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YY 0469-2023 related PDF English

YY 0469-2023 (YY0469-2023) & related versions
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YY 0469-2023English230 Add to Cart 0-9 seconds. Auto delivery. Sterile drainage catheters and accessory devices for single use YY 0469-2023 Valid YY 0469-2023
YY 0469-2011English85 Add to Cart 0-9 seconds. Auto delivery. Surgical mask YY 0469-2011 Valid YY 0469-2011
YY 0469-2004English559 Add to Cart 4 days Technical requirements for surgical mask YY 0469-2004 Obsolete YY 0469-2004
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YY 0469-2023: PDF in English
YY 0469-2023 YY MEDICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.140 CCS C 48 Replacing YY 0469-2011 Surgical mask ISSUED ON: NOVEMBER 22, 2023 IMPLEMENTED ON: DECEMBER 01, 2026 Issued by: National Medical Products Administration Table of Contents Foreword ... 3 1 Scope ... 5 2 Normative references ... 5 3 Terms and definitions ... 5 4 Technical requirements ... 6 5 Test methods ... 8 6 Marks ... 12 7 Marks, transportation and storage ... 13 Annex A (normative) Preparation method for synthetic blood ... 14 Annex B (normative) Test method for bacterial filtration efficiency (BFE) ... 15 Bibliography ... 21 Surgical mask 1 Scope This document specifies the technical requirements, test methods, marks, packaging, transportation and storage for surgical masks. This document is applicable to disposable medical masks worn by medical staff in medical environments with potential risks of blood, body fluid, and secretion contamination and in invasive operating environments. This document does not apply to protective masks in medical and other working environments. 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 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 YY/T 0691-2008, Single-use medical face mask Part IV of Edition 2020 of the Pharmacopoeia of the People's Republic of China 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 surgical mask A barrier that can cover the wearer's mouth, nose and jaw, and is used to prevent pathogenic microorganisms and droplets exhaled by the wearer from directly contaminating the patient or the surrounding environment, and to prevent the patient's body fluids, blood and other splashes from penetrating the mask and affecting the wearer. cause some damages. 3.2 synthetic blood A mixture of red dye, surfactant, thickener, and distilled water whose surface tension and viscosity can represent blood and other body fluids and have a color similar to blood. NOTE: The synthetic blood used in the tests in this document does not have all the characteristics of blood or body fluids, such as polarity (wetness), coagulability, and cellular material. 3.3 particle filtration efficiency; PFE Under specified testing conditions, the percentage of particulate matter filtered out by the mask. 3.4 bacterial filtration efficiency; BFE Under specified testing conditions, the mask's ability to filter out bacteria-containing suspended particles. NOTE: Usually, it is expressed as a percentage. 3.5 flame retardation properties The ability to prevent itself from being ignited, flaming and smoldering. 3.6 airflow resistance The resistance of the mask under the specified area and specified flow rate. NOTE: It is expressed as pressure difference per unit area. 4 Technical requirements 4.1 Appearance The appearance of the mask shall be neat and in good shape. There shall be no damage or stains on the surface. 4.2 Structure and dimension After the mask is worn, it shall cover the wearer's mouth, nose and chin. It shall comply with the design dimensions and allowable deviations specified by the manufacturer. The design of the mask shall be able to distinguish the direction of its inner and outer sides. 4.3 Nose clip 4.3.1 The mask shall be equipped with a nose clip or a design that replaces the nose clip. 4.3.2 Nose clips shall be made of malleable material. It shall be safe and secure, with no sharp protrusions. The length shall be no less than 8.0 cm. If a design is used to replace the nose clip, the design shall be able to fix the nose clip and provide a basic seal when worn. 4.4 Mask strap 4.4.1 Earhook mask The sum of the breaking strengths of each mask strap and the two connection points between each mask strap and the mask body shall not be less than 15 N. 4.4.2 Strap mask The breaking strength of each mask strap and the connection between each mask strap and the mask body shall be no less than 10 N. If there is no fixed connection point between the mask strap and the mask body, the breaking strength of each mask strap shall be no less than 10 N. 4.5 Resistance to synthetic blood penetration After 2 mL of synthetic blood is sprayed onto the outer side of the mask at a pressure of 16.0 kPa (120 mmHg), there shall be no penetration on the inner side of the mask. 4.6 Filtration efficiency 4.6.1 Bacterial filtration efficiency (BFE) The bacterial filtration efficiency of the mask shall be no less than 98%. 