T/CTCA 7-2019 in English

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This standard is developed in accordance with the rules given in GB/T 1.1-2009 Directives for standardization—Part 1: Structure and drafting of standards.

This standard was proposed by the China Textile Commerce Association.

This standard is under the jurisdiction of the Safety & Health Goods Committee of China Textile Commerce Association.

Ordinary protective mask

1 Scope

This standard specifies terms and definitions, basic requirements, specifications, test methods, inspection rules, marking, labeling, packaging, transportation and storage for ordinary protective masks (hereinafter referred to “mask”).

This standard is applicable to protective masks intended to filter out pollen, catkins, bacterial particles and to block exhaled or ejected pollutants from nasal cavity or oral cavity in daily life use.

This standard applies to general purpose protective masks such as disposable flat masks, gauze masks, fashion masks for general protection.

This standard is not applicable to respiratory protective equipment for special industry uses such as anoxic environment, underwater operation, escape, fire fighting, medical and industrial application, and is not applicable to respiratory protective equipment for baby and infant uses.

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 191 Packaging—Pictorial marking for handling of goods
GB19083 Technical requirements for protective face mask for medical use
GB 2890 Respiratory protection—Non-powered air-purifying respirators
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 equipment for medical use—Part 1: Chemical analysis methods
GB 15979 Hygienic standard for disposable sanitary products
YY 0469 Surgical mask
GB/T 17593.2 Textiles—Determination of heavy metals—Part 2: Inductively coupled plasma atomic emission spectrometry

3 Terms and definitions

3.1
filter efficiency
the percentage of particles filtered out through the mask or filter element (filter material) under specified test conditions

[GB 2626-2006, Definition 3.16]

3.2
bacterial filtration efficiency
the percentage of bacteria-containing suspended particles filtered out by the face mask material at the specified flow rate

[ASTM F2101-07, Definition 3.1.4]

4 Basic requirements

4.1 General

4.1.1 The appearance style and functional structure of the mask shall be so designed as to meet the requirements of processing technology and personalized customization.

4.1.2 The raw materials for masks shall not use recycled materials and known materials that can cause skin irritation or other adverse reactions. The residual amount of other restricted substances shall meet the relevant requirements and there shall be no odor.

5 Specifications

5.1 General

5.1.1 The mask shall be able to safely and securely cover the mouth and nose.

5.1.2 The mask shall not have any accessible sharp points or sharp edges and shall not cause any harm to the wearer.

5.1.3 The mask shall be easy to wear and remove, and, in as worn condition, pose no obvious pressure or tenderness and have inconsiderable influence on the head movement.

5.2 Appearance

5.2.1 The mask surface shall be free from damage, oil stain, deformation and other obvious defects.

5.3 Inherent quality

The inherent quality indexes shall meet the requirements of Table 1.

Table 1 Inherent quality
Index Requirement
Formaldehyde content/(mg/kg) ≤ 20
pH value 4.0~7.5
Ethylene oxide residue a/(μg/g) ≤ 10
Bacterial filtration efficiency (BFE)/% ≥ 95
Particulate filtration efficiency (PFE)/% ≥ 80
Breathing resistance/Pa ≤ 80
Breaking strength of the mask strip and the connection between mask strip and mask body /N ≥ 10
Heavy metal content/mg/kg Arsenic ≤ 0.2
Cadmium ≤ 0.1
Cobalt ≤ 1.0
Chromium ≤ 1.0
Copper ≤ 25.03
Nickel ≤ 1.0
Lead ≤ 0.2
Antimony ≤ 30.0
Microbial index Coliform Absent
Pathogenic pyogenic bacteria b Absent
Total fungal colony count/(CFU/g) ≤ 100
Total bacterial count/(CFU/g) ≤ 200
Lower field of vision ≥ 60°
a Only masks treated with ethylene oxide are to be tested.
b It includes Pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus.
For fashion masks, the items of ethylene oxide residue, bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE) and breathing resistance do not apply.

6 Test methods

6.1 Appearance inspection

Ten masks were sampled and tested by visual inspection. The inspection shall be carried out under normal natural light. If a fluorescent lamp is applied, its illuminance shall not be less than 400 lx.

6.2 Formaldehyde content

It shall comply with GB/T 2912.1.

6.3 pH value

It shall comply with GB/T 7573. The specimens shall be cut off from the face of the mask contacting human face.

6.4 Ethylene oxide residue

As indicted in the product marking, for masks treated with ethylene oxide, it shall be tested according to Clause 9 of GB/T 14233.1-2008. Parallel samples shall be taken for testing, and cut from the mask body. If the test result of one series is acceptable but that of the other not, the average of the two series shall not be used. Another sample shall be taken and retested and the largest value shall be considered as the test result. The calculated result is expressed by relative content, with one decimal place reserved.

6.5 Filter efficiency

a) Bacterial filtration efficiency (BFE) shall comply with 5.6.1 in YY 0469-2011.

b) Particulate filtration efficiency (PFE) shall comply with 5.6.2 in YY 0469-2011.

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Basic requirements
5 Specifications
6 Test methods
7 Inspection classification and inspection rules
8 Packaging and marking
9 Storage and transportation