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| What material is the medical protective suit made (19th Dec 22 at 6:53am UTC)
What material is the medical protective suit made of? _ Requirements | | Original title: What materials are medical protective suit made of? Types of medical protective suit. At present, in addition to head, hand and foot protective products, there are mainly three kinds of trunk protective products used in hospitals: isolation clothing, surgical gowns and medical protective suit. Isolation clothing refers to the clothing worn by medical staff in contact with patients, family visits to patients and other occasions; The term "surgical gown" refers to a specially designed garment worn in the operating room; Protective suit refers to the clothing worn by personnel entering special areas such as medical first aid, infectious disease areas and electromagnetic radiation areas. According to the requirements of different use conditions, the three products should meet different performance requirements. Among them, isolation clothing is the first class of medical devices, with the lowest performance requirements. At present, there is no industry standard or national standard in China. Surgical gowns and protective suit are the second class of medical equipment. Our country has established the performance research method of surgical gowns in YY/T 0506 series standards, and the technical requirements of medical disposable protective suit in GB 19082. At present, the standard of reusable medical protective suit has not been established in China. Here we mainly introduce the medical disposable protective suit that meet the requirements listed in the GB 19082, which is also the most needed protective suit in this epidemic. The product is mainly used for medical staff who may contact with potentially infectious patients' blood, body fluids, secretions and airborne particles during work. Material of medical protective suit. Protective suit are typically made from composite materials such as polyester or polypropylene spunlaid nonwovens with breathable microporous films or other nonwovens, or spunlaced nonwovens with breathable microporous films, or wood pulp composite spunlaced nonwoven. At present, polyethylene flash-spun nonwovens and spunbonded/meltblown/spunbonded (SMS) or spunbonded/meltblown/melt-blown/spunbound (SMMS) composite nonwovens are widely used to be compounded with microporous films, and are subjected to functional finishing of "three repellencies and one resistance" (water repellency, blood repellency, alcohol repellency and antistatic property). Nonwovens: Refers to a sheet, web, or batt made of oriented or randomly arranged fibers that are bonded to each other by friction, cohesion, or bonding, or a combination of these methods, excluding paper, woven fabrics, knitted fabrics, tufted fabrics, and wet-felted felts (GB/T 57091997 "Terminology of Textiles and Nonwovens"). To put it simply, it is not interwoven and knitted together one by one, but the fibers are directly bonded together by physical methods, so the non-woven fabric can not pull out a thread. Performance of medical protective suit. Performance requirements for protective suit materials, including protection, serviceability, safety and hygiene. Simply put, protective suit should not only be moisture-proof and breathable, but also protect medical staff from viruses, bacteria and other pollutants in the process of diagnosis and treatment, resist the invasion of water, alcohol and blood, and effectively resist static electricity and even prevent dust from entering. Specifically: ① The protective requirements shall have the function of liquid barrier, the key parts of the protective suit (left and right front, left and right arms and back) shall have water permeability resistance, and the hydrostatic pressure resistance shall not be less than 1.67 kPa; the synthetic blood penetration resistance shall not be less than Grade 2, that is, the synthetic blood shall not penetrate after acting on the protective suit for 5 minutes under the pressure of 1.75 kPa; the water level of the outer side of the protective suit shall not be lower than Grade 3. This technical index is to prevent the patient's blood, or the disinfection water, washing liquid and other liquids during the operation from penetrating the protective suit and polluting the medical workers. Expand the full text ② The protective suit shall have the performance of preventing the penetration of micro-particles, and the filtration efficiency of the key parts and joints of the protective suit for non-oily particles shall not be less than 70%. This technical target is to prevent the invasion of virus-carrying particles (such as spit, etc.). In addition, the seams of protective suit must be sealed to cover the needle holes left by sewing. ③ The serviceability requirements of protective suit include sufficient strength and dimensional stability. During the tensile test, the breaking strength shall not be less than 45 N and the elongation at break shall not be less than 30%. This technical index is to ensure the physical properties of clothing, so that it is not easy to damage.
