GB/T Translated English of Chinese Standard: GB/T NATIONAL STANDARD OF THE

Transcription

1 Translated English of Chinese Standard: GB/T GB NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA ICS W 55 GB/T Technical specification of daily protective mask 日常防护型口罩技术规范 Issued on: April 25, 2016 Implemented on: November 1, 2016 Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People s Republic of China; Standardization Administration of the People s Republic of China. Page 1 of 23

2 Table of Contents Foreword Scope Normative references Terms and definitions Grading Technical requirements Test methods Inspection rules Packaging, marking, storage and transportation Annex A (normative) Test method for filter efficiency Annex B (normative) Test method for particle protective performance Annex C (informative) Wear environments and precautions of masks Bibliography Page 2 of 23

3 Foreword This Standard is drafted in accordance with the rules given in GB/T This Standard is proposed by China National Textile and Apparel Council. This Standard is under the jurisdiction of National Technical Committee Textiles of Standardization Administration of China (SAC/TC 209). Drafting organizations of this Standard: China Nonwovens and Industrial Textiles Association, Jiangsu Quality Supervision and Inspection Center for Special Type Products of Safety Protecting, Beijing Municipal Institute of Labor Protection, Shanghai Sinotextiles Corporation Limited, Beijing Institute of Medical Device Testing, Donghua University, Tianjin Teda Filters Co., Ltd., Institute of Urban Environment under Chinese Academy of Sciences, Guangzhou Fiber Product Testing and Research Institute, Winner Medical Co., Ltd., Shenzhen Selen Science and Technology Co., Ltd., Unicharm Daily Necessities (China) Co., Ltd., Shenyang Baianda Personal Protective Equipment Co., Ltd., Yunnan Baiyao Group Co., Ltd., Honeywell Personal Protective Equipment (Shanghai) Co., Ltd., Kimberly-Clark (China) Co., Ltd., Foshan Nanhai Beautiful Medical Device Co., Ltd., Xinlong Holding (Group) Co., Ltd., Fujian Zhongrui Environmental Protection Technology Co., Ltd., Yuchuan Health Products (Shanghai) Co., Ltd., Wuhan Longfeixiang Technology Products Manufacturing Co., Ltd., Sichuan (Jiangsu) Paul Technology Co., Ltd. Main drafters of this Standard: Li Lingshen, Li Guimei, Yang Wenfen, Lu Bing, Zhao Danqing, Hu Guangyong, Ding Bin, Zhao Jinyu, Liu Ji, Zheng Yuming, Zhang Yuanhu, Xing Keqi, Zhang Fuquan, Wang Xiangqin, Gong Guozhuo, Yue Weihua, Chen Shu, Li Jianquan, Chen Jinyu, Xie Jingwei, Gao Ming, Wang Jiajun, Zhang Xinyue, Chen Zhen, Luo Jun, Zhang Peng, Xu Hong, Wang Lu, Lu Yuzheng, Chen Longmin, Liu Sheng, Hao Runlin, Huang He, Yang Jian, Yin Xia. Page 3 of 23

4 Technical specification of daily protective mask 1 Scope This Standard specifies the terms and definitions, grading, technical requirements, test methods, inspection rules, packaging, marking, storage and transportation requirements of daily protective masks. This Standard applies to protective masks wore in the daily life to filter out particulate matters in the air pollution environment. This Standard does not apply to respiratory protection products used in hypoxic environments, underwater operations, escaping, fire protection, medical and industrial dust prevention and other special industries, nor for respiratory protection products for infants and children. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the dated edition cited applies. For undated references, the latest edition of the referenced document (including all amendments) applies. GB Respiratory protection - Non-powered air-purifying respirators GB/T 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 Specifications for damp heat testing chambers GB/T Specifications for low temperature test chambers GB/T Specifications for high temperature test chambers GB/T Textiles - Seam tensile properties of fabrics and made-up textile articles - Part 2: Determination of maximum force to seam rupture using the grab method GB/T Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods Page 4 of 23

