中国与欧盟个体防护装备标准指标比对情况Comparison of Personal Protective Equipment Standards
中欧标准对比 医用防护服标准比对情英文
Annex4Comparison of Medical Protective ClothingStandardsThe result of comparison between China's mandatory national standard GB19082-2009technical requirements for disposable protective clothing for medical use and the EU standard(EN14126) is as follows.This result is summarized through the materials of standard comparison provided by Medical Device Standard Management Center of China Medical Products Administration, Science and Technology Development Department of China National Textile Industry Federation,National Technical Committee for Personal Protective Equipment Standardization and other relevant parties.For scope of application：EN14126applies to reusable anti-virus protective clothing.GB19082applies to medical disposable protective clothing for medical personnel who come into contact with potentially infectious patients'blood,body fluids,secretions and airborne particles to provide barrier and protection.For physical properties of fabric：EN14126refers to EN14325,Chemical Protective Clothing-Chemical Protective Clothing Materials,Seams,Joints and the Test Method and Properties Classification of Components.EN14325 requires that protective clothing should be tested and classified according to the fabric test methods and fabric performance classification system determined by the standard.GB19082specifies two indexes such as elongation at break and fracture strength.Other indexes such as wear resistance,flexural resistance,flexural resistance(-30℃)and tear are not specified.For barrier properties of fabric:EN14126mainly refers to international standard such as ISO16603, ISO16604,ISO26610,ISO26611and ISO26612.EU standard specifies the classification requirements in five aspects including anti-synthetic blood penetration,anti-blood-borne pathogen (Phi-X174)bacteriophage contaminated liquid pressure penetration test,anti-wet microbial penetration test,anti-microbial aerosol test, and anti-dry microbial test.GB19082mainly specifies the requirements of the water resistance test,water testing,particle filtration efficiency and moisture permeability.For overall clothing performance:EN14126mainly specifies three indicators,namely,overall clothing performance test,joint strength and skin irritation,among which theoverall clothing performance refers to relevant international standards and EU standards such as EN466.They are divided into protective suits against liquid aerosol and solid particles,liquid dense protective suits(Type3),spray dense protective suits(Type4),protective suits against solid particles(Type5),and protective suits against slight chemical liquid splash(Type6).GB19082specifies six indicators,including requirements for microbial indicators,sterilization requirements,residual ethylene oxide,antistatic property,electrostatic attenuation and skin irritation.Comparison of key requirements from two standards is listed in table 4-1.Table 