(4) In terms of wearing comfort of protective suit, the moisture permeability of protective suit materials should not be less than 2500 G/m2 · d. This technical index is to ensure that the sweaty heat of the wearer is discharged in time. ⑤ The safety and hygiene of protective suit require that it is non-toxic, non-irritating to the skin and resistant to the growth of fungi. ⑥ The protective suit is disposable, so it is required to reduce the cost as much as possible while ensuring the protective performance in terms of economy. Medical protective suit related standards, regulations and documents We have collected medical protective suit relevant standards, regulatory requirements, documents and data requirements. Guidelines for Technical Review of medical protective suit Product Registration YY ∕ T 1499-2016 Liquid barrier properties and classification of medical protective suit. GB/T3923.1-2013 Textiles-Tensile properties of fabrics-Part 1: Determination of breaking force and elongation at break-Strip method GB/T127 03.1-2008 Textiles-Assessment of electrostatic properties-Part 1: Electrostatic half-life GB/T127 04.1-2009 Textiles-Test methods for moisture permeability of fabrics-Part 1: Moisture absorption GB/T127 04.2-2009 Textiles-Test methods for moisture permeability of fabrics-Part 2: Evaporation method Sterilization of health care products-Requirements for validation and routine control of sterilization-18278-Industrial moist heat sterilization GB 18279 1, GB/T 18279.2-2015 Ethylene Oxide Sterilization Validation and Routine Control for Medical Devices GB 18280.1-2015, GB 18280.2-2015 Sterilization Validation and Routine Control Requirements for Healthcare Products Radiation Sterilization GB/T 16886.1-2011 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing GB/T 16886.7-2015 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residues GB/T 16886.10-2005 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Delayed Hypersensitivity GB/T 19633 1, GB/T 1963.2-2015 Packaging for terminally sterilized medical devices GB/T 14233.1-2008 Examination Methods for Medical Transfusion, Infusion and Injection Equipment Part 1: Chemical Analysis Methods GB/T 14233.2-2005 Examination Methods for Medical Transfusion, Infusion and Injection Equipment Part 2: Biological Test Method Medical protective suit inspection requirements and inspection agencies The inspection of medical protective suit products includes delivery inspection and type inspection. The factory inspection items shall at least include the following items: appearance, structure and size, breaking strength, elongation at break, microbial indicators, and ethylene oxide residue (if ethylene oxide sterilization is used). Considering the incoming inspection of raw materials and the outgoing inspection of medical protective suit, enterprises should configure basic inspection instruments, such as dynamometer, micrometer, vernier caliper, ruler, etc. If the microbiological indicators and ethylene oxide residues are self-tested, a microbiological laboratory and corresponding instruments are required. The type inspection shall be the full performance inspection of the product technical requirements, and the medical device inspection Institute approved by the Food and Drug Administration shall be selected. The General Administration of Market Supervision has published a list of state-level qualified inspection and testing institutions for medical devices and protective articles. The General Administration of Market Supervision (CNCA) announces the list of inspection and testing institutions of medical devices and protective articles with national qualifications. Time: 2020-02-07 Source: Website of the General Administration of Market Supervision In order to strengthen the quality and safety supervision of protective articles, give full play to the technical support role of inspection and testing in epidemic prevention and control, and meet the needs of inspection and testing of protective articles, the inspection and testing institutions of medical devices protective articles that have obtained qualification certification through the approval of the National Certification and Accreditation Regulatory Commission are now published in a centralized manner (the specific list is attached).
There are 55 such institutions, of which 30 have the ability to detect medical disposable protective suit, 34 have the ability to detect medical protective masks, 28 have the capability to detect surgical mask, 24 have the capability to detect disposable medical masks, 34 have the capabilit y to detect disposable sterilized rubber surgical gloves, and all of them are equipped with medical protective masks. 34 companies have the ability to detect disposable medical rubber inspection gloves. In addition, there are more than 170 inspection and testing institutions for protective equipment that have been certified by provincial market supervision departments, and units or individuals in need can consult local market supervision departments or relevant inspection and testing institutions. Epidemic is the order, and prevention and control is the responsibility. Relevant inspection and testing institutions should conscientiously implement the major decisions and arrangements of the CPC Central Committee and the State Council on the prevention and control of the new coronavirus pneumonia epidemic, stick to their posts, open a green channel for the inspection and testing of protective articles, do a good job in the inspection and testing of protective articles during the epidemic prevention and control period, and provide accurate, fast and high-quality technical support services for consumers and users.
