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GB 2626-2019 PDF in English


GB 2626-2019 (GB2626-2019) PDF English
Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
GB 2626-2019English265 Add to Cart 0-9 seconds. Auto-delivery. [N95/KN95 face mask] Respiratory protection -- Non-powered air-purifying particle respirator Valid
GB 2626-2006English115 Add to Cart 0-9 seconds. Auto-delivery. [Replaced by GB 2626-2019] Respiratory protective equipment -- Non-powered air-purifying particle respirator Obsolete
GB/T 2626-1992English359 Add to Cart 3 days General technical requirements for self-inhalation filtertype dust respirator Obsolete
Standards related to (historical): GB 2626-2019
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GB 2626-2019: PDF in English

GB 2626-2019 NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 13.340.30 C 73 Replacing GB 2626-2006 Respiratory protection - Non-powered air-purifying particle respirator ISSUED ON: DECEMBER 31, 2019 IMPLEMENTED ON: JULY 01, 2020 Issued by: State Administration for Market Regulation; Standardization Administration of PRC. Table of Contents Foreword ... 4  1 Scope ... 6  2 Normative references ... 6  3 Terms and definitions ... 7  4 Classification and marking ... 11  4.1 Classification of facepiece ... 11  4.2 Classification of filter element ... 11  4.3 Grades of filter element ... 12  4.4 Marking ... 12  5 Technical requirements ... 12  5.1 Basic requirements ... 12  5.2 Visual inspection ... 13  5.3 Filter efficiency ... 14  5.4 Leakage ... 14  5.5 Breathing resistance ... 15  5.6 Exhalation valve ... 15  5.7 Dead space ... 16  5.8 View field ... 16  5.9 Head harness ... 16  5.10 Connections and connecting parts ... 17  5.11 Lens ... 17  5.12 Air tightness ... 17  5.13 Flammability ... 17  5.14 Cleaning and disinfection ... 18  5.15 Practical performance ... 18  5.16 Information to be provided by the manufacturer ... 18  5.17 Packaging ... 20  6 Testing methods ... 20  6.1 Visual inspection ... 20  6.2 Pretreatment ... 20  6.3 Filter efficiency ... 22  6.4 Leakage ... 26  6.5 Inhalation resistance ... 31  6.6 Exhalation resistance ... 34  6.7 Air tightness of exhalation valve ... 34  6.8 Protection device of exhalation valve ... 36  6.9 Dead space ... 36  6.10 View field ... 38  6.11 Head harness ... 38  6.12 Connections and connecting parts ... 39  6.13 Lens ... 40  6.14 Air tightness ... 40  6.15 Flammability ... 41  6.16 Practical performance ... 42  7 Product marking ... 43  7.1 Markings on the product ... 43  7.2 Marking on the packaging ... 43  Appendix A (Informative) Summary of testing requirements ... 45  Appendix B (Informative) CMD and MMAD conversion method ... 48  Appendix C (Normative) Method for judging whether KP filter element’s loading filter efficiency continues to decrease ... 51  Appendix D (Normative) Main dimensions of test head mold ... 53  Appendix E (Informative) Main differences between this standard and the 2006 edition ... 54  References ... 57  Foreword This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB 2626-2006 "Respiratory protection equipment - Non-powered air-purifying particle respirator". Compared with GB 2626-2006, the main changes in this standard are as follows: - CHANGE the standard name from "Respiratory protection equipment - Non-powered air-purifying particle respirator" to "Respiratory protection - Non-powered air-purifying particle respirator"; - DELETE three terms "smoke", "fog" and "microorganism"; ADD seven terms "penetration", "user face-seal check", "assigned protection factor", "count median diameter", "mass median diameter", "aerodynamic diameter", "mass median aerodynamic diameter" (see 3.14 and 3.19 ~ 3.24); - MODIFY the requirements for inspiratory resistance and expiratory resistance of various types of respirators (see 5.5); - MODIFY the requirements and test methods for air tightness of exhalation valves (see 5.6.1 and 6.7); - MODIFY the name of the exhalation valve cover to an exhalation valve protection device (see 5.6.2 and 6.8); - MODIFY the vision requirements for various types of respirators (see 5.8); - ADD the requirements and test methods for products that the manufacturer claims filter elements can be reused after cleaning and / or disinfection [see 5.14.1, 5.16d), 6.2.3]; - ADD the practical performance requirements and testing methods (see 5.15 and 6.16); - ADD a description of the method of judging the service life of filter elements in the information part to be