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GB 19083-2023 English PDF (GB 19083-2010, GB 19083-2003)

GB 19083-2023_English: PDF (GB19083-2023)
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GB 19083-2023English320 Add to Cart 0--9 seconds. Auto-delivery Protective face mask for medical use Valid GB 19083-2023
GB 19083-2010English70 Add to Cart 0--9 seconds. Auto-delivery Technical requirements for protective face mask for medical use Valid GB 19083-2010
GB 19083-2003English279 Add to Cart 3 days [Need to translate] Technical requirements for protective face mask for medical use Obsolete GB 19083-2003


BASIC DATA
Standard ID GB 19083-2023 (GB19083-2023)
Description (Translated English) Protective face mask for medical use
Sector / Industry National Standard
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 18,123
Date of Issue 2023-11-27
Date of Implementation 2025-12-01
Older Standard (superseded by this standard) GB 19083-2010
Administrative Organization State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Administration for Market Regulation, National Standardization Administration

BASIC DATA
Standard ID GB 19083-2010 (GB19083-2010)
Description (Translated English) Technical requirements for protective face mask for medical use
Sector / Industry National Standard
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,151
Date of Issue 2010-09-02
Date of Implementation 2011-08-01
Older Standard (superseded by this standard) GB 19083-2003
Quoted Standard GB/T 191; GB/T 2428-1998; GB/T 4745-1997; GB/T 5549-1990; GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15979-2002; GB/T 16886.10-2005; GB/T 18664-2002; YY/T 0691-2008; YY/T 0700-2008
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Medical clinical testing laboratories and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) Announcement of Newly Approved National Standards No. 4 of 2010 (total 159)
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This Chinese standard specifies the medical protective masks (hereinafter referred to as masks) the technical requirements, test methods, marking and instructions for use and the packaging, transportation and storage. This standard applies to medical work environment, filter the air of particulate matter, barrier spray, blood, body fluids, secretions and other self-absorption filter respirator.

BASIC DATA
Standard ID GB 19083-2003 (GB19083-2003)
Description (Translated English) Technical requirements for protective face mask for medical use
Sector / Industry National Standard
Classification of Chinese Standard C73
Word Count Estimation 7,722
Date of Issue 2003/4/29
Date of Implementation 2003/4/29
Regulation (derived from) Announcement of Newly Approved National Standards 2010 No. 4 (No. 159 overall)
Summary This Standard specifies respirator (hereinafter referred to as masks) of the basic requirements, test methods, labeling and instruction manual and packaging, transport and storage; This Standard is applicable to particles in the air can be filtered, barrier spray, blood, body fluids, secretions and other self-absorption filter respirator;


GB 19083-2023 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 CCS C 44 Replacing GB 19083-2010 Protective face mask for medical use ISSUED ON: NOVEMBER 27, 2023 IMPLEMENTED ON: DECEMBER 01, 2025 Issued by: State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of Contents Foreword ... 4 1 Scope ... 5 2 Normative references ... 5 3 Terms and definitions ... 6 4 Requirements ... 7 4.1 Basic requirements ... 7 4.2 Mask belt connection strength ... 7 4.3 Filtration efficiency ... 7 4.4 Respiratory resistance ... 7 4.5 Dead space ... 8 4.6 Total inward leakage ... 8 4.7 Resistance against penetration by synthetic blood ... 8 4.8 Microbiological indicators ... 8 4.9 Ethylene oxide residue (if applicable) ... 8 4.10 Flammability (if applicable) ... 8 4.11 Biocompatibility... 8 5 Test methods ... 9 5.1 Test conditions ... 9 5.2 Basic requirements ... 9 5.3 Temperature and humidity pretreatment conditions ... 9 5.4 Mask belt connection strength ... 9 5.5 Filtration efficiency ... 10 5.6 Respiratory resistance ... 11 5.7 Dead space ... 13 5.8 Total inward leakage ... 14 5.9 Resistance against penetration by synthetic blood ... 15 5.10 Microbiological indicators ... 15 5.11 Residue of ethylene oxide ... 15 5.12 Flammability ... 15 5.13 Biocompatibility ... 16 6 Marking and instruction for use ... 16 6.1 Marking ... 16 6.2 Instructions for use ... 17 7 Packaging and storage ... 17 7.1 Packaging ... 17 7.2 Storage ... 17 Appendix A (Informative) Fit test method before mask selection ... 18 Bibliography ... 23 Protective face mask for medical use 1 Scope This document specifies the requirements, markings, instructions for use, as well as packaging and storage of disposable protective face mask for medical use (hereinafter referred to as “face mask”), and describes the corresponding test methods. This document is applicable to non-powered air-purifying face masks (half masks) for filtering particles in the air and blocking droplets, blood, body fluids, secretions, etc. in medical working environments. This document does not apply to masks that protect against any chemical gases and vapors. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document. GB 2626-2019, Respiratory protection - Non-powered air-purifying particle respirator GB/T 14233.1-2022, Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T 16886.5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity GB/T 16886.10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization GB/T 16886.12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials GB/T 32610-2016, Technical specification of daily protective mask YY 0469, Surgical mask YY/T 0691-2008, Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) YY/T 0866, Total inward leakage determination method of protective face mask for medical use Pharmacopoeia of the People’s Republic of China 2020 Edition Volume IV ISO 16900-5:2016/Amd.1:2018, Respiratory protective devices - Methods of test and test equipment - Part 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools/Amendment 1: RPD head forms front and side view 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 filtering efficiency The percentage of particulate matter filtered out by the mask under specified test conditions. 3.2 dead space The volume of air that is re-inhaled from the previous exhalation. Note: It is expressed by the volume fraction of CO2 in the inhaled gas. [Source: GB/T 12903-2008, 5.3.10] 3.3 total inward leakage; TIL The ratio of the concentration of the simulated agent leaking into the mask from all parts including the mask when the subject inhales TO the concentration of the simulated agent in the test environment under the test conditions specified in the laboratory. [Source: GB/T 12903-2008, 5.3.7, modified] 3.4 fit The degree of fit between the periphery of the mask and the specific user’s face. 4.5 Dead space The average volume fraction of CO2 in inhaled air shall not exceed 1%. 4.6 Total inward leakage The total inward leakage shall meet the requirements in Table 1. 4.7 Resistance against penetration by synthetic blood Spray 2 mL of synthetic blood onto the mask at a pressure of 16 kPa (120 mmHg), and there shall be no penetration on the inside of the mask. 4.8 Microbiological indicators 4.8.1 Sterile masks shall be sterile. 4.8.2 The total number of microorganisms in non-sterile masks shall be less than or equal to 100 CFU/g. 4.9 Ethylene oxide residue (if applicable) If the mask has been ethylene oxide-sterilized or disinfected, its ethylene oxide residue shall not exceed 10 μg/g. 4.10 Flammability (if applicable) If the manufacturer expressly states that the mask material is not flammable, when testing according to 5.12, the after-flame time shall not exceed 5 seconds. 4.11 Biocompatibility 4.11.1 Skin irritation The primary stimulation score shall not be greater than 0.4. 4.11.2 Cytotoxicity The relative cell proliferation rate (survival rate) shall not be less than 70%. 4.11.3 Delayed type hypersensitivity Delayed type hypersensitivity shall not be greater than grade 1. 5 Test methods 5.1 Test conditions Except for special requirements, the test shall be carried out in an environment with a temperature of 16 °C ~ 32 °C and a relative humidity of (50±30)%. 5.2 Basic requirements Randomly select at least 3 masks from 3 minimum independent packaging units, visually inspect and actually wear them, and check whether they meet the requirements of 4.1. 5.3 Temperature and humidity pretreatment conditions Remove the sample packaging and perform pretreatment in the following order: a) Place in an environment of (38±2.5) ℃ and (85±5)% relative humidity for (24±1) h; b) Place in a dry environment of (70±3) °C for (24±1) h; c) Place in an environment of (-30±3) °C for (24±1) h. The pretreatment method used should avoid thermal shock, and allow the sample temperature to return to room temperature for at least 4 hours before subsequent pretreatment or testing. 5.4 Mask belt connection strength 5.4.1 Number of samples Take at least 4 mask samples and perform temperature and humidity pretreatment according to 5.3. 5.4.2 Testing methods Fix the main body of the mask with the outer side of the mask facing up; cut the mask belt from the middle; let the mask belt hang naturally; apply a static pull force of 10 N at the end for 10 seconds. The mask belt and the connection must not be disconnected. In case of disconnection, the disconnection part (mask belt or connection point) shall be reported. If there is no fixed connection between the mask belt and the mask body, the mask belt shall be removed, with one end fixed, and the other end loaded with a static tension force of 10 N for 10 seconds. The mask belt shall not be disconnected. Keys: 1 – aerosol generator; 2 – compressed air source; 3 – flow control module; 4 – gas release (when the test flow rate is lower than the spray flow rate); 5 – air supply (when the test flow rate is