 1 000 mL. Use standard anhydrous sodium carbonate or other standard-calibrated solutions to titrate, to obtain accurate hydrochloric acid solution concentration. The concentration shall be (0.07 ?? 0.005) mol/L. This solution is a simulated gastric juice. If the mass fraction of the used concentrated hydrochloric acid is not 37%, the volume of added hydrochloric acid shall be recalculated.
9.3 Sampling
The test sample shall be taken from accessible parts of individual toy and children product. The same material on a single product can be combined as the same test sample; but the material of other samples shall not be used at the same time. The test sample shall not contain more than one material or more than one color, unless the sample cannot be effectively separated by physical separation methods.
Example: physical separation methods which cannot be used for effective separation due to dot dyeing, printing textiles, or quality restrictions. Note: it does not exclude the acquisition of any form of reference sample, as long as the reference sample can represent the relevant toy and children product material and the basic materials that are attached to them as
specified above.
If the material mass is 10 mg ~ 100 mg, it shall be processed and calculated as 100 mg of test sample. The sample whose material mass is less than 10 mg can be exempted from testing.
9.4 Sample preparation
a coating on the to-be-tested material, firstly remove the coating on the material; then, perform sampling on the base material. The test sample shall be cut from the smallest thickness of the material section, so as to ensure that the ratio of the test sample area to the test sample mass is as large as possible.
9.5 Sample extraction
9.5.1 Glass, ceramic, metal materials
Put toy and children product or their components into a 50 mL glass container; the nominal size of the container is: height of 60 mm, diameter of 40 mm. Add simulated gastric juice (see 9.2) at room temperature, so that the solution can just immerse the test sample. Cover the container; protect it from light; place it at a temperature of (37 ?? 2) ??C for 2 h. Then, immediately separate the solids in the mixture effectively by filtration. If necessary, use a membrane filter (see 6.3) or a centrifuge (see 6.4) to separate. The centrifugation time shall not exceed 10 minutes, which shall be stated in the report.
9.5.2 Other materials
Use a suitable extraction container (see 6.6); mix the simulated gastric juice 50 times the mass of the test sample AND the test sample at room temperature. Shake for 1 min and check the acidity of the mixture. If the pH value is greater than 1.5, then, add dropwise hydrochloric acid solution (see 5.17) whose concentration is about 2 mol/L, until the pH value of the mixture reaches the range of 1.0 ~ 1.5. In a constant-temperature oscillator (see 6.5) at (37 ?? 2) ??C, avoid light; continue to oscillate for 1 h; then, leave it at (37 ?? 2) ??C for 1 h. Then, immediately separate the solids in the mixture effectively by filtration. If necessary, use a membrane filter (see 6.3) or a centrifuge (see 6.4) to separate. The centrifugation time shall not exceed 10 minutes, which shall be stated in the report. Immediately perform elemental analysis test of the filtrate. For materials which contain grease, oils, waxes or similar materials, a dewaxing process shall be performed. Wrap the test sample in hard filter paper; before the extraction process, use n-heptane (see 5.14) or other suitable solvent extraction to remove the above components. Use appropriate analytical
methods to ensure that the removal of these components is quantitative. The solvent that is used shall be stated in the report as required. After the wax is removed, leave the test sample on the hard filter paper; perform extraction of the hard filter paper and the test sample together. Use the original test sample mass to calculate the simulated gastric juice volume.
For paper, paperboard, and test samples that have been dewaxed, first add water (see 5.1) 25 times the mass of the test sample to soak the test sample; then, add hydrochloric acid solution (see 5.16), of which the mass is 25 times of the test sample and the concentration is 0.14 mol/L.
Appendix A
(Informative)
Selection guidance for migration test models
A.1 Overview
In order to use this Standard reasonably, it is necessary to understand the migration of certain elements in toy and children product in the body fluid environment. The way and degree of migration of certain elements to the human body are related to the way children use products and the characteristics of certain elements. The migration test models in this Appendix include sweat migration that is caused by contact of toy or children products with the skin, saliva migration that is caused by contact with the mouth, and gastric juice migration that is caused by swallowing. Related studies have confirmed that gastric juice migration capacity is often greater than sweat migration and saliva migration capacity.
A.2 Theoretical basis for sweat migration test model
Most toys and children products will have skin contact with users. For example, pencils and toys will intermittently or continuously come into contact with hands during use; children clothing will continue to come into contact with body skin during the wearing stage; children metal jewelry has been in prolonged contact with skin of specific parts of the body. Because human skin secretes sweat, the product material will be infiltrated to a certain extent when in contact with the skin, and certain elements in the material will be migrated out into the human sweat, and there is a potential risk of being absorbed by the body. Therefore, sweat migration is a common way that certain elements may enter the body. A.3 Theoretical basis for saliva migration test model
Oral contact mainly includes actions such as sucking, licking, and chewing. Some children products on the market are specially designed for oral use, such as teething rings for children's bites, pacifiers for oral sucking. The products that are involved in oral behavior include a wide range; in addition to products which are specifically used for the mouth, it also includes other products that are easy to be bitten by children due to abuse, such as pens; although their size is too large to be completely put in the mouth, the raised part will still be bitten by children. In children's oral behavior, the product material will be infiltrated by saliva, and certain elements in the material will migrate out into the saliva of the human body, and there is a potential risk of being absorbed by the human body. Therefore, saliva migration is a common way that certain elements may enter the body.
a) Whether the children play mat be directly ingested? No, the infant play mat is large enough, and it is not a small part that can be ingested directly. It?€?s unnecessary to consider branch 1.
b) Whether it can come into contact with the mouth? Yes, the corners of the play mat can come into contact with the mouth. It?€?s necessary to consider branch 2. Whether it is easy to fall off due to biting when it comes into contact with the mouth? Yes, it is necessary to consider the gastric juice migration and the saliva migration.
c) Whether it can come into contact with the hands? Yes, the baby may crawl on the play mat and it is very likely to come into contact with the hands. It?€?s necessary to consider branch 2. However, its materials are not easy to remain on the hands; it?€?s necessary to consider sweat migration.
d) Whether it can come into contact with other parts of the body? Yes, infants may crawl or lie down on the play mat, and face, arms (which may be bare) and feet may be exposed; it?€?s necessary to consider branch 4.
According to the evaluation results, there may be sweat migration, saliva migration, and gastric juice migration in the use of children floor mat. Note that when using the migration test model evaluation figure, it is important to reasonably evaluate all possible occurrences of normal use and reasonable abuse of the product; do not miss any exposure patterns.
A.5.2 Examples of migration test model selection
A.5.2.1 Paperboard jigsaw puzzle for children under three
For the paperboard jigsaw toy product, it shall choose the gastric juice migration test model. According to the analysis in Figure A.1, toy products have three types of migration at the same time. Considering that the migration capacity of certain elements in gastric ...

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