provided by the manufacturer; ADD the application restrictions on non-flame-retardant products (see 5.16); - In the testing method of filter efficiency, ADD the conversion method of particle size used for testing of filter efficiency (see Appendix B), requirements for accuracy and resolution of particle detector for the filter efficiency testing equipment (see 6.3.2) and judgment of loading end point (see 6.3.4.4, 6.3.4.5, 6.3.4.6, Appendix C); ADD the requirements for load (see 6.3.3); - In the testing method of leakage, ADD requirements for sample inspection (see 6.4.1.4); ADD the accuracy requirements for particle detectors (see 6.4.2.4); ADD a formula for calculating the inward leakage by subject [see formula (5)]; - ADD the schematic diagram of the structure of the built-in breathing hose for the test head mold for breathing resistance testing and dead space testing (see Figure 4); - In the test method of breathing resistance, MODIFY the requirements for the micromanometer parameters (see 6.5.2.3); ADD the requirements for airtightness between the respirator facepiece and the test head mold (see 6.5.4 and 6.6.4); - MODIFY the schematic diagram of the testing device for dead space (see Figure 6); - In the test method of head harness, ADD the requirement to apply the test tensile force in the direction in which the head harness is stretched during normal use (see 6.11.3). Note: See Appendix E for the main differences between this standard and the 2006 edition. This standard was proposed by and shall be under the jurisdiction of the Ministry of Emergency Management of the People's Republic of China. Drafting organizations of this standard: China Iron and Steel Group Wuhan Safety and Environmental Protection Research Institute Co., Ltd., Academy of Military Science and Chemical Research Institute, 3M China Co., Ltd. The main drafters of this standard: Cheng Jun, Ding Songtao, Yang Xiaobing, Yao Hong, Zhou Xiaoping, Cai Xialin, Zhang Shouxin, Yu Jingjing. This standard was first issued in 1981, revised to GB/T 2626-1992 in 1992, then revised to GB 2626-2006 in 2006. Respiratory protection - Non-powered air-purifying particle respirator 1 Scope This standard specifies the classification and marking, technical requirements, testing methods, identification of non-powered air-purifying particle respirator. This standard applies to non-powered air-purifying respirator that protects against particle. This standard does not apply to respirators that protect against harmful gases and vapors. It does not apply to the respirators for hypoxic environments, underwater operations, escape, fire-fighting. 2 Normative references The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard. GB 2890-2009 Respiratory protection - Non-powered air-purifying respirators GB/T 5703 Basic human body measurements for technological design GB/T 10586 Specifications for damp heat chambers GB/T 10589 Specifications for low temperature test chambers GB/T 11158 Specifications for high temperature test chambers GB/T 18664-2002 Selection, use and maintenance of respiratory protective equipment GB/T 23465-2009 Respiratory protective equipment - Practical performance evaluation methods 3 Terms and definitions The following terms and definitions apply to this document. 3.1 Particle Solid, liquid or particle mixed with solid and liquid suspended in air, such as dust, smoke, mist and microorganisms. [GB/T 18664-2002, definition 3.1.15] 3.2 Dust The tiny solid particles suspended in the air, which are generally produced by the solid materials being broken by mechanical forces. [GB/T 18664-2002, definition 3.1.16] 3.3 Non-powered air-purifying respirator Filtered respirator that relies on the wearer’s breathing to overcome the airflow resistance of the component. [GB/T 18664-2002, definition 3.1.3] 3.4 Tight-fitting facepiece A facepiece that can cover the mouth and nose and fit tightly to the face, or a facepiece that can cover the eyes, mouth, and nose and fit tightly to the head and face. Note 1: The close-fitting facepiece is divided into a half facepiece and a full facepiece. Note 2: Rewrite GB/T 18664-2002, definition 3.1.5. 3.5 Half facepiece A tight-fitting facepiece that covers the mouth and nose, or covers the mouth, nose, and jaw. Note: Half facepieces are divided into disposable facepieces and replaceable half facepieces. 3.6 Full facepiece Tight-fitting facepiece that covers eyes, mouth, nose and jaw. 3.7 Disposable facepiece A half facepiece mainly composed of a filter material, which can be provided with an exhalation valve. 