Technical Requirements for Protective Face Mask for Medical Use

Transcription

1 ICS C 44 NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA 中华人民共和国国家标准 GB Replace GB Technical Requirements for Protective Face Mask for Medical Use 医用防护口罩技术要求 How to BUY & immediately GET a full-copy of this standard? Search --> Add to Cart --> Checkout (3-steps); 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your address in 0~60 minutes. 4. Support: Sales@ChineseStandard.net. Wayne, Sales manager Issued on: September 2, 2010 Implemented on: August 1, 2011 Jointly issued by: The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and The Standardization Administration Committee (SAC) of The People s Republic of China

2 Table of Contents Foreword... i 1 Scope Normative References Terms and Definitions Technical Requirements Test Methods Markings and Instructions for Use Packaging And Storage... 7 Appendix A (Informative) Preparation of Synthetic Blood... 8 Appendix B (Normative) Fitness Test Method... 9

3 Foreword In this Standard, Section 4.10 is recommendatory and other Sections are mandatory. This Standard replaces GB "Technical Requirements for Protective Face Mask for Medical Use". Compared with GB , 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 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 was replaced by the gas chromatography method of GB/T ; 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 i

4 NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA 中华人民共和国国家标准 GB Replace Technical Requirements for Protective Face Mask for Medical Use 医用防护口罩技术要求 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 Head-face Dimensions of Adults GB/T Textile Fabrics-Determination of Resistance to Surface Wetting-Spray Test GB/T Surface Active Agents Determination of Surface Tension by Drawing up Liquid Films GB/T Test Methods for Infusion, Transfusion, Injection Equipments for 1

5 Medical Use-Part 1: Chemical Analysis Methods GB/T Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use-Part 2: Biological Test Methods GB Hygienic Standard for Disposable Sanitary Products GB/T Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Delayed-type Hypersensitivity GB/T Selection, Use and Maintenance of Respiratory Protective Equipment YY/T Clothing for Protection against Infectious Agents-Medical Face Masks-Test Method for Resistance against Penetration by Synthetic Blood (Fixed Volume, Horizontally Projected) YY/T 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 The mask shall have a nasal splint The nasal splint shall be adjustable. 4.3 Mask harness The mask s harness shall be adjustable conveniently 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. 2

6 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 Grade Grade Gas flow resistance With the gas flow at 85L/min, the mask inspiration resistance shall not exceed 343.2Pa (35mmH 2 O). 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 Microorganism indexes The mask shall meet the microorganism index requirement of GB , as detailed in Table 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 Oxirane residue The oxirane residue of oxirane-sterilized masks shall not exceed 10μg/g Flame retardation The materials used shall not be of flammability and their continuous-flaming time shall not exceed 5s Skin irritation The primary irritation scoring of the mask materials shall not exceed 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 Test Methods 5.1 Basic requirement of mask Take 3 masks and observe at 300 lx~700 lx. They shall meet the requirement of Nasal splint 3

7 It shall be adjusted as specified in the instructions and shall comply with Mask harness Sample quantity: take and unpack 4 masks two of them shall undergo temperature pretreatment; and the other two do not undergo temperature pretreatment 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 The result of visual inspection and the result measured by tension test device shall meet the requirement of Filtering efficiency and gas flow resistance test 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 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 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/m The determination results of filtering efficiency shall meet all the requirements of The determination results of inspiration resistance shall meet all the requirements of Synthetic blood penetration Sample quantity: 5 mask samples shall be taken for the test 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 As the test is carried out in accordance with the test method in YY/T , 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 , the result shall meet the requirement of Microorganism index As the test is carried out in accordance with the method specified in Appendix B of GB , the result shall meet the requirement of Masks marked as sterilized and aseptic shall undergo the test in accordance with the 4

8 method specified in GB/T and the result shall meet the requirement of Oxirane residue Gas chromatograph condition The gas chromatograph shall meet the following conditions: a) Hydrogen flame detector: not less than g/s in sensitivity [benzene, carbon bisulfide (CS 2 )]. 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 μm~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 N 2 : 15mL/min~30mL/min; H 2 : 30mL/min; Air: 300mL/min Test procedure Parallel tests shall be carried out with water as the solvent and in accordance with 9.4 of GB/T and the exhaustive extraction method specified in Appendix G of GB And the determination shall be carried out in accordance with of GB/T and relative content method specified in Appendix G of GB 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 Flame retardation Sample quantity: take 4 mask samples for the test. Two of them shall undergo temperature pretreatment and the other two do not 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 Procedure: 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 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 5

9 800 ± 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 Skin irritation As the test is carried out in accordance with the primary skin irritation method specified in GB/T , the result shall meet those requirements specified in 4.11 of this Standard 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 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 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 6

10 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 The packaging shall prevent mask from mechanical damage and pollution before use The masks shall be encased as per quantity. 7.2 Storage The storage shall be carried out according to the instructions for use. 7

11 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 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 ]( ) 1.0g Monopotassium phosphate (KH 2 PO 4 ) 1.2g Disodium hydrogen phosphate (Na 2 HPO 4 ) 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 , Fluka 9377, Sigma 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 KH 2 PO 4 and Na 2 HPO 4 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 , the result shall be 0.042N/m±0.002N/m. 8

12 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 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 ]( ) 1.0g Monopotassium phosphate (KH 2 PO 4 ) 1.2g Disodium hydrogen phosphate (Na 2 HPO 4 ) 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 , Fluka 9377, Sigma 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 KH 2 PO 4 and Na 2 HPO 4 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 , the result shall be 0.042N/m±0.002N/m. 8

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