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T/CTCA 7-2019 PDF in English


T/CTCA 7-2019 (T/CTCA7-2019, TCTCA 7-2019, TCTCA7-2019)
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T/CTCA 7-2019: PDF in English (TCTCA 7-2019)

T/CTCA 7-2019 ASSOCIATION STANDARD ICS 59.080.30 W 55 Ordinary Protective Mask ISSUED ON: DECEMBER 31, 2019 IMPLEMENTED ON: JANUARY 30, 2020 Issued by: China Textile Commerce Association Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative References ... 4  3 Terms and Definitions ... 5  4 Basic Requirements ... 5  5 Technical Requirements ... 5  6 Test Methods ... 7  7 Inspection Classification and Rules ... 8  8 Packaging and Marking ... 9  9 Storage and Transportation ... 10  Ordinary Protective Mask 1 Scope This Standard specifies the terms and definitions, basic requirements, technical requirements, test methods, inspection rules, marking, label, packaging, transportation and storage of ordinary protective mask (hereinafter referred to as mask). This Standard is applicable to protective masks worn in daily life to filter out pollen, catkins, bacterial particulates, and to block contaminants exhaled or sprayed from the nasal cavity or mouth. This Standard is applicable to general protective masks, such as: disposable protective flat-face masks, gauze masks and fashion masks. This standard does not apply to respiratory protection products that are used for special industries such as oxygen-deficient environment, underwater operation, escape, fire protection, medical and industrial use; it also does not apply to infant respiratory protection products. 2 Normative References The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 191 Packaging - Pictorial Marking for Handling of Goods GB 19083 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 6 Test Methods 6.1 Appearance Inspection Take 10 masks; adopt visual inspection method for the inspection. The inspection light shall be subject to normal natural light. When it is illuminated with a fluorescent lamp, the illuminance shall be not lower than 400 lx. 6.2 Formaldehyde Content Comply with the stipulations of GB/T 2912.1. 6.3 pH Value Comply with the stipulations of GB/T 7573. The sample is taken from the contact layer between the mask and the human face. 6.4 Residual Ethylene Oxide In accordance with product marking, masks treated with ethylene oxide shall comply with the stipulations of Chapter 9 in GB/T 14233.1-2008. Take parallel samples for the test. The samples shall be cut from the mask body. If the test is one-sample pass and one-sample fail, then, it shall not be calculated on the average, instead, it shall conduct re-sampling for the test; take the highest value as the test result. The result calculation shall be expressed in relative content; retain one decimal place. 6.5 Filter Efficiency a) Bacterial filtration efficiency (BFE) shall comply with the stipulations of 5.6.1 in YY 0469-2011. b) Particulate filtration efficiency (BFE) shall comply with the stipulations of 5.6.2 in YY 0469-2011. 6.6 Ventilation Resistance In accordance with the stipulations of 5.6.2 in YY 0469-2011, test particulate filtration efficiency (PFE), simultaneously, record the ventilation resistance of the samples. 6.7 Breaking Strength of Mask Tape and Connection between Mask Tape and Mask Body Comply with the stipulations of 5.4 in YY 0469-2011. 6.8 Microbiological Index Comply with the stipulations of GB 15979. 7.5 Exit-factory inspection items are appearance, particulate filtration efficiency, headband tension, ventilation resistance and residual ethylene oxide (if applicable). 7.6 Quality Determination 7.6.1 Determination of appearance quality When all the samples comply with the requirements in 5.2 in appearance quality, then, they shall be determined as qualified, otherwise, they shall be determined as disqualified. 7.6.2 Determination of intrinsic quality When all the samples comply with the requirements in Table 1 in intrinsic quality, then, they shall be determined as qualified, otherwise, they shall be determined as disqualified. 7.6.3 Determination of result When all the samples are qualified in appearance quality and intrinsic quality, then, this batch of products shall be determined as qualified, otherwise, they shall be determined as disqualified. 8 Packaging and Marking 8.1 Packaging The smallest sales unit shall be in sealed package. 8.2 Marking Each packaging unit shall have an inspection certificate. In addition, the obvious parts shall be attached with a clearly identifiable specific marking of GROUP STANDARD. The marking shall include the following content: a) The name and address of the manufacturer; b) Product name; c) Main raw material (inner layer, outer layer, filter material); d) Serial No. of implemented standard; e) Product specification; f) Instructions of use (wearing method and precautions, etc.); g) Date of production; ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.