3.8 Replaceable facepiece Closed half-facepieces and full facepieces with single or multiple replaceable filter elements, which can be provided with breathing valves and / or breathing hose. 3.9 Inhalation valve A one-way valve that only allows inhaled air to enter the facepiece and prevents exhaled air from exiting the facepiece through it. [GB 2890-2009, definition 3.6] 3.10 Exhalation valve A one-way valve that only allows exhaled air to exit the facepiece and prevents inhaled air from entering the facepiece through it. [GB 2890-2009, definition 3.7] 3.11 Breathing hose A flexible, air-tight air hose for connecting a facepiece to a filter element. 3.12 Filter element Filter materials or filter components used in filtered respirators to filter out harmful substances in the inhaled air. Examples: canisters (filter cartridges), dust canisters, filter media, etc. [GB/T 18664-2002, definition 3.1.22] 3.13 Filter efficiency Under the specified testing conditions, the level of particle is filtered out by the filter element. 3.14 Penetration The level of particle penetrating the filter element under specified testing conditions. Note: Penetration = 100% - filter efficiency. 3.15 Total inward leakage; TIL Under the specified laboratory test environment, the ratio of the concentration of the simulant leaked into the facepiece from all the facepiece components including the filter element when the subject inhaled to the concentration of the simulant in the test environment outside the respirator facepiece. Total inward leakage = Ci / C0 × 100% ………………………… (1) Where: Ci - The concentration of the simulant in the respirator facepiece; C0 - Concentration of the simulant in the test environment outside the respirator facepiece. 3.16 Inward leakage; IL Under the specified laboratory testing environment, the ratio of the concentration of the simulant leaked into the facepiece from all other parts of the facepiece except the filter element when the subject inhaled to the concentration of the simulant in the test environment outside the respirator facepiece. Inward leakage = Ci/C0 × 100% ………………………… (2) Where: Ci - The concentration of the simulant in the respirator facepiece; C0 - Concentration of the simulant in the test environment outside the respirator facepiece. 3.17 Dead space Volume fraction of carbon dioxide gas as re-inhaled from a previous exhalation. 3.18 Head harness A part for fixing the facepiece on the head. 3.19 User face-seal check A simple tightness check method performed by the respirator wearer, to ensure that the tight-fitting facepiece is worn correctly. Note: Rewrite GB/T 18664-2002, definition 3.1.24. 3.20 Assigned protection factor One type or category of respiratory protective equipment with suitable functions, which is expected to reduce the concentration of air pollutants on the premise that it is suitable for users to wear and use correctly. Note: Rewrite GB/T 18664-2002, definition 3.1.29. 3.21 Count median diameter; CMD When the particles are sorted according to the particle size, the particle size at which the number of particles larger than the particle size and smaller than the particle size each accounts for 50% of the total particle size. 3.22 Mass median diameter; MMD When the particles are sorted according to the particle size, the particle size at which the mass of particles larger than the particle size and smaller than the particle size each accounts for 50% of the total particle mass. 3.23 Aerodynamic diameter The diameter of a unit density spherical particle that has the same settling velocity as the particle in question. 3.24 Mass median aerodynamic diameter, MMAD When the particle is sorted according to the size of the aerodynamic particle size, the particle size at which the mass of particles larger than the particle size and smaller than the particle size each accounts for 50% of the total particle mass. 4 Classification and marking 4.1 Classification of facepiece According to the structure, the facepiece is divided into three types: disposable facepiece, replaceable half facepiece, full facepiece. 4.2 Classification of filter element Filter elements are divided into two categories: KN and KP. Category KN is only suitable for filtering non-oily particles; category KP is suitable for filtering oily and non-oily particles. 