Appendix: Directory of Inspection and Testing Institutions for Protective Articles of Medical Devices Accreditation and Testing Department of the General Administration of Market Supervision February 7, 2020 Enclosure Directory of Inspection and Testing Institutions for Protective Equipment of Medical Devices No. Name of organization Certificate No. Address of test item Telephone No. 1 Beijing Medical Equipment Inspection Institute (Beijing Medical Equipment Quality Supervision and Inspection Center of State Food and Drug Administration) Medical disposable protective suit, medical protective masks, surgical mask, disposable medical masks, disposable sterilized rubber surgical gloves, Disposable medical rubber inspection gloves No.7, Xingguang 2nd Street, Tongzhou Park Optical-mechanical-electrical Integration Industrial Base, Zhongguancun Science Park, Tongzhou District, Beijing 2 Yunnan Institute of Medical Equipment Inspection Medical disposable protective suit, medical protective mask, surgical mask, disposable medical mask, disposable sterile rubber surgical gloves,3 Ply Disposable Protective Face Mask, disposable medical rubber inspection gloves No.616, Kefa Road, High-tech Development Zone, Wuhua District, Kunming City, Yunnan Province Medical disposable protective suit, medical protective mask, surgical mask, disposable medical mask, disposable sterilized rubber surgical gloves, disposable medical rubber inspection gloves of Shaanxi Institute for Quality Supervision and Inspection of Medical Instruments Southwest corner of Xingxian Road and Fengjing Road, Fengxi New Town, Qindu District, Xianyang City, Shaanxi Province 4 Heilongjiang Provincial Center for Drug Control and Research (Heilongjiang Provincial Center for Medical Device Testing and Research) Disposable medical protective suit, medical protective mask, surgical mask, disposable sterilized rubber surgical gloves, disposable medical rubber examination gloves No.711 Wanggang Street, Nangang District, Harbin City, Heilongjiang Province 5 Fujian Medical Equipment and Drug Packaging Material Inspection Institute Medical Disposable protective suit, Medical Protective Masks, surgical mask, Disposable Medical Masks, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Examination Gloves Building 8, 330 Tonghu Road, Gulou District, Fuzhou City, Fujian Province Disposable medical protective suit, medical protective mask, surgical mask, disposable medical mask, disposable sterilized rubber surgical gloves, disposable medical rubber examination gloves, No.8, Xinwen Road,KN95 Face Mask with Five Layers, West District, Chengdu High-tech Industrial Development Zone, Chengdu City, Sichuan Province 7 Hebei Medical Equipment and Drug Packaging Material Inspection Institute Medical Disposable protective suit, Medical Protective Masks, surgical mask, Disposable Medical Masks, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.228, Zhonghua North Street, Xinhua District, Shijiazhuang City, Hebei Province 8 Guangdong Institute for Quality Supervision and Inspection of Medical Devices/State Food and Drug Administration Guangzhou Center for Quality Supervision and Inspection of Medical Devices Medical disposable protective suit, medical protective mask, surgical mask, disposable medical mask, disposable sterilized rubber surgical gloves, disposable medical rubber inspection gloves No.1, Guangxue West Road, Science City, Huangpu District, Guangzhou City, Guangdong Province 9 Anhui Institute for Food and Drug Control Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.15 Urumqi Road, Baohe District, Hefei City, Anhui Province 10 State Food and Drug Administration Shanghai Medical Device Quality Supervision and Inspection Center/Shanghai Medical Device Inspection Institute Medical Disposable protective suit, Medical Protective Masks, surgical mask, Disposable Medical Masks No.1, Jinyinhua Road, Pudong New Area, Shanghai 11 Tianfangbiao Testing and Certification Co., Ltd. Medical Disposable protective suit No.25 Queqiao Road, Nankai District, Tianjin Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves 600-1, Maizitun, Hunnan District, Shenyang City, Liaoning Province/Shenyang Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration 600-2, 600-3