5 GB Hygienic standard for disposable sanitary products GB/T Textiles - Determination of the banned azo colourants GB/T Textiles - Determination of 4-aminoazobenzene GB/T Textiles - Tests for colour fastness - Colour fastness to rubbing - Small areas 3 Terms and definitions For the purpose of this document, the following terms and definitions apply. 3.1 Particulate matter (PM 2.5 ) Particulate matters in the ambient air with aerodynamic equivalent diameter of less than or equal to 2.5 μm, also known as fine particulate matters. [GB , definition 3.4] 3.2 Filter efficiency Under the specified conditions, the ability of the mask body to filter out particulate matters, expressed as percentages. 3.3 Particle protective performance Under the specified conditions, the ability of the mask to block particulate matters, expressed as percentages. 4 Grading The particle protective performance of masks is divided from high to low into Grade A, Grade B, Grade C and Grade D; the ambient air quality to which each grade of masks is applicable is as shown in Table 1. All grades of masks shall be able to reduce the concentration of inhaled particulate matters (PM 2.5 ) to 75 μg/m 3 (the ambient air quality index category is good or above) in the corresponding air pollution environment. Page 5 of 23

6 6 Test methods 6.1 Visual inspection EXTRACT of 10 masks, INSPECT them using visual inspection method. The inspection light is subject to normal natural light; if fluorescent lighting is used, the illumination shall be not less than 400 lx. 6.2 Color fastness to rubbing TEST according to the specifications of GB/T For color fastness to dry rubbing, the outer layer of the mask is tested; for color fastness to wet rubbing, the layer of the mask contacting with human face is tested. 6.3 Formaldehyde content TEST according to the specifications of GB/T ph value TEST according to the specifications of GB/T The sample is cut from the layer of the mask contacting with human face. 6.5 Decomposable carcinogenic aromatic amine dyes TEST according to the specifications of GB/T and GB/T NOTE: In general, test according to GB/T first, when aniline and/or 1,4- phenylenediamine are detected, test according to GB/T Ethylene oxide residues According to the product identification, the mask treated with ethylene oxide is tested according to the specifications of Clause 9 in GB/T TAKE a parallel sample to test, and the sample is cut from the mask body. If one of the test results is qualified, and another test result is unqualified, the mean is not calculated; it shall resample to test, and the highest value is taken as the test result. The calculation result is expressed as relative content, accurate to one decimal place. 6.7 Inspiratory resistance Sample and pretreatment 4 samples, of which 2 are untreated samples and the other 2 are samples pretreated according to A.3.2 of Annex A. If the test sample has different models, each model shall have 2 samples, of which 1 is untreated sample and the other is a sample Page 8 of 23

7 6.7.4 Test methods CHECK the airtightness and working condition of the testing device. ADJUST the ventilation capacity to (85 ± 1) L/min and SET the system resistance of the testing device to 0. WEAR the test sample on the matching test head model, ADJUST the wear position and the tightness of the headband of the mask, to ensure that the mask is in close contact with the test head model. ADJUST the ventilation capacity to (85 ± 1) L/min, MEASURE and RECORD the inspiratory resistance. During the test, TAKE appropriate measures to avoid attaching the sample to the respiratory tube. 6.8 Expiratory resistance Sample and pretreatment The requirements are the same as those of Testing device The testing device of expiratory resistance is as shown in Figure The flowmeter is the same as that of The micro-pressure meter is the same as that of The dimension of the test head model is the same as that of The ventilation capacity of the air compressor shall be not less than 100 L/min Testing condition The requirements are the same as those of Test method CHECK the airtightness and working condition of the testing device. ADJUST the ventilation capacity to (85 ± 1) L/min and SET the system resistance of the testing device to 0. WEAR the test sample on the matching test head model, ADJUST the wear position and the tightness of the headband of the mask, to ensure that the mask is in close contact with the test head model. ADJUST the ventilation capacity to (85 ± 1) L/min, MEASURE and RECORD the expiratory resistance. During the test, TAKE appropriate measures to avoid attaching the sample to the respiratory tube. 6.9 Breaking strength of mask tie and the connection between mask tie and mask body Page 10 of 23