higher than the spray flow rate); 6 – testing cabin; 7 – mask; 8 – two-way valve; 9 – aerosol photometer 1; 10 – aerosol photometer 1; 11 – flow meter; 12 – vacuum pump. Figure 1 – Schematic diagram of filtering efficiency testing device 5.5.3 Testing methods When the detection flow rate is (85±4) L/min, carry out the loading test, and the total loading amount shall be at least (50±5) mg. Before starting the test, fix and seal the edge of the mask to keep the shape of the mask consistent with the normal wearing mode; if necessary, use a special clamp. After the test starts, record the filtering efficiency during the loading process. When the specified loading capacity is not reached and the filtering efficiency is lower than the grade limit required in 4.3, the test shall be stopped and the sample shall be judged to be unqualified. When the specified loading capacity is reached and the filtering efficiency has not been lower than the required limit of this grade, judge it to be qualified. Record the lowest value during the test as the filtering efficiency of the mask. 5.6 Respiratory resistance 5.6.1 Number of samples Take at least 4 mask samples and perform temperature and humidity pretreatment according to 5.3. 5.6.2 Testing equipment and testing conditions 5.6.2.1 Test head form The head form specified in Appendix D of GB 2626-2019, Appendix B of GB/T 32610- 2016 or ISO 16900-5:2016/Amd.1:2018 can be used. 5.6.2.2 Testing equipment and conditions 5.9 Resistance against penetration by synthetic blood Take at least 4 masks and carry out the test according to the method specified in YY/T 0691-2008. If all the results meet the requirements of 4.7, judge it as qualified. For the preparation method of synthetic blood, see YY 0469. 5.10 Microbiological indicators 5.10.1 Sterility Carry out the test in accordance with the test methods for sterility inspection method (General Chapter 1101) of the Pharmacopoeia of the People's Republic of China (2020 Edition, Volume IV). Carry out the treatment of the test sample and the inoculation culture medium in accordance with the provisions of the dressing test sample in the direct inoculation method. 5.10.2 Microbial limits Carry out the test in accordance with the membrane-filter procedure stipulated in the microbial enumeration method (General Chapter 1105) in the microbial limit inspection of non-sterile products in Pharmacopoeia of the People's Republic of China (2020 edition, volume IV). Obtain the total number of microorganisms by adding the results of the total number of aerobic bacteria, mold and yeast. Preparation of test solution: Randomly select at least 2 smallest packages; take no less than 10 g of the test sample; cut it into pieces and use a diluent containing 0.1% (volume fraction) polysorbate 80 (or other non-bacterial surfactant) – such as pH 7.0 sterile sodium chloride-peptone buffer, or pH 7.2 phosphate buffer, or 0.9% sterile sodium chloride solution – to prepare a 1:50 (g/mL) test solution; mix thoroughly. 5.11 Residue of ethylene oxide Carry out the test according to the method specified in 9.4 of GB/T 14233.1-2022. 5.12 Flammability 5.12.1 Number of samples Take at least 4 mask samples and perform temperature and humidity pretreatment according to 5.3. 5.12.2 Testing methods Follow the following steps for testing. When all samples meet the requirements of 4.10, judge them to be qualified. a) Wear the mask on the metal head form, and set the distance between the top of the burner and the lowest part of the mask (when placed directly facing the burner) at (20±2) mm. b) Adjust the flame height to (40±4) mm. Use a metal-isolated thermocouple probe to measure the temperature of the flame at (20±2) mm above the top of the burner, which shall be (800±5) °C. c) Pass the head form through the flame at a linear speed of (60±5) mm/s, and record the combustion state of the mask after passing through the flame once. 5.13 Biocompatibility 5.13.1 Sample preparation Mix the mask belt and the mask body materials according to the area ratio of 1:3 as a test sample. Prepare the leach solution of the test sample in accordance with the requirements of GB/T 16886.12. 5.13.2 Skin irritation Carry out the test according to the primary skin irritation method specified in GB/T 16886.10. 5.13.3 Cytotoxicity After using complete cell culture medium to dilute the test sample leach solution twice, carry out the cytotoxicity test according to the MTT method in GB/T 16886.5. The relative cell proliferation rate shall not be less than 70%. 