4.3 Grades of filter element According to the level of filter efficiency, the grades of filter elements is classified according to Table 1. Table 1 -- Grades of filter element Type of filter element Type of facepiece Disposable facepiece Replaceable half facepiece Full facepiece Category KN KN90 KN95 KN100 KN90 KN95 KN100 KN95 KN100 Category KP KP90 KP95 KP100 KP90 KP95 KP100 KP95 KP100 4.4 Marking The filter elements of disposable facepieces and replaceable facepieces shall be marked with grades; the grades shall be marked with a combination of the number of this standard and the type and grade of filter elements. Example 1: The KN90 filter element is marked as GB 2626-2019 KN90. Example 2: The KP100 filter element is marked as GB 2626-2019 KP100. 5 Technical requirements 5.1 Basic requirements Check in accordance with 6.1 and evaluate in 6.16. The material and structural design of the respirator shall meet the following requirements: a) The material shall meet the following requirements: 1) Materials that are in direct contact with the face shall be harmless to the skin; 2) The filter material shall be harmless to the human body; 3) The material used shall have sufficient strength; in normal use, it shall not be damaged and deformed that affects the use effect; 4) No obvious tenderness or tingling sensation when wearing it. b) The structural design shall meet the following requirements: 1) It shall not be easy to cause structural damage; the design, composition, installation of components shall not pose any danger to the user; 2) The design of the head harness shall be elastic material or adjustable, for easy wearing and removal. It shall be able to firmly fit the facepiece on the face; there shall be no obvious compression or tenderness when wearing. The head harness of replaceable half facepiece and full facepiece shall be designed to be replaceable; 3) If the facepieces of the same size and the same style have different wearing methods, they shall be tested as different products; Note 1: Different wearing methods of the same style facepiece will affect the tightness of the facepiece. 4) It shall not significantly affect the visual field; 5) When wearing, the lenses of the full facepiece shall not affect the vision, such as fogging; 6) Respirators which use replaceable filter elements, inhalation valves, exhalation valves, head harness shall be designed for easy replacement; meanwhile it allows the wearer to check the airtightness of the facepiece and face at any time and conveniently, to make user face-seal check; Note 2: See Appendix G of GB/T 18664-2002 for user face-seal check method. 7) The breathing hose shall not restrict the movement of the head or the wearer; it shall not affect the tightness of the facepiece; it shall not restrict or block the airflow; 8) The front side of the exhalation valve shall be protected. The exhalation valve protection device can be a dedicated component, or it can be protected by other components on the facepiece; 9) The structure of the disposable facepiece shall ensure close fit with the face; meanwhile it shall not deform during normal use; 10) The parts of the replaceable facepiece (except the filter element) shall be washable. 5.2 Visual inspection Check it in accordance with 6.1. The surface of the sample shall neither be damaged, deformed, nor have other obvious defects. The material and structure of the component shall be able to withstand normal use conditions and the temperature, humidity and mechanical shock that may be encountered. After the temperature and humidity pretreatment and mechanical strength pretreatment according to the method of 6.2, the components shall not fall off, be damaged or deformed. The inspection shall also include markings and various information as provided by the manufacturer. 5.3 Filter efficiency Use sodium chloride (NaCl) particles to test the KN filter elements. Use dioctyl phthalate (DOP) or oil particles (such as paraffin oil) of equivalent nature to test the KP filter elements. Perform testing in accordance with the method of 6.3. In the testing process, the filter efficiency of each sample shall always meet the requirements of Table 2. Table 2 -- Filter efficiency 5.4 Leakage 5.4.1 TIL for disposable facepieces Perform test in accordance with the method of 6.4. The TIL of disposable facepieces shall meet the requirements of Table 3. Table 3 -- TIL of disposable facepieces Grade of filter material When using the TIL of each action (i.e. 10 people x 5 actions) as the basis for evaluation, the TIL of at least 46 of the 50 