Project Description

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:

Product CategoryStandard categoryStandardStatusChinese nameStandard English name
Medical protective clothingChinese standardGB 19082-2009Active医用一次性防护服技术要求Technical requirements for medical disposable protective clothing
Medical protective clothingIndustry StandardYY/T 0689-2008Active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 clothingIndustry StandardYY/T 0691-2008Active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 clothingIndustry StandardYY/T 0700-2008Active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 clothingIndustry StandardYY/T 1425-2016Active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 clothingIndustry StandardYY/T 1498-2016Active医用防护服的选用评估指南Guidelines for the selection and evaluation of medical protective clothing
Medical protective clothingIndustry StandardYY/T 1499-2016Active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 clothingIndustry StandardYY/T 1632-2018Active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 clothingAmerican standardASTM 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 clothingAmerican standardASTM 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 clothingAmerican standardASTM F903-2018Active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 clothingBritish StandardBS EN ISO 13688-2013Active防护服 通用要求Protective clothing.   General   requirements
Medical protective clothingBritish StandardBS EN ISO 22612-2005Active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 clothingBritish StandardBS 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 clothingGerman StandardDIN EN ISO 22612-2005Active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 clothingEU StandardEN 14126-2003+AC-2004Active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 clothingEU StandardEN ISO 22612-2005Active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 clothingIndian StandardIS 16545-2016Active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 clothingIndian StandardIS 16546-2016Active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 clothingInternational Standards OrganizationISO 16603-2004Active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 clothingInternational Standards OrganizationISO 16604-2004Active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 clothingInternational Standards OrganizationISO 22612-2005Active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 clothingJapanese StandardJIS 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 clothingJapanese StandardJIS 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 protectionChinese standardGB 10213-2006Active一次性使用医用橡胶检查手套Disposable medical rubber examination gloves
Hand protectionChinese standardGB 7543-2006Active一次性使用灭菌橡胶外科手套Disposable sterilized rubber surgical gloves
Hand protectionChinese standardGB 24786-2009Active一次性使用聚氯乙烯医用检查手套Disposable PVC medical examination gloves
Hand protectionChinese standardGB 24788-2009Active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 protectionChinese standardGB/T 21869-2008Active医用手套表面残余粉末的测定Determination of residual powder on the surface of medical gloves
Hand protectionIndustry StandardYY/T 0616.1-2016Active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 protectionIndustry StandardYY/T 0616.2-2016Active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 protectionIndustry StandardYY/T 0616.3-2018Active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 protectionIndustry StandardYY/T 0616.4-2018Active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 protectionIndustry StandardYY/T 0616.5-2019unimplemented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 protectionBrazilian StandardABNT NBR ISO   11193-1-2009/Amd   1-2015Active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 protectionBrazilian StandardABNT NBR ISO   11193-1-2015Active一次性医用检验手套Disposable medical examination gloves
Hand protectionBrazilian StandardABNT NBR ISO   11193-2-2013Active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 protectionAmerican standardASTM D7160-2016Active医用手套有效期测定规程Standard Practice for     Determination of Expiration Dating for Medical Gloves
Hand protectionBritish StandardBS EN 455-2-2015Active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 protectionBritish StandardBS EN 455-3-2015Active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 protectionBritish StandardBS EN ISO 21171-2006Active医用手套 可去除表面粉末的测定Determination of removable powder on medical gloves
Hand protectionBritish StandardBS ISO   12243-2003+A1-2012Active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 protectionGerman StandardDIN EN 455-1-2001Active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 protectionGerman StandardDIN EN 455-2-2015Active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EN455-2:2015Medical gloves for   single use.   Part2: Requirements and testing for physical properties; German     version EN455-2:2015
Hand protectionGerman StandardDIN EN 455-3-2015Active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EN455-3:2015Medical gloves for   single use.   Part3: Requirements and testing for biological evaluation; German     version EN455-3:2015
Hand protectionGerman StandardDIN EN 455-4-2009Active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 protectionGerman StandardDIN EN ISO 21171-2006Active医用手套 可去除表面粉末的测定(ISO21171:2006); 德文版ENISO21171:2006Medical gloves.   Determination   of removable surface powder (ISO21171:2006); German version     ENISO21171:2006
Hand protectionEU StandardCEN/TR 16953-2017Active一次性医用手套 选用指南Selection Guide for Disposable Medical Gloves
Hand protectionEU StandardEN 455-1-2000Active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 protectionEU StandardEN 455-3-2015Active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 protectionEU StandardEN ISO 21171-2006Active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 protectionRussian StandardGOST 33070-2014Active医用手套 残留粉化剂的测定方法Medical gloves. Method   for   determination of residual powdering agent
Hand protectionRussian StandardGOST 33076-2014Active医用手套 密封性的测定方法Medical gloves. Method   for   determination of leak tightness
Hand protectionRussian StandardGOST EN 455-1-2014Active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 protectionRussian StandardGOST EN 455-2-2014Active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 protectionRussian StandardGOST R 52239-2004Active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 protectionRussian StandardGOST R 57402-2017Active医用手套 过期时间的测定Medical Gloves.   Determination   Of Expiration Dating
Hand protectionRussian StandardGOST R 57404-2017Active医用手套 质量评估指南Medical Gloves. Quality     Assessment Guide
Hand protectionInternational Standards OrganizationISO 11193-1-2008Active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 protectionInternational Standards OrganizationISO 11193-2-2006Active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 protectionInternational Standards OrganizationISO 12243-2003Active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 protectionInternational Standards OrganizationISO 21171-2006Active医用手套 可去除表面粉末的测定Medical gloves   determination of   removable surface powder first edition
Hand protectionSouth African StandardSANS 11193-1-2010Active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 protectionSouth African StandardSANS 15190-2016Active医用手套 安全要求Medical laboratories -     Requirements for safety
Head, face, and foot protectionChinese standardGB 14866-2006个人用眼护具技术要求Technical requirements for personal eye protectors
Head, face, and foot protectionIndustry StandardYY/T 1642-2019unimplemented一次性使用医用防护帽Disposable medical protective cap
Head, face, and foot protectionIndustry StandardYY/T 1633-2019unimplemented一次性使用医用防护鞋套Disposable medical protective shoe cover
Head, face, and foot protectionAmerican standardANSI/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 protectionInternational Standards OrganizationISO 22609-2004Active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 protectionJapanese StandardJIS T8062-2010Active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 protectionJapanese StandardJIS T8150-2006Active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 protectionJapanese StandardJIS T8159-2006Active呼吸防护面具漏泄率试验方法Leakage rate testing   method for   respiratory protective devices