5.13.4 Delayed type hypersensitivity Use the maximum dose for delayed type hypersensitivity in guinea pigs specified in GB/T 16886.10 for the test. 6 Marking and instruction for use 6.1 Marking The minimum sales unit of masks shall be provided with a clear Chinese marking, which shall at least include: a) Product name and grade specified in this document; b) Model and specifications; c) Production date and/or batch number; Appendix A (Informative) Fit test method before mask selection A.1 Necessity The fit of protective face mask for medical use is directly related to the protective effect of the wearer during actual use. Due to differences in individual face shapes, efforts in the design of protective mask products can only improve its fit among different individuals, that is, it can achieve better facial fit in a larger proportion of the population, but it cannot fit all wearers. For protective face masks for medical use of a certain model and size, users need to conduct a fit test before selecting them to reduce the risk of leakage from the fitting part. A.2 Evaluation cycle Changes in physical condition may change the fit of a user wearing a protective mask of the same brand, model, and size. Influencing factors may include significant changes in weight, changes in facial fitting parts (such as scars, dental corrections, etc.), and reduction in wearing comfort. Relevant agencies can organize a fit test for protective face masks for medical use once a year, which can also be determined based on the actual situation or other regulations, and can be carried out at any time when necessary. A.3 Precautions for mask wearers Mask wearers need to know the product size information and wearing method in advance, check whether the appearance is damaged, etc. and, after wearing, perform air tightness inspection according to the method specified by the manufacturer. Placing a mirror in the test area can better assist the wearer in checking. The wearer shall choose a mask that makes him/her feel comfortable subjectively when wearing it. Any discomfort, such as the sense of oppression caused by a tight mask belt, may only gradually appear after the wearer wears it for a period of time. Therefore, before the fit test, the wearer shall subjectively feel the mask for at least 5 minutes after correctly wearing it, and the feeling time can be extended if necessary. During the feeling period, the particles remaining in the breathing area during the wearing process can also be self-purified through the breathing process to prevent any impact on the fit test results. If there is beard hair at the fitting part between the mask and the face, it will also affect the fit test results to varying degrees. Therefore, before the fit test, the wearer needs to shave off the skin of the fitting part, which shall be carried out within 24 hours from the fit test. If conditions permit, it shall be carried out within 12 hours. A.5.2 Qualitative fit test A.5.2.1 Principle This method is a fit test method based on the wearer’s subjective feeling of the simulating agent. At present, simulating agents are usually sweetening agents or bittering agents. Qualitatively determine the inward leakage of the protective mask through the wearer’s perception of taste. When testing, only one reagent shall be selected, and bittering agents are used more often than sweetening agents. The sweetening agent is generally sodium saccharin solution, and the bittering agent is generally denatonium benzoate solution (Bitrex). A.5.2.2 Brief introduction to the method After putting on the mask, the wearer puts the head into a special test hood, and another person sprays sweetening agent or bittering agent aerosol particles into the test hood. If the wearer does not taste sweetness or bitterness when completing each action, the fit test is passed; if the wearer tastes sweetness or bitterness, the test fails, and shall wear the mask again or replace the mask before testing again. The specific test method can be carried out in accordance with the operating procedures of the commercial testing device. This method relies on the wearer’s taste sense to subjectively feel leakage. Therefore, at least 15 minutes before the test, any behavior that may interferes with taste, such as eating, drinking, chewing gum, smoking, etc., needs to be eliminated. Before the test, the wearer must first be screened for taste threshold to prove that he or she can detect aerosol particles of lower concentrations through taste. Wearers who cannot pass the taste threshold screening cannot be tested for fit by the qualitative method based on sweetening agents or bittering agents. After the wearer tastes sweetness or bitterness during taste threshold screening or subsequent testing, it usually takes a period of time to remove the residual taste from the lips and tongue; alternatively, it can be eliminated by rinsing and gargling. A.5.3 Quantitative fit test A.5.3.1 Brief introduction Quantitative fit test is a fit test method that quantifies the concentration of simulating agents inside and outside the mask through a specific testing device, where ambient aerosol condensation nuclei-counting (CNC) is a widely used quantitative method. A.5.3.2 Principle of CNC method This method uses particles in the environment as background values. When the wearer puts on the mask and completes prescribed actions, respectively detect the number of aerosol particles in the environment and inside the mask. By calculating the ratio of the ......