actions When using the overall TIL as the basis for evaluation, the overall TIL of at least 8 persons of the 10 persons under test KN90 or KP90 < 13% < 10% KN95 or KP95 < 11% < 8% KN100 or KP100 < 5% < 2% Not applicable Not applicable Category and grade of filter element Tested by sodium chloride particle Tested by oily particle 5.4.2 IL of replaceable half facepiece Perform test in accordance with the method of 6.4. When using the IL of each action (i.e. 10 people x 5 actions) as the basis for evaluation, the IL of at least 46 of the 50 shall be less than 5%. When using the overall IL of person as the basis for evaluation, the overall IL of at least 8 persons of the 10 persons under test shall be less than 2%. 5.4.3 IL of full facepiece Perform test in accordance with the method of 6.4. When the IL of each action is used as the basis for evaluation (i.e. 10 persons x 5 actions), the IL of each action shall be less than 0.05%. 5.5 Breathing resistance Perform test in accordance with the method of 6.5 and 6.6. The inhalation resistance and exhalation resistance of all types of respirators shall meet the requirements of Table 4. Table 4 -- Requirements for breathing resistance Type of facepiece Inhalation resistance / Pa Exhalation resistance / Pa KN90 and KP90 KN95 and KP95 KN100 and KP100 Disposable facepiece, without exhalation valve ≤ 170 ≤ 210 ≤ 250 Same as inhalation resistance Disposable facepiece, with exhalation valve ≤ 210 ≤ 250 ≤ 300 ≤ 150 Replaceable half facepiece and full facepiece including filter element ≤ 250 ≤ 300 ≤ 350 5.6 Exhalation valve 5.6.1 Air tightness of exhalation valve Detects only half facepieces. The exhalation valve shall meet the following requirements: When tested according to the method of 6.7, the leakage flow rate of the exhalation valve of each respirator shall not be greater than 30 mL/min; if the facepiece is provided with multiple exhalation valves, the leakage airflow that each exhalation valve shall meet shall be shared equally, for example, if the respirator facepiece is provided with 2 exhalation valves, the leakage air flow of each exhalation valve shall not be greater than 15 mL/min. 5.6.2 Protection device of exhalation valve Perform test in accordance with the method of 6.8. The exhalation valve’s protection device shall not slip, break and deform when it is subjected to the axial tensile force as specified in Table 5. Table 5 -- Axial tensile force that the exhalation valve’s protection device shall withstand Type of facepiece Disposable facepiece Replaceable facepiece Tensile force 10 N for 10 s 50 N for 10 s 5.7 Dead space Perform test in accordance with the method of 6.9. The average dead space result of the respirator shall not be greater than 1%. 5.8 View field Perform test in accordance with the method of 6.10. The view field of the respirator shall meet the requirements of Table 6. Table 6 -- View field View field Type of facepiece Half facepiece Full facepiece Big view window Double view window Below view field ≥ 35° ≥ 35° ≥ 35° Overall view field Not applicable ≥ 70% ≥ 65% Double-eye view field ≥ 65% ≥ 55% ≥ 24% 5.9 Head harness Perform test in accordance with the method of 6.11. Each head harness, buckle and other adjustment parts of the respirator shall not slip or break when it is subjected to the tensile force as specified in Table 7. Table 7 -- Tensile force that the head harness shall withstand Type of facepiece Disposable facepiece Replaceable half facepiece Full facepiece Tensile force 10 N for 10 s 50 N for 10 s 150 N for 10 s 5.10 Connections and connecting parts Perform test in accordance with the method of 6.12. Under the specified test conditions, all connections and connection parts between the replaceable filter element and the facepiece, and between the breathing hose and the filter element and the facepiece, shall not slip, break or deform when subjected to the axial tensile force as specified in Table 8. Table 8 -- Axial tensile forces that the connection and connecting parts shall withstand Type of facepiece Replaceable half facepiece Full facepiece Tensile force 50 N for 10 s 250 N for 10 s 5.11 Lens 5.11.1 Only full facepieces are tested. 5.11.2 Perform test in accordance with the method of 6.13. The lens of each sample shall not be broken or cracked. Then test the airtightness in accordance with the method of 6.14, which shall meet the requirements of 5.12. 5.11.3 Perform test in accordance with the method of 6.16. The lens shall not cause distortion of the visual object. 