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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by the Guangdong Medical Devices Management Academy.
This standard is under the jurisdiction of the Guangdong Medical Devices Management Academy.
Attention is drawn to the possibility that some of the elements of this document 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.
Single-use face mask for children
1 Scope
This standard specifies the classification, requirements, test methods, and marking, instructions for use, packaging and transport of single-use face mask for children (hereinafter referred to as “mask”).
This standard is applicable to single-use face masks worn by children aged 3-14 years in daily medical environment to block exhaled or expelled pollutants from the oral cavity and nasal cavity.
This standard is not applicable to masks with breather valves.
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/T 2912.1 Textiles - Determination of formaldehyde - Part 1: Free and hydrolyzed formaldehyde (water extraction method)
GB/T 7573 Textiles - Determination of pH of aqueous extract
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 15979-2002 Hygienic standard for disposable sanitary products
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
GB/T16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
YY 0469-2011 Surgical mask
YY/T 0969-2013 Single-use medical face mask
3 Classification
3.1 Masks are classified as sterilized and non-sterilized types according to whether they are sterilized or not.
3.2 Masks are classified as flat and 3D types by shapes.
4 Requirements
4.1 Appearance and sensory requirements
4.1.1 The appearance of the mask shall be clean and in good shape, and the surface shall not be free of any damage, stain, burr or sharp edge.
4.1.2 The wearing directions (inside, outside, up and down) of the mask shall be clearly distinguished and should be marked with words, colors, patterns or other appropriate methods.
4.1.3 Masks shall be free of peculiar smell.
4.2 Structure and dimensions
4.2.1 The mask shall be able to cover the mouth, nose and lower jaw of the wearer after it is properly put on. It shall comply with nominal dimensions, and the maximum deviation shall not exceed ±1cm.
4.2.2 See Table 1 for the recommended specifications and dimensions of flat masks.
Table 1 Recommended specifications and dimensions of flat masks
In cm
Mask specification Length × width
Large size 14.0×9.0
Small size 12.0×7.0
4.3 Nose clip
4.3.1 Flat masks shall be equipped with nose clips.
4.3.2 3D masks may be attached to the face by nose clips or other means.
4.3.3 Nose clips shall be made of malleable materials and shall not be exposed, with length not less than 6.0cm.
4.4 Mask strips
4.4.1 Masks shall be worn and taken off conveniently, and earloop design should be adopted.
4.4.2 Mask strips should be made of elastic, soft and comfortable materials.
4.4.3 The breaking strength at the connection point between mask strip and mask body shall not be less than 10N.
4.5 Filtration efficiency
4.5.1 Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency (BFE) of masks shall not be less than 95%.
4.5.2 Particle filtration efficiency (PFE)
The non-oily particle filtration efficiency of masks shall not be less than 80%.
4.6 Air penetration resistance
The air penetration resistance for air exchange of both sides of the mask shall not be greater than 40Pa/cm2.
4.7 Microbial indexes
4.7.1 Non-sterilized masks shall meet the requirements specified in Table 2.
Table 2 Microbial indexes of non-sterilized masks
Total bacterial count(CFU/g) Coliforms Pseudomonas aeruginosa Staphylococcus aureus Streptococcus hemolyticus Fungus
≤100 Undetectable Undetectable Undetectable Undetectable Undetectable
4.7.2 Sterilized masks shall be sterile.
4.8 Residual quantity of ethylene oxide
If the mask is sterilized or disinfected with ethylene oxide, the residual quantity of ethylene oxide shall be not greater than 10μg/g.
4.9 Biological evaluation
4.9.1 Cytotoxicity
The cytotoxicity of the mask shall be Grade 2 or below.
4.9.2 Skin irritation
The primary irritation score of the mask shall not exceed 0.4.
4.9.3 Sensitization response
The mask shall not cause sensitization response.
4.10 Formaldehyde content (if applicable)
The content of formaldehyde in the outer layer of the mask shall not exceed 20mg/kg.
4.11 pH value (if applicable)
The pH value of the mask shall be between 4.0 and 7.5.
5 Test methods
5.1 Appearance and sensory tests
Take three samples randomly to carry out the test. Carry out visual and sensory inspections.
5.2 Structure and dimensions
Take three samples randomly to carry out the test. Wear them as in actual use and measure them with a general or special measuring tool.
Foreword i
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Test methods
6 Marking, instructions for use, packaging and transport