13 Tianjin Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration/Tianjin Medical Device Quality Supervision and Inspection Center Medical Disposable protective suit, Medical Protective Masks, surgical mask No.5, Haitai Huake Street, Xiqing District, Tianjin National Center for Quality Supervision and Inspection of Medical X-ray Machine No.600-1, 600-2, 600-3, Maizitun, Hunnan District, Shenyang City, Liaoning Province Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves 15 Guangzhou Inspection and Testing Certification Group Co., Ltd. Medical disposable protective suit, medical protective masks, surgical mask, disposable medical masks, disposable medical rubber inspection gloves, No.1-2, Zhujiang Road, Chaotian Industrial Zone, Shilou, Medical Quickly Delivery Antivirus Coverall ,Virus Prevention Mask 3 Ply with Earloop, Panyu District, Guangzhou City, Guangdong Province 16 National Garment Quality Supervision and Inspection Center (Tianjin) Medical Disposable protective suit No.25 Queqiao Road, Nankai District, Tianjin 17 National Medical Equipment Quality Supervision and Inspection Center Medical Disposable protective suit, Medical Protective Masks, surgical mask, Disposable Medical Masks No.1, Jinyinhua Road, Pudong New Area, Shanghai 18 National Medical Equipment and Pharmaceutical Machinery Quality Supervision and Inspection Center Medical Disposable protective suit, Medical Protective Masks, surgical mask No.5 Haitai Huake Street, Xiqing District, Tianjin 19 National Textile Apparel Product Quality Inspection Center (Guangzhou) Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask No.1-2, Zhujiang Road, Chaotian Industrial Zone, Shilou Town, Panyu District, Guangzhou City, Guangdong Province 20 National Center for Quality Supervision and Inspection of Wadding Fiber Products Medical Disposable protective suit and Medical Protective Masks No.6, No.2, Keji West Road, Nankai District, Tianjin 21 China Institute for Food and Drug Control (China General Institute for Drug Control) Medical Disposable protective suit, No.31 Huatao Road, Daxing District, Beijing 22 National Plush Quality Supervision and Inspection Center Medical Disposable protective suit Planning Road, Hongsheng Industrial Park, Xincheng District, Hohhot City, Inner Mongolia Autonomous Region National Knitting Product Quality Supervision and Inspection Center Medical Disposable protective suit No.25 Queqiao Road, Nankai District, Tianjin 24 Henan Medical Equipment Inspection Institute Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves No.79, Xiongerhe Road, Zhengdong New District, Zhengzhou City, Henan Province 25 National Rehabilitation Aids Quality Supervision and Inspection Center Medical Disposable protective suit and Medical Protective Masks No.1 Ronghua Middle Road, Daxing Economic and Technological Development Zone, Beijing 26 Hubei Institute of Quality Supervision and Inspection of Medical Devices Medical disposable protective suit, medical protective mask, surgical mask, disposable medical mask, disposable sterilized rubber surgical gloves, disposable medical rubber inspection gloves No.507, Gaoxin Avenue, Donghu New Technology Development Zone, Wuhan City, Hubei Province 27 Jilin Institute of Medical Equipment Inspection (Jilin Medical Equipment Clean Environment Monitoring Center, Jilin Medical Equipment Quality Certification Center) Medical disposable protective suit, medical protective masks, surgical mask, disposable medical rubber inspection gloves No.669, Chongwen Road, Luyuan District, Changchun City, Jilin Province 28 China Textile Standard Inspection and Certification Co., Ltd. Medical Disposable protective suit and Medical Protective Masks No.3 Yanjingli Middle Street, Chaoyang District, Beijing 29 State Food and Drug Administration Jinan Medical Equipment Quality Supervision and Inspection Center Medical Disposable protective suit, Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves Jinan High-tech Industrial Development Zone Century Avenue 15166, Jinan City, Shandong Province 30 Guizhou Medical Equipment Testing Center Medical Disposable protective suit, Medical Protective Masks, surgical mask, Disposable Medical Masks, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.70 Baihuashan Road, Guiyang City
31 Hainan Provincial Institute for Drug Control/Hainan Provincial Institute for Medical Device Testing Medical protective mask, medical surgical mask, disposable medical mask, disposable sterilized rubber surgical gloves, disposable medical rubber inspection gloves No.53, Nanhai Avenue, Longhua District, Haikou City, Hainan Province 32 Jiangxi Medical Equipment Testing Center Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Examination Gloves No.181, Nanjing East Road, Nanchang City, Qingshanhu District, Nanchang City, Jiangxi Province 33 National Consumer Goods Quality Supervision and Inspection Center Medical Protective Mask No.900, Jiangyue Road, Minhang District, Shanghai 34 Chongqing Medical Equipment Quality Inspection Center Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.98, Songpai Road, Yubei District, Chongqing 35 National Textile Quality Supervision and Inspection Center Medical Protective Masks No.3, Yanjingli Middle Street, Chaoyang District, Beijing 36 National Labor Protection Products Quality Supervision and Inspection Center (Beijing) Medical Protective Mask No.55 Taoranting Road, Xicheng District, Beijing 37 Medical Protective Mask, surgical mask, Disposable Medical Mask and Disposable