8 6.11 Microbiological indicators TEST according to the specifications of GB Vision TEST according to the specifications of 6.8 in GB Filter efficiency TEST according to the specifications of Annex A Particle protective performance TEST according to the specifications of Annex B. 7 Inspection rules 7.1 Sampling Products of the same batch and the same specification (model) in delivery batch number are regarded as a test batch. Randomly extract the corresponding quantity of samples from each test batch according to the test requirements. When the delivery number of a same delivery batch is greater than , the number of samples is doubled. 7.2 Determination of quality Determination of appearance quality The appearance quality is tested according to 6.1, at least 8 and more than 8 samples shall meet the requirements of 5.2. It is determined qualified if it meets the requirements of 5.2, otherwise it is determined unqualified Determination of intrinsic quality If the test results of intrinsic quality, filter efficiency and particle protective performance meet the requirements of 5.3, 5.4 and 5.5 respectively, it is determined qualified, otherwise it is determined unqualified Determination of results If the test results of appearance quality, intrinsic quality, filter efficiency and particle protection performance are all qualified, this batch of products is determined qualified, otherwise this batch of products is determined unqualified. Page 12 of 23

9 Annex A (normative) Test method for filter efficiency A.1 Scope This annex specifies the test method for the filter efficiency of masks. This annex applies to daily protective masks. A.2 Test principle GENERATE aerosol particles having a certain concentration and particle size distribution by the aerosol generator, and PASS them through the mask body at specific gas flow; USE appropriate particulate matter testing device to test the concentration of the particulate matter before and after passing through the mask body. The filter efficiency of the mask body on the particulate matter is evaluated by the percentage of particulate matter concentration decreases after the aerosol particles passing through the mask body. A.3 Sample and pretreatment A.3.1 TAKE 16 samples, DIVIDE into two groups; one group uses salt media to test, and one group uses oily media to test. 5 of each group are untreated samples and 3 are samples pretreated according to A.3.2. A.3.2 Temperature and humidity pretreatment A Pretreatment equipment A The technical performance of damp heat test chamber shall meet the requirements of GB/T A The technical performance of high temperature test chamber shall meet the requirements of GB/T A The technical performance of low temperature test chamber shall meet the requirements of GB/T A Pretreatment method TAKE the sample from the original package, TREAT them in the following order: a) PLACE in the environment of (38 ± 2.5) C and (85 ± 5) % relative humidity for Page 14 of 23

10 Annex B (normative) Test method for particle protective performance B.1 Scope This annex specifies the test method for the particle protective performance of daily protective masks. This annex applies to daily protective masks. Other masks can refer to this annex. B.2 Principle GENERATE aerosol particles having a certain concentration and particle size distribution by the aerosol generator, and PASS them through the mask body at specific gas flow; USE appropriate particulate matter testing device to test the concentration of the particulate matter before and after passing through the mask body. The filter efficiency of the mask body on the particulate matter is evaluated by the percentage of particulate matter concentration decreases after the aerosol particles passing through the mask body. B.3 Sample and pretreatment TAKE 16 samples, DIVIDE into two groups; one group uses salt media to test, and one group uses oily media to test. 5 of each group are untreated samples and 3 are samples pretreated according to the temperature and humidity specified in A.3.2. B.4 Test environment The temperature is (25 ± 5) C and the relative humidity is (30 ± 10) %. B.5 Test device for particle protective performance B.5.1 Schematic diagram of test device for particle protective performance The test device for particle protective performance is as shown in Figure B.1. Page 17 of 23

11 it reaches the concentration of the effective space in the test chamber in B.5.3, Open the respiratory simulator. B.6.4 USE the aerosol concentration monitoring device to record the concentration C 1 of the test media in the test chamber and the concentration C 2 of the test media in the gas inhaled through the head model s respiratory tube. B.6.5 STAND for 1 h; MONITOR the values of C 1 and C 2 during the entire test process; CALCULATE the particle protective performance of the sample. B.7 Calculation of particle protective performance The particle protective performance is calculated according to formula (B.1): where: P = (C 1 - C 2 + C 0 )/C 1 100%... (B.1) C 1 - the concentration of the test media in the test chamber during the test process, in milliliters per cubic meter (mg/m 3 ); C 2 - the concentration of the test media in the gas inhaled through the head model s respiratory tube during the test process, in milliliters per cubic meter (mg/m 3 ); C 0 - the background concentration of the particulate matters in the test mask, in milligrams per cubic meter (mg/m 3 ). During the test, MONITOR the values of C 1 and C 2 at the same time and CALCULATE the particle protective performance of the sample at each sampling time. The minimum value of the particle protective performance obtained during the entire test process is taken as the particle protective performance of the sample. Page 20 of 23