GB 19083-2010 ICS 11.100 C 44 NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Replacing GB 19083-2003 Technical Requirements for Protective Face Mask for Medical Use ISSUED ON: SEPTEMBER 2, 2010 IMPLEMENTED ON: AUGUST 1, 2011 Jointly issued by: The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ); Standardization Administration Committee (SAC) of The People’s Republic of China. Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative References ... 4  3 Terms and Definitions ... 6  4 Technical Requirements ... 6  5 Test Methods ... 8  6 Markings and Instructions for Use ... 11  7 Packaging And Storage ... 13  Appendix A (Informative) Preparation of Synthetic Blood ... 14  Appendix B (Normative) Fitness Test Method ... 16  References and Original Chinese Documents ... 19  Foreword In this Standard, Section 4.10 is recommendatory and other Sections are mandatory. This Standard replaces GB 19083-2003 "Technical Requirements for Protective Face Mask for Medical Use". Compared with GB 19083-2003, this Standard has the major changes detailed as follows: ——The applicable “Scope” of the standard was revised; ——The "Normative References” was supplemented and revised; ——The terms and definitions were added and changed; ——The dimensional requirement of mask was deleted; ——The length requirement of nasal splint was deleted; ——The "Fit" requirement and test method were added; ——The technical requirement of "Skin irritation" was revised according to GB/T 16886.10-2005 and the test method was defined; ——The technical requirement of markings and instructions for use was deleted; ——The original test method for oxirane residue specified in GB 15980-1995 was replaced by the gas chromatography method of GB/T 14233.1-2008; ——The test method of microorganism indexes was revised. In this Standard, Appendix B is normative and Appendix A is informative. This Standard was proposed by State Food and Drug Administration. This Standard is under the jurisdiction of the National Technical Committee on Clinical Laboratory Testing and Invitro Diagnostic Test Systems of Standardization Administration of China. Drafting organization of this Standard: Beijing Institute of Medical Device Testing Chief drafting staffs of this Standard: Su Jian, Bi Chunlei, Liao Xiaoman and Zhang Zhaoyuan. The previous standard replaced by this standard is: ——GB 19083-2003. NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Replace 19083-2003 Technical Requirements for Protective Face Mask for Medical Use 1 Scope This Standard specifies the technical requirements, test methods, markings and instructions for use, packaging, transportation and storage for protective face mask for medical use (hereinafter referred as mask). This Standard is applicable to non-powered air-purifying medical protective face mask - used in medical service environments to filter particulate matters in air and to separate spray, blood, body fluid, secretion, etc. 2 Normative References Those provisions contained in following documents, through quotation of this Standard, constitute the provisions of this Standard. For dated document, subsequent amendments (excluding the corrections) or revisions of the document do not apply. However, parties who have signed agreement based on these standards are encouraged to investigate the possibility of adopting the most recent editions of the standards indicated below (subsequent amendments or revisions). For any undated documents, the latest edition of the document applies. GB/T 191 Packaging-Pictorial Marking for Handling of Goods GB/T 2428-1998 Head-face Dimensions of Adults GB/T 4745-1997 Textile Fabrics-Determination of Resistance to Surface Wetting-Spray Test GB/T 5549-1990 Surface Active Agents Determination of Surface Tension by Drawing up Liquid Films GB/T 14233.1-2008 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 16886.10-2005 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Delayed-type Hypersensitivity GB/T 18664-2002 Selection, Use and Maintenance of Respiratory Protective Equipment YY/T 0691-2008 Clothing for Protection against Infectious Agents-Medical Face Masks-Test Method for Resistance against Penetration by Synthetic Blood (Fixed Volume, Horizontally Projected) YY/T 0700-2008 Clothing for Protection against Contact with Blood and Body Fluids-Determination of the Resistance of Protective Clothing Materials to Penetration by Blood and Body Fluids-Test Method Using Synthetic Blood 3 Terms and Definitions For the purposes of this Standard, the following terms and definitions apply. 3.1 Filtering efficiency The percentage number of filtering particulate matters in air under specified conditions 3.2 Fit The degree of mask periphery fitting to the face of a specific user 3.3 Fit factor The ratio of the testing agent’s concentration outside the mask to the testing agent’s concentration leaking into the mask, which is quantitatively measured during the testees wearing masks for simulating actions, process and operation 4 Technical Requirements 4.1 Basic requirement of mask The mask shall cover the wearer's nose and mouth and shall be of a good facial fit and without broken holes, stain or expiratory valve. 