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Medical protective clothing, gloves, goggles, shoes standard interpretation -
Medical protective clothing, gloves, goggles, shoes standard interpretationpanda_commerce_2020-04-18T10:01:54+00:00
Recently, the State, in order to alleviate the grim situation of insufficient supply of medical protective clothing, goggles and other prevention and control materials, has introduced a series of temporary emergency measures related to the prevention and control of the epidemic, which has promptly ensured the safety of front-line medical personnel. Recently, the provincial standardization institute for epidemic prevention and control standard needs, carried out a comparison of the current standard of medical protective footwear, in order to understand the medical protective footwear to provide a more intuitive understanding.
At present, there are many international standards related to medical protection, ISO (International Standardization Association) standards mainly focus on terminology and test methods, while the more general ones are American and EU standards.
The product standards of China’s protective footwear mainly consist of national standards and industry standards, protective clothing, masks, gloves, eye protection and protective shoes related standards are: GB 19082-2009 “Medical disposable protective clothing technical requirements”, GB 2626-2006 “respiratory protection”, GB 19083-2010 “Medical protective masks technical requirements”, GB 7543-2006 “Single-use sterilized rubber surgical gloves”, GB 10213-2006 “Single-use rubber inspection gloves”, GB 14866-2006 “Personal eye protection technical requirements”, GB 21147-2007 “Personal protective equipment protective shoes”.
The U.S. medical standard is the NFPA 1999 “Emergency Medical Incident Scene Protective Clothing” developed by the NFPA (National Fire Protection Association), which is applicable to emergency medical care and establishes minimum standards for the protection of persons against blood and body fluids, dividing the protection of the human body into four categories: head, body (all parts except the head, hands and feet), hands and feet, and products are classified according to these four functions.
(1) Facial protection: including droplet eye protection, helmets with hoods, masks, etc..
(2) Protective clothing.
(3) Isolation belts, aprons, sleeves, etc..
(4) First aid shoes.
The EU standards are set by the CEN (European Commission for Standardization). Including EN 14126-2003 “Performance requirements and test methods for protective clothing against infection”.
In the protective footwear products packaging and labeling, our standards and the United States NFPA 1999, the European Union standards have made more comprehensive and strict provisions.
[Medical protective clothing]
As one of the types of chemical protective clothing, it is mainly worn by medical personnel, which can effectively block microorganisms, block the penetration of bodily fluids and prevent the transmission of diseases.
Our country GB 19082-2009 “Medical disposable protective clothing technical requirements” stipulates that protective clothing consists of hooded top and trousers, divided into one-piece structure and split structure, is not applicable to reusable protective clothing, and provides for the flame retardant performance, water contamination level, charge density, elongation at break and water resistance of medical protective clothing and other indicators.
The protective clothing to which the US NFPA 1999 standard applies is disposable and reusable, including split and one-piece workwear and patient use. In addition to the conventional physical strength performance, flame retardant performance and other indicators, the standard also requires an overall test, the isolation layer and seams are tested for resistance to liquids and microbial transmission.
The European Union’s EN 14126-2003 “Performance requirements and test methods for anti-infection protective clothing” applies to protective clothing for repeatable and limited use, but is not suitable for use by surgeons and patients who are undergoing surgery to avoid cross-infection. It is required that the seams of the protective clothing should meet the strength requirements in EN 14325. The whole set of protective clothing is divided into 6 categories according to the protection performance, from type 1 to type 6, the smaller the number of protection, the higher the protection; type 4 is a medical recommendation requirement, the type with (B) is biological protection, the general priority is to choose with B type protective clothing.
[Rubber gloves]
China’s medical gloves standards are mainly GB 7543-2006 “Single-use sterilized rubber surgical gloves” and GB 10213-2006 “Single-use rubber inspection gloves”, which are equivalent to ISO 10282:2002 “Single-use sterilized rubber surgical gloves” (English version) and ISO 11193.1:2002 “Single-use medical rubber inspection gloves Part 1: gloves made of latex or rubber solution” (English version). The purpose is to protect patients and users from cross-infection during surgical operations and medical examinations or diagnostic treatments, respectively. Both of these are disposable gloves. The two standards primarily test the impermeability and tensile performance of the gloves before and after aging, but there are no anti-virus transmission requirements or test methods. NFPA 1999 is mainly for the protection of first responders, requiring the testing of liquid transmission, blocking the transmission of viruses and other properties, and designed test methods and procedures for the characteristics of medical emergency work.