4-1Comparison of Key Technical Requirements from EN 14126:2003and GB 19082-2009Standard Number GB 19082-2009EN 14126:2003Standard NameTechnical Requirements for Disposable Protective Clothing for Medical UseProtective Clothing -Performance,Requirements and Test Methods for Anti-virus Protective ClothingScopeThe standard standardizes the requirements for disposable protective clothing for medical use.This standard is applicable to medical disposable protective clothing for medical personnel who come into contact with potentially infectious patients'blood,body fluids,secretions and airborne particles to provide barrier and protection.Applications:medical disposable protective clothingThe standard standardizes the requirements and test methods for reusable,limited-use anti-virus protective clothing.The standard does not apply to protective clothing worn by first-line surgical personnel or surgical orders placed on the patient's body to prevent cross-contamination during surgical intervention.Applications:Anti-infective-substance protective clothingTechnical TermsIndex Requirements Test MethodsIndex Requirements Test MethodsPhysical Propertiesof FabricAbrasive Resistance NoneMechanical and flammability requirements:materials shall be tested and classified in accordance with the test methods and performance classification system standardized under the relevant provisions of pr EN 14325.Flexing Resistance None FlexingResistance at-30℃（Optional ）NoneTearResistance NoneElongation at Break Key parts should not be less than 15%GB/T 3923.1-1997Fracture StrengthKey parts should not be less than 45NGB/T 3923.1-1997BarrierImpermeability The hydrostatic pressure GBT 4744-1997NoneProperties of Fabric Test of key parts should be≥1.67kpaWater Test≥Level3GBT4745-1997None ParticleFiltrationEfficiencyThe filtration efficiencyof Nacl at key parts andjoints should be no lessthan70%Article5.7ofGB19082-2009NoneMoistureTransmission≥2500g/(m2·d)Method A ofGB/T12704-1991NoneResistance toSyntheticBloodPenetrationLevel1（0kPa）Level2（1.75kPa）Level3（3.5kPa）Level4（7kPa）Level5（14kPa）Level6（20kPa）Should not≤Level2Annex A toGB19082-2009Level1（0kPa）Level2（1.75kPa）Level3（3.5kPa）Level4（7kPa）Level5（14kPa）Level6（20kPa）Classifivation according toactual test results.ISO16603Pressurepenetration testofcontaminatedliquid againstblood-bornepathogen(phi-x174)bacteriophageNoneLevel1（0kPa）Level2（1.75kPa）Level3（3.5kPa）Level4（7kPa）Level5（14kPa）Level6（20kPa）Classification according toactual test results.ISO16604Resistance toMoistureMicrobePenetrationNoneLevel1（≤15min）Level2（15<t≤30min）Level3（30<t≤45min）Level4（45<t≤60min）ISO26610Level 5（60<t≤75min ）Level 6（t>75min ）T is the breakthrough timeAnti-microbial Aerosol TestNoneLevel 1（1<log≤3）Level 2（3<log≤5）Level 3（log>5）Log is penetrationISO 26611Anti-dry Microbe TestNoneLevel 1（2<log cfu ≤3）Level 1（1<log cfu ≤2）Level 3（log cfu ≤1）Log cfu is the penetration indexISO 26612Overall Clothing PerformanceOverall Clothing Performance TestNoneSpecific