5.11.4 If a product is added with ant-dimming paste, or an anti-fogging agent is designed to be used, the anti-fogging agent shall not use known harmful substances; after using the ant-dimming paste and / or anti-fogging agent, it shall not cause vision deformation or blurring; anti-fog agents shall not cause irritation and other discomfort to humans. They are tested in accordance with methods 6.1 and 6.16. 5.12 Air tightness Perform test in accordance with the method of 6.14. Under the specified testing conditions, the pressure change in each full facepiece within 60 s shall not be greater than 100 Pa. 5.13 Flammability 5.13.1 If the product design is non-flammable, it shall provide the information in accordance with the requirements of 5.16c) 1). 5.13.2 If the product is designed to be flame-retardant, it shall be tested in accordance with the method of 6.15. After the parts exposed to the flame are removed from the flame, the continuous burning time shall not exceed 5 s. 5.14 Cleaning and disinfection 5.14.1 If the product design allows the filter element to be reused after cleaning and / or disinfection, it shall meet the requirements of 5.16d); meanwhile the filter element shall be able to withstand the cleaning or disinfection treatment as recommended by the manufacturer. The cleaned or disinfected sample shall meet the requirements of 5.3 for filter efficiency, 5.4 for leakage, 5.5 for inhalation resistance. The manufacturer shall provide the user with the correct and effective method for determining whether the filter element will continue to be effective after cleaning or disinfection. 5.14.2 For replaceable facepieces, the facepieces shall be able to withstand the cleaning or disinfection treatment as recommended by the manufacturer; the samples after cleaning or disinfection shall meet the requirements of 5.4. 5.15 Practical performance Perform test in accordance with the method of 6.16. Under the conditions of simulated use, the performance which is hard to be evaluated by the use of other testing methods, such as the performance specified in 5.1b) and 5.11, the subject will provide subjective evaluation. If the respirator fails the test, the laboratory shall describe the test method in detail, so that other laboratories can repeat the test process. 5.16 Information to be provided by the manufacturer Perform inspection in accordance with the method of 6.1. The correctness of the information provided by the manufacturer shall be judged in accordance with the relevant provisions of GB/T 18664-2002. The information provided by the manufacturer shall meet the following requirements: a) It shall be provided with the smallest sales package. b) There shall be instructions in Chinese. c) It shall include the following information that the user must know: 1) Application scope and restrictions, which shall include (but not limited to) the applicable particle category (such as whether it contains oil), the assigned protection factor of the respirator, and / or other unsuitable application environments; if the product design is not flame-retardant, there shall be text description that "this product is not suitable for working places with open flames (such as welding, casting, etc.)"; 2) For replaceable filter elements, explain how to use them with full facepieces or half facepieces. If multiple filter materials are used, they shall be indicated; 3) Assembly method of replaceable facepiece; 4) Inspection method before use; 5) How to wear and how to do air tightness check; 6) How to judge the service life of disposable facepieces; 7) For replaceable facepieces, provide advice on when to replace the facepiece or filter element; 8) If applicable, maintenance methods (e.g. cleaning and disinfection methods); 9) Storage method; 10) Meaning of any symbols and icons used. d) If the product claims that the filter elements can be reused after cleaning and / or disinfection, it shall provide the following information: 1) The specific characteristics and / or scope of the applicable particle; 2) The maximum number of times it can be cleaned and / or disinfected; 3) Method to determine whether the filter element will continue to be effective and when to replace it after cleaning and disinfection. e) Provide warnings about problems that may be encountered during use, such as: 1) Fitness to the face of the wearer; 2) The hair under the seal...... ......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.