[Eye protection products]
The production of eye protection products in China mainly adopts the mandatory national standard GB 14866-2006 “Technical requirements for personal eye protection”. The standard specifies the optical, impact resistance, heat resistance, corrosion resistance, irritant gas protection and other technical performance requirements of personal eye protection and the corresponding test methods, applicable to all kinds of personal eye protection other than nuclear radiation, X-ray, laser, ultraviolet, infrared and other radiation. Depending on the shape of the protective gear, it can be divided into glasses, eye masks and face masks, and the lenses are divided into organic and inorganic lenses. Eye protection shall have the function of providing protection and protection against persons and combinations of injuries such as 1) impacts of varying intensity, 2) visible light radiation, 3) splashes of molten metal, 4) liquid droplets and splashes, 5) dust, 6) irritating gases, etc. or these types of injuries.
The U.S. NFPA 1999 states that materials used in eye protection products should be tested for microbial permeability if the portion of the eye covered by the disposable eye protection product is not a single piece of plastic or solid film. This is in addition to the fluid integrity test, vision/fogging test. If fabric is used in the eye protection products, each layer of fabric should also be tested for flammability, the flame spread time should be more than 3.5 seconds.
American Standard ANSI Z87.1-2015, Personal Eye and Facial Protective Equipment for Occupational and Instructional Use, applies to products such as welding protective goggles, goggles, face shields, etc. and specifies the optical requirements, physical properties, minimum lens thickness, impact resistance, and protection against light radiation, liquid droplets and splashes, dust, etc. for eye protective equipment.
[Foot protection products]
China’s standard for protective footwear is GB 21147-2007 “Personal Protective Equipment and Protective Shoes”, which is revised to adopt ISO 20346: 2004 “Personal Protective Equipment and Protective Shoes”, in which sole performance, toe protection, leak resistance, outsole The tear strength, wear resistance, hydrolysis and oil resistance are mandatory requirements.
The NFPA 1999 standard stipulates the anti-skid, puncture resistance, eyelet peel strength, flammability and other performance indicators of emergency shoes. It also requires an overall test, and the insulation layer and joints must pass the liquid and microorganism resistance test.
Summary of relevant standards:
Medical protective clothing Chinese standard GB 19082-2009 Active 医用一次性防护服技术要求 Technical requirements for medical disposable protective clothing
Medical protective clothing Industry Standard YY/T 0689-2008 Active 血液和体液防护装备 防护服材料抗血液传播病原体穿透性能测试 Phi-X174噬菌体试验方法 Blood and body fluid protective equipment Protective clothing materials against bloodborne pathogens penetration Phi-X174 phage test method
Medical protective clothing Industry Standard YY/T 0691-2008 Active 传染性病原体防护装备 医用面罩抗合成血穿透性试验方法(固定体积、水平喷射) Infectious agent protective equipment Medical mask anti-synthetic blood penetration test method (fixed volume, horizontal injection)
Medical protective clothing Industry Standard YY/T 0700-2008 Active 血液和体液防护装备 防护服材料抗血液和体液穿透性能测试 合成血试验方法 Protective equipment for blood and body fluids Tests for the penetration resistance of materials of protective clothing against blood and body fluids Synthetic blood test method
Medical protective clothing Industry Standard YY/T 1425-2016 Active 防护服材料抗注射针穿刺性能试验方法 Test method for protective clothing material resistance to injection needle puncture
Medical protective clothing Industry Standard YY/T 1498-2016 Active 医用防护服的选用评估指南 Guidelines for the selection and evaluation of medical protective clothing