4.6.2 Particle filtration efficiency (PFE) The filtration efficiency of the mask against non-oily particles shall be no less than 80%. 4.7 Airflow resistance The airflow resistance for gas exchange on both sides of the mask shall be less than 60 Pa. 4.8 Flame retardation properties Mask materials shall be made of non-flammable materials. The mask shall not burn for more than 5 s after leaving the flame. 4.9 Microbial indicators 5.8 Flame retardation properties Number of samples: Use at least 3 samples for testing. Test process: The distance between the top of the burner and the lowest part of the sample is set to (20±2) mm. Set the flame height to (40±4) mm. The temperature of the flame at (20±2) mm above the burner tip is set to (800±50)℃. Place the sample on the headform. Set the linear speed of the head model at the tip of the nose to (60±5) mm/s. Record the effect of the sample after one pass through the flame. Report the sum of the afterburning time (the time the material continues to burn with flame after the ignition source is removed) and the smoldering time (the time the material continues to burn without flame after the flaming combustion terminates, or after the ignition source is removed). 5.9 Microbial indicators 5.9.1 Microbiological limits The test is conducted in accordance with the membrane filtration method specified in Microbial Enumeration Method in Microbial Limit Examination of Non-sterile Products (General Chapter 1105) in Part IV of Edition 2020 of the Pharmacopoeia of the People's Republic of China. The results for total aerobic bacteria, mold and yeast counts are added together. Preparation of test solution: At least 2 smallest packages are randomly selected. Take no less than 10 g of the test sample. Cut into pieces and use a diluent containing 0.1% (mL/mL) 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. Prepare a 1:50 (g/mL) test solution. Mix thoroughly. 5.9.2 Sterility Carry out in accordance with the test methods specified in the Sterility Inspection Act (General Chapter 1101) in Part IV of Edition 2020 of the Pharmacopoeia of the People's Republic of China. The treatment of the test article and the inoculation culture medium shall be carried out according to the provisions of dressing the test article in the direct inoculation method. 5.10 Residual amount of ethylene oxide Conduct the test in accordance with the provisions of 9.4 in GB/T 14233.1-2022. 5.11 Biocompatibility 5.11.1 Sample preparation Take the mask tape and the main mask material and mix them according to the area ratio of 1:3 as a test sample. The leach solution of this test sample is prepared in accordance with the requirements of GB/T 16886.12. 5.11.2 Cytotoxicity After the test sample extract is diluted 2 times with complete cell culture medium, the cytotoxicity test is carried out according to the MTT method in GB/T 16886.5. 5.11.3 Skin irritation The test is conducted using the animal skin irritation test specified in GB/T 16886.10. 5.11.4 Delayed hypersensitivity reaction The maximum dose for delayed hypersensitivity reaction in guinea pigs specified in GB/T 16886.10 is used for the test. 6 Marks The minimum sales unit of masks shall have clear Chinese marks. The mark shall at least include: a) product name; b) model, specifications and information showing dimensions; c) production date and/or batch number; d) use period or expiry date; e) manufacturer’s name and contact information; f) implementation standard number or product technical requirement number; g) product registration certificate number; h) identification of the inner and outer sides and instructions on how to wear them; i) storage conditions; j) "single-use" words or symbols; k) if it is a sterilized product, there shall be a corresponding sterilization mark and the sterilization method used; l) product purpose. Annex A (normative) Preparation method for synthetic blood A.1 Reagents The formula for synthetic blood consists of the following: Sodium carboxymethyl cellulose (CMC, medium viscosity): 2 g Tween 20 or equivalent other surfactant: 0.06 g or an amount of other surfactant Sodium chloride (analytical grade): 4.5 g Methylisothiazolone (MIT): 0.5 g Amaranth dye: 1.0 g Distilled water: add to 1 L A.2 Preparation method Dissolve sodium carboxymethylcellulose in 0.5 L of water. Mix on a magnetic stirrer until completely dissolved. Weigh Tween 20 or equivalent other surfactant in a small beaker and add water and mix well. Add Tween 20 solution or equivalent other surfactant to