Sterilized Rubber Surgical Gloves, Hunan Medical Equipment Inspection and Testing Institute, No.510, Tiyuan Road, Yuhua District, Changsha City, Hunan Province 38 Harbin Food and Drug Inspection and Testing Center Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves East of Nanjing Road, Limin Development Zone, Hulan District, Harbin City, Heilongjiang Province 39 State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center Medical Protective Mask, surgical mask, Disposable Medical Mask, Disposable Sterilized Rubber Surgical Gloves No.379, No.25 Street, Xiasha Economic and Technological Development Zone, Hangzhou 40 Disposable Sterilized Rubber Surgical Gloves and Disposable Medical Rubber Inspection Gloves, Medical Device Testing Center, Guangxi Zhuang Autonomous Region, 13 # Factory Building, Jinkai Industrial Park, No.19, Guokai Avenue East, Nanning Economic and Technological Development Zone, Nanning City, Guangxi Zhuang Autonomous Region 41 Chemical Industry Synthetic Material Aging Quality Supervision and Inspection Center Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.396, Chebei West Road, Tangxia, Tianhe District, Guangzhou City, Guangdong Province 42 Chemical Industry Bicycle Tire Quality Supervision and Inspection Center Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves, No.270, Industrial Avenue, Haizhu District, Guangzhou City, Guangdong Province 43 Jiangsu Medical Device Inspection Institute (Jiangsu Food and Drug Administration Pharmaceutical Packaging Material Container Product Quality Supervision and Inspection Station) Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves No.17, Kangwen Road, Jianye District, Nanjing City, Jiangsu Province 44 Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves, No.818, Xinhua East Road, Hetang District, Zhuzhou City, Hunan Province, Quality Supervision and Inspection Center of Latex Products, Zhuzhou Rubber Research and Design Institute Co., Ltd. Petroleum and Chemical Industry New Materials and Products Quality Supervision and Inspection Center Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves 46 Ningxia Hui Autonomous Region Institute for Drug Control Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves Intersection of Ning'an Street and Fengyue Lane, Jinfeng District, Yinchuan City, Ningxia Hui Autonomous Region 47 Quality Supervision and Inspection Center for Rubber, Plastics and Chemicals of Petroleum and Chemical Industry (Beijing) Disposable Sterilized Rubber Surgical Gloves and Disposable Medical Rubber Inspection Gloves, No.1 Dougezhuang, Chaoyang District, Beijing (Office Address: Building 2, No.6 Huagong Road, Chaoyang District, Beijing) 48 Qingdao Zhijian Inspection Co., Ltd. Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves, No.53 Beijing Road, Free Trade Zone, Huangdao District, Qingdao City, Shandong Province
49 National Tire and Rubber Products Quality Supervision and Inspection Center Disposable Sterilized Rubber Surgical Gloves No.77, Weisi Road, Keyuan, Laoshan District, Qingdao City, Shandong Province 50 Shijiazhuang Customs Technical Center Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves, No.318, Heping West Road, Xinhua District, Shijiazhuang City, Hebei Province 51 China General Chamber of Commerce Department Store Labor Protection Products Quality Supervision and Testing Center (Tianjin) (Tianjin Labor Protection Products Quality Supervision, Inspection and Testing Center) Disposable Sterilized Rubber Surgical Gloves Room 401, Door 2, Block F, Haitai Green Industrial Base, No.6, Haitai Development 6th Road, Huayuan Industrial Zone, Binhai New Area, Tianjin 52 National Rubber and Rubber Products Quality Supervision and Inspection Center (Guangxi) Disposable Sterilized Rubber Surgical Gloves, Disposable Medical Rubber Inspection Gloves, No.12 Tieshan Road, Qixing District, Guilin City, Guangxi Zhuang Autonomous Region 53 National Medical Ultrasonic Instrument Quality Supervision and Inspection Center Disposable Medical Rubber Inspection Gloves No.507, Gaoxin Avenue, Donghu New Technology Development Zone, Wuhan City, Hubei Province 54 Guangzhou Customs Technical Center Disposable Medical Rubber Inspection Gloves Building B, No.66, Huacheng Avenue, Zhujiang New Town, Guangzhou City, Guangdong Provinc 55 National Leather Products Quality Inspection Center (Guangdong) Disposable Medical Rubber Inspection Gloves No.1-2, Zhujiang Road, Chaotian Industrial Zone, Shilou Town, Panyu District, Guangzhou City, Guangdong Province Source: Fibers and Fabrics (This view does not represent the views of this site,Full Body Disposable Coverall, for reference only) The copyright belongs to the original author, if there is infringement or do not agree to reprint, please contact to delete! Return to Sohu to see more Responsible Editor: zjyuan-group.com | |
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