Medical protective clothing Industry Standard YY/T 1499-2016 Active 医用防护服的液体阻隔性能和分级 Liquid barrier performance and classification of medical protective clothing
Medical protective clothing Industry Standard YY/T 1632-2018 Active 医用防护服材料的阻水性：冲击穿透测试方法 Water resistance of medical protective clothing materials: impact penetration test method
Medical protective clothing American standard ASTM F1670/F1670M-2017a 防护服材料对合成血液渗透的阻力的标准试验方法 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Medical protective clothing American standard ASTM F1671/F1671M-2013 对使用材料的防护服性的试验方法 通过血源性病原体使用披X174噬菌体穿透率的试验系统穿透性 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
Medical protective clothing American standard ASTM F903-2018 Active 防护服用材料耐液体渗透性的试验方法 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
Medical protective clothing British Standard BS EN ISO 13688-2013 Active 防护服 通用要求 Protective clothing. General requirements
Medical protective clothing British Standard BS EN ISO 22612-2005 Active 防传感病病原体的防护服 防干微生物侵入能力的试验方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration
Medical protective clothing British Standard BS ISO 16603-2004 防止接触血液和体液的防护服 测定防护服材料对血液和体液渗透的抵抗力 使用合成血液的测试方法 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
Medical protective clothing German Standard DIN EN ISO 22612-2005 Active 防传感病病原体的防护服 防干微生物侵入能力的试验方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration (ISO22612:2005); German version ENISO22612:2005
Medical protective clothing EU Standard EN 14126-2003+AC-2004 Active 防护服 抗感染防护服的性能要求和试验方法 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents
Medical protective clothing EU Standard EN ISO 22612-2005 Active 防传感病病原体的防护服 防干微生物侵入能力的试验方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration ISO 22612:2005
Medical protective clothing Indian Standard IS 16545-2016 Active 防止接触血液和体液防护服-血传播致病菌对防护服材料渗透性的测定-Phi-X174噬菌体试验方法 Clothing for Protection Against Contact with Blood and Body Fluids - Determination of Resistance of Protective Clothing Materials to Penetration by Blood-Borne Pathagens - Test Method Using Phi-X174 Bacteriophage
Medical protective clothing Indian Standard IS 16546-2016 Active 防止接触血液和体液防护服-血液和体液渗透性测定防护服材料的渗透性-合成血液的试验方法 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
Medical protective clothing International Standards Organization ISO 16603-2004 Active 防血液和体液接触的防护服 防护服材料耐防血液和体液渗入性能的测定 合成血液试验法 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 first edition
Medical protective clothing International Standards Organization ISO 16604-2004 Active 防血液和体液接触的防护服 防护服材料耐血液媒介病原穿透阻力的测定 Phi-X174噬菌体试验方法 Clothing for protection against contact with blood and body fluids determination of resistance of protective clothing materials to penetration by blood-borne pathogens test method using phi-x174 bacteriophage first edition
Medical protective clothing International Standards Organization ISO 22612-2005 Active 防传感病病原体的防护服 防干微生物侵入能力的试验方法 Clothing for protection against infectious agents test method for resistance to dry microbial penetration first edition
Medical protective clothing Japanese Standard JIS T8060-2015 防止接触血液和体液的防护服 测定防护服材料对血液和体液渗透的抵抗力 使用合成血液的测试方法 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
Medical protective clothing Japanese Standard JIS T8061-2015 防止接触血液和体液的防护服 测定防护服材料对血源性病原体渗透的抵抗力 使用Phi-X174噬菌体的测试方法 Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage
Hand protection Chinese standard GB 10213-2006 Active 一次性使用医用橡胶检查手套 Disposable medical rubber examination gloves
Hand protection Chinese standard GB 7543-2006 Active 一次性使用灭菌橡胶外科手套 Disposable sterilized rubber surgical gloves
Hand protection Chinese standard GB 24786-2009 Active 一次性使用聚氯乙烯医用检查手套 Disposable PVC medical examination gloves