the above solution of sodium carboxymethyl cellulose. Wash the beaker several times with distilled water and add to the previous solution. Dissolve sodium chloride in the solution. Add MIT and amaranth dye. Dilute with water to 1000 g. Adjust the pH of the synthetic blood to 7.3±0.1 with 2.5 mol/L sodium hydroxide solution. Use a surface tensiometer to measure the surface tension of synthetic blood. The result shall be (0.042±0.002) N/m. If it is outside this range, it cannot be used. Erlenmeyer flask (250 mL~500 mL). Petri dish. Pipettes (1 mL, 5 mL, 10 mL). Sterile glass bottle (100 mL~500 mL). Inoculation loop. Test tube stopper. Test tube (16 mm×150 mm). B.1.3 Reagents B.1.3.1 The formula of tryptic soy peptone agar medium (TSA) is as follows (taking 1 000 mL as an example): a) Tryptone: 15 g; b) Soybean papain hydrolysate: 5 g; c) Sodium chloride: 5 g; d) Agar: 15 g; e) Final pH 7.3±0.2 (25℃). B.1.3.2 The formula of tryptic soybean liquid medium (TSB) is as follows (taking 1 000 mL as an example): a) Tryptone: 17 g; b) Soybean papain hydrolysate: 3 g; c) Sodium chloride: 5 g; d) Dipotassium hydrogen phosphate: 2.5 g; e) Glucose: 2.5 g; f) Final pH 7.3±0.2 (25℃). B.1.3.3 The formula of peptone water is as follows (taking 1 000 mL as an example): a) Peptone: 10 g; b) Sodium chloride: 5 g; c) Final pH 7.2±0.2 (25℃). B.1.3.4 Staphylococcus aureus (ATCC 6538). B.2 Sample pretreatment Before the test, place the sample in an environment with a temperature of (21±5)℃ and a relative humidity of (85±5)% for at least 4 h. B.3 Preparation of bacterial suspension for testing Staphylococcus aureus (ATCC 6538) is inoculated into an appropriate amount of TSB medium. Incubate at (37±2)℃ for (24±2) h with shaking. Dilute the above culture with peptone water to a concentration of approximately 5×105 CFU/mL. B.4 Test procedures Do not put the sample into the test system first. The gas flow rate through the sampler is controlled at 28.3 L/min. The time for delivering bacterial suspension to the nebulizer is set to 1 min. The air pressure and sampler run time are set to 2 min. Collect bacterial aerosol onto TSA medium as a positive control. After the test is completed, take out the agar plate and mark it with the layer number. Place a new agar plate. Clamp the test sample to the upper end of the sampler, with the inside of the mask facing the aerosol. Follow the procedure above for sampling. After a batch of test samples has been tested, test the positive control test again. Finally, collect the air sample in the aerosol chamber for 2 min as a negative control. During this process, bacterial suspension cannot be delivered to the nebulizer. A test system (Figure B.2) that can perform positive control collection and sample collection at the same time can also be used, but the consistency between channels shall be ensured. Incubate the agar plate at (37±2)°C for (48±4)h. The colony-forming units formed by the aerosol of bacterial particles are then counted (r). Use the sampling hole conversion table (Table B.1) to convert it to the corrected particle count value P (levels 1 and 2 are not corrected). The sum of the values at all levels of the positive control group is used as the positive control value to determine the average level of bacterial aerosol particles delivered to the test sample. The calculation method for the test sample group is the same as that for the positive control group. The number of positive control bacteria shall be controlled between 1700 CFU and 3000 CFU. Otherwise, the spray conditions (spray flow rate or concentration and volume of the transported bacterial solution) need to be adjusted. The average particle diameter (MPS) of bacterial aerosol is calculated according to formula (B.1) and shall be (3.0±0.3) μm. Negative controls shall have no colony growth. ......

BASIC DATA
Standard ID YY 0469-2023 (YY0469-2023)
Description (Translated English) Surgical mask
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C48
Classification of International Standard 11.140
Word Count Estimation -2,-13
Date of Issue 2023-11-22
Date of Implementation 2026-12-01
Older Standard (superseded by this standard) YY 0469-2011
Administrative Organization National Medical Protective Equipment Standardization Working Group (SAC/SWG 30)
Proposing organization State Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the technical requirements, test methods, marking, packaging, transportation and storage of medical surgical masks. This standard applies to disposable medical masks worn by medical staff in medical environments and invasive operating environments that contain potential risks of blood, body fluid, and secretion contamination. This standard does not apply to protective masks in medical and other working environments.