4.2 Nasal splint 4.2.1 The mask shall have a nasal splint. 4.2.2 The nasal splint shall be adjustable. 4.3 Mask harness 4.3.1 The mask’s harness shall be adjustable conveniently. 4.3.2 The mask’s harness shall be of sufficient strength to fix the mask. The breaking strength of the junction between each mask harness and the mask body shall not be less than 10N. 4.4 Filtering efficiency With the gas flow at 85L/min, the filtering efficiency of mask to non-oily particles shall comply with the requirements specified in Table 1. Table 1 Filtering Efficiency Gradation Gradation Filtering efficiency % Grade 1 ≥95 Grade 2 ≥99 Grade 3 ≥99.97 4.5 Gas flow resistance With the gas flow at 85L/min, the mask inspiration resistance shall not exceed 343.2Pa (35mmH2O). 4.6 Synthetic blood penetration With spraying 2mL synthetic blood on the mask at 10.7 kPa in pressure, no penetration shall occur to the inner side of the mark. 4.7 Surface wetting resistance The outside surface spray rating of the mask shall not be less than those specified in Grade 3 of GB/T 4745-1997. 4.8 Microorganism indexes 4.8.1 The mask shall meet the microorganism index requirement of GB 15979-2002, as detailed in Table 2. 4.8.2 Masks with letters concerning sterilization or asepsis marked on the packaging shall be aseptic. Table 2 Microorganism Indexes of Mask Total bacterial colony count CFU/g Coliform bacteria Pseudomonas aeruginosa Staphylococcus aureus Hemolytic streptococcus Total fungus colony count CFU/g ≤200 Not detectable Not detectable Not detectable Not detectable ≤100 4.9 Oxirane residue The oxirane residue of oxirane-sterilized masks shall not exceed 10μg/g. 4.10 Flame retardation The materials used shall not be of flammability and their continuous-flaming time shall not exceed 5s. 4.11 Skin irritation The primary irritation scoring of the mask materials shall not exceed 1. 4.12 Fit The mask shall be so designed to provide a good fit and the overall fit factor of the mask shall not be less than 100. 5 Test Methods 5.1 Basic requirement of mask Take 3 masks and observe at 300 lx~700 lx. They shall meet the requirement of 4.1. 5.2 Nasal splint It shall be adjusted as specified in the instructions and shall comply with 4.2. 5.3 Mask harness 5.3.1 Sample quantity: take and unpack 4 masks – two of them shall undergo temperature pretreatment; and the other two do not undergo temperature pretreatment. 5.3.2 Condition for temperature pretreatment: Pretreatment condition: a) Keep in 70℃±3℃ environment test chamber for 24h; b) Keep in-30℃±3℃ environment test chamber for 24h. After temperature pretreatment, keep at room temperature for at least 4h. 5.3.3 The result of visual inspection and the result measured by tension test device shall meet the requirement of 4.3. 5.4 Filtering efficiency and gas flow resistance test 5.4.1 Sample quantity: take 6 mask samples for the test. Three of them shall undergo temperature pretreatment and the other three do not undergo temperature pretreatment. 5.4.2 Condition for temperature pretreatment: Pretreatment condition: a) Keep in 70℃±3℃ environment test chamber for 24h; b) Keep in-30℃±3℃ environment test chamber for 24h. After temperature pretreatment, keep at room temperature for at least 4h. 5.4.3 The gas flow shall be stabilized 85L/min±2L/min. The distribution of particle size of sodium chloride (NaCl) aerosol used under the specified test condition shall be such that the count median diameter (CMD) is 0.075μm±0.020μm, geometric standard deviation does not exceed 1.86 (equivalent to 0.24μm±0.06μm in mass median aerodynamics diameter (MMAD)), and concentration does not exceed 200 mg/m3. 5.4.3.1 The determination results of filtering efficiency shall meet all the requirements of 4.4. 5.4.3.2 The determination results of inspiration resistance shall meet all the requirements of 4.5. 5.5 Synthetic blood penetration 5.5.1 Sample quantity: 5 mask samples shall be taken for the test. 5.5.2 Pretreatment condition: the mask samples shall undergo pretreatment for at least 4h in an environment test chamber at 21℃±5℃ in temperature and 85%±5% in relative humidity. The test shall be carried out within 1min after the mask samples' withdrawal from the chamber. 5.5.3 As the test is carried out in accordance with the test method in YY/T 0691-2008, the result shall meet those provisions specified in 4.6. See Appendix A for the preparation of synthetic blood. 5.6 Surface wetting resistance test Three masks shall be taken for the test. As the test is carried out by reference to the method specified in GB/T 4745-1997, the result shall meet the requirement of 4.7. 5.7 Microorganism index 5.7.1 As the test is carried out in accordance with the method specified in Appendix B of GB 15979-2002, the result shall meet the requirement of 4.8.1. 5.7.2 Masks marked as sterilized and aseptic shall undergo the test in accordance with the method specified in GB/T 14233.2-2005 and the result shall meet the requirement of 4.8.2. 