Hand protection Chinese standard GB 24788-2009 Active 医用手套表面残余粉末、水抽提蛋白质限量 Limits of residual powder and protein extracted from water on the surface of medical gloves
Hand protection Chinese standard GB/T 21869-2008 Active 医用手套表面残余粉末的测定 Determination of residual powder on the surface of medical gloves
Hand protection Industry Standard YY/T 0616.1-2016 Active 一次性使用医用手套 第1部分：生物学评价要求与试验 Disposable medical gloves Part 1: Biological evaluation requirements and tests
Hand protection Industry Standard YY/T 0616.2-2016 Active 一次性使用医用手套 第2部分：测定货架寿命的要求和试验 Disposable medical gloves Part 2: Requirements and tests for determining shelf life
Hand protection Industry Standard YY/T 0616.3-2018 Active 一次性使用医用手套 第3部分：用仓贮中的成品手套确定实际时间失效日期的方法 Disposable medical gloves Part 3: The method of determining the actual date of expiration using the finished gloves in storage
Hand protection Industry Standard YY/T 0616.4-2018 Active 一次性使用医用手套 第4部分：抗穿刺试验方法 Disposable medical gloves Part 4: Test methods for puncture resistance
Hand protection Industry Standard YY/T 0616.5-2019 unimplemented 一次性使用医用手套 第5部分：抗化学品渗透 持续接触试验方法 Disposable medical gloves Part 5: Resistance to chemical penetration Continual contact test method
Hand protection Brazilian Standard ABNT NBR ISO 11193-1-2009/Amd 1-2015 Active 一次性医用检验手套 第1部分：用胶乳或胶水制成的手套规范 Disposable medical examination gloves Part 1: Specification for gloves made of latex or glue
Hand protection Brazilian Standard ABNT NBR ISO 11193-1-2015 Active 一次性医用检验手套 Disposable medical examination gloves
Hand protection Brazilian Standard ABNT NBR ISO 11193-2-2013 Active 一次性医用检查手套 第2部分：聚氯乙烯制成的手套规范 Disposable medical examination gloves Part 2: Specification for gloves made of polyvinyl chloride
Hand protection American standard ASTM D7160-2016 Active 医用手套有效期测定规程 Standard Practice for Determination of Expiration Dating for Medical Gloves
Hand protection British Standard BS EN 455-2-2015 Active 一次性医用手套 第2部分:物理特性用要求和试验 Disposable medical gloves. Part 2: Requirements and tests for physical properties
Hand protection British Standard BS EN 455-3-2015 Active 一次性医用手套 第3部分:生物评定要求和试验 Disposable medical gloves Part 3: Biological assessment requirements and tests
Hand protection British Standard BS EN ISO 21171-2006 Active 医用手套 可去除表面粉末的测定 Determination of removable powder on medical gloves
Hand protection British Standard BS ISO 12243-2003+A1-2012 Active 医用天然胶乳手套 用改良的半细胞法测定水可萃取蛋白质 Natural rubber latex gloves for medical use
Hand protection German Standard DIN EN 455-1-2001 Active 一次性医用手套.第1部分:密封性要求和检验 Medical gloves for single use. Part1: Requirements and testing for freedom from holes; German version EN455-1:2000
Hand protection German Standard DIN EN 455-2-2015 Active 一次性使用医用手套 第2部分：物理性能的要求和测试;德文版EN455-2：2015 Medical gloves for single use. Part2: Requirements and testing for physical properties; German version EN455-2:2015
Hand protection German Standard DIN EN 455-3-2015 Active 一次性使用医用手套 第3部分：生物评估的要求和测试;德文版EN455-3：2015 Medical gloves for single use. Part3: Requirements and testing for biological evaluation; German version EN455-3:2015
Hand protection German Standard DIN EN 455-4-2009 Active 一次性使用医用手套 第4部分：保质期确定的要求和测试; Medical gloves for single use. Part4: Requirements and testing for shelf life determination; German version EN455-4:2009
Hand protection German Standard DIN EN ISO 21171-2006 Active 医用手套 可去除表面粉末的测定（ISO21171：2006）; 德文版ENISO21171：2006 Medical gloves. Determination of removable surface powder (ISO21171:2006); German version ENISO21171:2006
Hand protection EU Standard CEN/TR 16953-2017 Active 一次性医用手套 选用指南 Selection Guide for Disposable Medical Gloves
Hand protection EU Standard EN 455-1-2000 Active 一次性医用手套.第1部分:密封性要求和检验 Medical Gloves for Single Use. Part 1:Requirements and Testing for Freedom from Holes Supersedes EN 455-1:1993
Hand protection EU Standard EN 455-3-2015 Active 一次性医用手套 第3部分:生物评定要求和试验 Medical gloves for single use. Part 3:Requirements and testing for biological evaluation