5.8 Oxirane residue 5.8.1 Gas chromatograph condition The gas chromatograph shall meet the following conditions: a) Hydrogen flame detector: not less than 2×10-11g/s in sensitivity [benzene, carbon bisulfide (CS2)]. b) Chromatographic column: the chromatographic column used shall be such that the impurities in the specimen can be completely separated from oxirane and shall be, to some extents, water resistant. The chromatographic column may select the conditions recommended in Table 3. Table 3 Recommended Conditions for Chromatographic Column Column length Inside diameter Supporter Column temperature 1m~2m 2mm~3mm GDX-407 177μm~147μm(mesh: 80~100) About 130℃ Porapak q-s 177μm~147μm(mesh: 80~100) About 120℃ c) Temperature of apparatus components Chamber of gasification: 200℃; Test chamber: 250℃. d) Gas flow N2: 15mL/min~30mL/min; H2: 30mL/min; Air: 300mL/min. 5.8.2 Test procedure Parallel tests shall be carried out with water as the solvent and in accordance with 9.4 of GB/T 14233.1-2008 and the exhaustive extraction method specified in Appendix G of GB 15980-1995. And the determination shall be carried out in accordance with 9.5.2 of GB/T 14233.1-2008 and relative content method specified in Appendix G of GB 15980-1995. The results shall be calculated in arithmetic mean. For example, if a portion is qualified while the other is unqualified, mean calculation shall not be carried out and redetermination shall be carried out. The results shall meet the requirement of 4.9. 5.9 Flame retardation 5.9.1 Sample quantity: take 4 mask samples for the test. Two of them shall undergo temperature pretreatment and the other two do not. 5.9.2 Condition for temperature pretreatment: Pretreatment condition: a) Keep in air at 70℃±3℃ for 24h; b) Keep in air at -30℃±3℃ for 24h. After temperature pretreatment, keep at room temperature for at least 4h. 5.9.3 Procedure: 5.9.3.1 Put the mask on a metal head model. The distance between the burner top and mask bottom (with the mask located directly towards the burner) shall be 20mm± 2mm. 5.9.3.2 The flame height shall be adjusted to 40mm± 4mm. The flame temperature measured with a metal-isolated thermocouple probe and at 20mm± 2mm above the burner top shall be 800℃±50℃. 5.9.3.3 Let the head model pass through the flame at lineal speed 60mm/s±5mm/s and record the combustion states of the mask after each passing. The result shall meet the requirement of 4.10. 5.10 Skin irritation As the test is carried out in accordance with the primary skin irritation method specified in GB/T 16886.10-2005, the result shall meet those requirements specified in 4.11 of this Standard. 5.11 Fit Select 10 testees; put on the masks in accordance with the instructions for use; perform 6 required actions. At least 8 testees, tested by the method specified in Appendix B, shall meet the requirement of the overall fit factor. 6 Markings and Instructions for Use 6.1 Markings 6.1.1 Marking on the smallest package of mask The smallest package of mask shall include at least the following clear and distinguishable markings. If the package is transparent, these markings shall be visible through the package. a) Product name and model; b) Name of manufacturer or supplier; c) Reference to standard; d) Product registration number; e) Filter material grade or description; f) Letters or symbols indicating "Refer to Instructions for Use before Use"; g) Storage conditions and guarantee period; h) Letters indicating "Disposable" or equivalent shall be marked on disposable products; i) The sterilization validity period and sterilization mode shall be indicated on sterilized products. 6.1.2 Marking on packing container: The packing container shall be provided at least with the following details or marks: a) Name and address of manufacturer or supplier; b) Product name and model; c) Reference to standard; d) Product registration number; e) Specification and quantity; f) Production date or batch number; g) Lettering and marking like Sun Protection and Keep Dry (the marking shall meet those specified in GB/T 191); h) Storage conditions and validity period. 6.2 Instructions for use The instructions for use shall be at least in Chinese and shall provide the following details: a) Application and service restrictions; b) Denotation of product color code (if applicable); c) Inspection required before use; d) Wear fitness; e) Usage; f) Storage conditions; g) Implication of symbol and (or) diagram applied; h) Possible problems and cautions; i) Recommendation on service time of mask; j) Reference to standard; k) Product registration number. 7 Packaging And Storage 7.1 Packaging 7.1.1 The packaging shall prevent mask from mechanical damage and pollution before use. 7.1.2 The masks shall be encased as per quantity. 