Hand protection EU Standard EN ISO 21171-2006 Active 医用手套 可去除表面粉末的测定 Medical gloves Determination of removable surface powder ISO 21171:2006
Hand protection Russian Standard GOST 33070-2014 Active 医用手套 残留粉化剂的测定方法 Medical gloves. Method for determination of residual powdering agent
Hand protection Russian Standard GOST 33076-2014 Active 医用手套 密封性的测定方法 Medical gloves. Method for determination of leak tightness
Hand protection Russian Standard GOST EN 455-1-2014 Active 一次性医用手套 第1部分：气密性的测定方法 Medical gloves for single use. Part 1. Method for determination of tightness
Hand protection Russian Standard GOST EN 455-2-2014 Active 一次性医用手套 第2部分：物理机械性能测定方法 Medical gloves for single use. Part 2. Method for determination of physical-mechanical properties
Hand protection Russian Standard GOST R 52239-2004 Active 一次性使用医用检查手套 第1部分从乳胶或橡胶溶解中制成的手套的规格 Single-use medical examination gloves. Part 1. Specification for gloves made from rubber latex or rubber solution
Hand protection Russian Standard GOST R 57402-2017 Active 医用手套 过期时间的测定 Medical Gloves. Determination Of Expiration Dating
Hand protection Russian Standard GOST R 57404-2017 Active 医用手套 质量评估指南 Medical Gloves. Quality Assessment Guide
Hand protection International Standards Organization ISO 11193-1-2008 Active 一次性医用检查手套 第1部分:由橡胶乳液或橡胶溶液制成手套的规范 Single-use medical examination gloves. Part 1:Specification for gloves made from rubber latex or rubber solution
Hand protection International Standards Organization ISO 11193-2-2006 Active 一次性医用检查手套 第2部分:由聚氯乙烯制成手套的规范 Single-use medical examination gloves. Part 2:Specification for gloves made from poly (vinyl chloride)
Hand protection International Standards Organization ISO 12243-2003 Active 医用天然胶乳手套 用改性格雷法测量可水萃取的蛋白质 Medical gloves made from natural rubber latex determination of water-extractable protein using the modified lowry method first edition
Hand protection International Standards Organization ISO 21171-2006 Active 医用手套 可去除表面粉末的测定 Medical gloves determination of removable surface powder first edition
Hand protection South African Standard SANS 11193-1-2010 Active 一次性使用医用检查手套 第1部分：橡胶胶乳或橡胶溶液制成的手套规范 Single-Use Medical Examination Gloves Part 1: Specification For Gloves Made From Rubber Latex Or Rubber Solution
Hand protection South African Standard SANS 15190-2016 Active 医用手套 安全要求 Medical laboratories - Requirements for safety
Head, face, and foot protection Chinese standard GB 14866-2006 个人用眼护具技术要求 Technical requirements for personal eye protectors
Head, face, and foot protection Industry Standard YY/T 1642-2019 unimplemented 一次性使用医用防护帽 Disposable medical protective cap
Head, face, and foot protection Industry Standard YY/T 1633-2019 unimplemented 一次性使用医用防护鞋套 Disposable medical protective shoe cover
Head, face, and foot protection American standard ANSI/ISEA Z87.1-2015 个人眼睛和面部保护设备 Personal eye and face protection equipment
Head, face, and foot protection International Standards Organization ISO 22609-2004 Active 防传感病病原体的防护服 医用面罩 防人造血渗透性能的试验方法 Clothing for protection against infectious agents medical face masks test method for resistance against penetration by synthetic blood (fixed volume,horizontally projected) first edition
Head, face, and foot protection Japanese Standard JIS T8062-2010 Active 感染性物质的防护服 面具 人工血液的渗透抵抗力测试(定量 水平喷出法) Clothing for protection against inflectious agents. Face masks. Test method for resisitance against penetration by synthetic blood (fixed volume,horizontally projeted)
Head, face, and foot protection Japanese Standard JIS T8150-2006 Active 呼吸防护器具的选择、使用及保管办法 Guidance for selection, use and maintenance of respiratory protective devices
Head, face, and foot protection Japanese Standard JIS T8159-2006 Active 呼吸防护面具漏泄率试验方法 Leakage rate testing method for respiratory protective devices
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