7.2 Storage The storage shall be carried out according to the instructions for use. Appendix A (Informative) Preparation of Synthetic Blood A.1 Reagents Prepare 1L synthetic blood according to the following composition: Carboxymethyl cellulose sodium [e.g., CMC-Sigma 9004-32-4 medium viscosity] 2g Polyoxyethylene (20) sorbitan monolaurate {e.g., Tween-20[Fluka 9377]} 0.04g Sodium chloride (analytical grade) 2.4g Amaranth dye [e.g., Sigma 915-67-3](915-67-3) 1.0g Monopotassium phosphate (KH2PO4) 1.2g Disodium hydrogen phosphate (Na2 HPO4) 4.3g Distilled water or deionized water To 1L Note 1: 2-Methyl-4-isothiazolin-3-one hydrochloride (MIT) (0.5 g/L) may be added in the synthetic blood to extend the storage period of the solution. Note 2: Sigma 9004-32-4, Fluka 9377, Sigma 915-67-3 and Fluka 9377 are examples for applicable commercial products. This information allows for the user of this Standard but not represents the recognition of those products. A.2 Preparation Make carboxymethyl cellulose sodium dissolved in 0.5 L water and make them mixed completely with a magnetic stirrer for 60min. Use a small beaker to weigh Tween 20 and make it completely mixed with water. Add the Tween 20 solution in the carboxymethyl cellulose sodium solution. The beaker shall be cleaned with distilled water for several times and the water used shall be incorporated in the former solution. Make NaCl dissolved in the solution. Make KH2PO4 and Na2HPO4 dissolved in the solution. Add MIT (if applied) and amaranth dye. Dilute the solution with water to approximately 1000mL. Regulate the synthetic blood to pH 7.3 ± 0.1 and scale to 1000mL with phosphate buffer. As the surface tension of synthetic blood is measured in compliance with GB/T 5549-1990, the result shall be 0.042N/m±0.002N/m. Appendix B (Normative) Fitness Test Method B.1 Test environment The test space size shall allow for the testee to perform specified testing actions freely. The number of particles in air shall not be less than 70×106 particles/m3If the number of particles is too small, an aerosol generator may be adopted to increase the particles in environment and as for the particles from the aerosol generator, the count median diameter (CMD) is about 0.04μm and geometric standard deviation is about 2.2 (equivalent to 0.26μm in mass median aerodynamics diameter (MMAD)). If sodium chloride aerosol is used, the relative humidity of air shall not be greater than 50%. B.2 Installing mask sampling tube Puncture at the location "respiratory area", near to the wearer's mouth and nose, to install a sampling tube. The sampling tube shall be mounted on the neck support device of testee to reduce the interference to the mask in the test process. B.3 Test procedure Select 10 testees with men and women in fifty-fifty percent respectively. Their headforms shall be in compliance with the Chinese headform series of GB/T 2428-1998. For male, their beard shall be shaved. Wear the mask according to the instructions for use. Before testing, inspection for moving of mask, over-looseness or over-tightness of mask harness, fitness of nasal splint for nose bridge and leakage from mask periphery shall be carried out. No readjustment is allowed in the test process. The testees are required to perform the following 6 actions, each of which shall last for 1min: a) Normal respiration——keep standing, normal respiration speed and speechless. b) Deep breathing ——keep standing, take a deep breath gradually, do not exhale excessively. c) Turning left and right——keep standing, turn head to one side until to the extreme position and then turn to the other side. At each extreme position, inspiration shall be performed. d) Turning up and down——head down slowly and then up slowly. At the upper extreme position, inspiration shall be performed. e) Speaking ——speak loudly and slowly. Ask the testees to count down from 100 or read an article. f) Normal respiration ——see a). B.4 Calculating fit factor B.4.1 The fit factor of each action is calculated from the ratio of the mean concentration of particles outside the mask to that inside the mask, which is determined through calculation. B.4.2 The mean concentration of particles outside the mask may adopt the arithmetic mean of the before-and after-test (6 actions) concentrations or the mean concentration before and after each action, or the actual mean of continuous measurement. B.4.3 The concentration of particles inside the mask shall be calculated as follows: a) Mean peak penetration method: use recorder, integrator or computer to determine the number of particles that passed through the mask. In each action, work out the mean peak height from the recording paper or integrate with computer to determine the number of particles. Selectively, use an integrator or computer to work out the actual number of particles that passed through the mask. b) Maximum peak penetration method: use banding recorder to determine the number of particles that pass through the mask. The peak of each required action represents the mean number of particles that passed through the mask for the action. c) Area integration method: integrate the area of the peak of each action. It includes computer integration. d) Overall fit factor calculation: convert the fit factors of each action to penetration values and work out their mean which is then reconverted to fit factor, as detailed in Formula (B.1). fedcba ffffffffffff FF /1/1/1/1/1/1  (B.1) Where: FF——the overall fit factor; ffa——the fit factor of normal respiration; ffb——the fit factor of deep breathing; ffc——the fit factor of turning-left and right; ffd——the fit factor of turning-up and down; ffe——the fit factor of speaking; fff——the fit factor of normal respiration. References and Original Chinese Documents [1] GB 19083-2010 Technical requirements for protective face mask for medical use. ......

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