requirements refer to other EN standards:——Type 1EN 943-1（EN943-2for emergency team (ET)"airtight"chemical protective clothing ），——Type 3EN 466——Type 4EN 465，——Type 5ISO 13982-1，——Type 6EN 13034——Partial body protection EN 467Seam Strength NoneEN 14325Microbiologica l Index Requirements There are requirements for bacterial colony detection Annex B to GB 15979-2002NoneSterilization RequirementsSterilized and non-sterilized.If sterilized,the words "sterile"shall be marked on the package NoneResidualShould not exceedArticle 5.13ofNoneEthylene Oxide 10μg/g GB19082-2009Skin Irritation The primary stimulusscore should not exceed1Article5.11ofGB19082-2009Article4.3of EN14126requires that materials and designsused shall not cause skin irritation or adverse health effects.Antistatic Property The electric quantity ofprotective clothingshould not exceed0.6μC/pieceArticle7.2ofGB/T12703-1991NoneStatic Decay The static decay time ofprotective clothingshould not exceed0.5s.Article5.10ofGB19082-2009NoneNote:The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.。
中国美国和欧盟的医用防护服标准及指标对比分析
中国美国和欧盟的医用防护服标准及指标对比分析自2020年4月10日起，对11类、19种海关商品编号项下的医疗物资实施出口商品检验。
海关实验室对出口医疗物资的检测，将按照以下标准进行：进口国（地区）有质量安全标准要求的，依据进口国（地区）质量安全标准进行检测；进口国（地区）无质量安全标准要求的，按照我国质量安全标准进行检测。
下面，来一起了解中国、美国、欧盟对于医用防护服各自的执行标准以及相关认证认可要求。
中国医用防护服执行国家标准GB 19082-2009《医用一次性防护服技术要求》，该标准为强制性，针对医用一次性非织造防护服，没有对可重复使用的防护服作出规定。
美国的医用防护服标准是由NFPA(美国车家防火协会)制定的NFPA1999，适用于医疗急救时美国医疗器具开发协会组织制定的AAMIPB-70，适用于评价卫生用防护服装的阻隔性能。
欧盟颁布了EN14126-2003防护服防病毒防护服的性能要求和试验方法，该标准主要关注点为防护服的耐血液、体液和病毒的穿透性。
1中国国内基于风险通常把医疗器械分成三类：第一，风险低的和基本没有风险的属于一类，在地市局药品监管部门机构备案。
第二，中等风险的医疗器械由省一级药品监管部门注册审批。
第三，高风险的医疗器械属于三类，由国家局直接负责组织审批。
医用防护服属于二类医疗器械，由省一级药品监管部门实施注册管理2美国美国食品与药物管理局（FDA）根据风险等级将医疗器械产品分为三个等级进行管理，一级指普通产品，二级指通过特殊控制来保证其安全性和有效性的产品，三级指一般用来支持人体生命，防止人体健康受损，具有治病、致残的潜在不合理风险的产品。
美国医用防护服可分为非手术防护服和手术用防护服两类。
非手术防护服属于I类医疗器械，免于上市前登记，直接进行机构注册。
而手术用防护服属于II类医疗器械，需要进行上市前登记，即需要申请FDA 510K。
II类产品上市前要通告，基本流程如下（1）产品测试（性能测试、化学测试）（2）准备510K文件（3）提交FDA评审（4）FDA发510K批准（5）完成工厂注册和机器列名（6）产品出口3欧盟欧盟经济区市场涉及到安全、卫生、环境保护和消费者保护的商品（如电子、机械、医疗器械、玩具、个人防护设备、通讯、承压设备等）已经被强制性地列入“必须携带CE标记，否则不准进入欧盟市场流通”之列。
口罩标准中俄标准比对分析情况
进行测试，KP 系列采用油性颗粒物进行测试，欧盟同时采用油
性和非油性颗粒物进行测试；我国民用防护口罩标准 GB/T 32610 与欧盟标准、俄罗斯标准指标相当，均同时采用油性和非油性颗
粒物进行测试，但测试流量低。详见表 3。
在呼吸阻力方面，我国标准 GB 2626、GB/T 32610 指标比欧 盟标准和俄罗斯标准指标高，测试方法等同。详见表 4。
抗合成血
微生物
2 ml 合成血液 16kPa 下不穿透
细菌菌落≤100cfu/g；大肠菌群、绿脓杆菌、金黄 色葡萄球菌、溶血性链球菌和真菌不得检出。
——
细菌菌落≤100cfu/g；大肠菌群、绿脓杆菌、金黄 色葡萄球菌、溶血性链球菌和真菌不得检。
细菌菌落总数≤200 cfu/g；真菌总数≤100cfu/g； 2 ml 合成血液 10.7kPa 下不穿透 大肠菌群、绿脓杆菌、金黄色葡萄球菌、溶血性
术要求》，工业防护口罩标准为 GB 2626-2019《呼吸防护 自吸过
滤式防颗粒物呼吸器》，民用防护口罩标准为 GB/T 32610-2016《日 常防护型口罩技术规范》。欧盟标准为 EN 149:2001+A1: 2009《呼
吸防护装置 可防护微粒的过滤式半面罩 要求、测试和标记》，
俄罗斯标准为 GOST 12.4.294-2015《职业安全标准体系 呼吸保护 装置 面罩 一般规范》。经检索，没有发现俄罗斯制定了医用防
针对职业用化学品防护服装，收集汇总了中俄职业用防护服 标准 9 项。由于化学防护服指标体系较为复杂，为便于比对分析， 将技术指标分为物理机械性能指标、面料阻隔性能指标和服装整 体阻隔性能指标三类。具体比对分析情况如下。
—8—
一、物理机械性能指标比对分析(见表 1-表 4)
医用一次性防护服欧盟标准EN14126-2003和我国标准GB19082-2009的主要技术要求对比表
医用一次性防护服欧盟标准EN14126-2003和我国标准GB19082-2009的主要技术要求对比表
标准编号GB 19082-2009 EN 14126-2003
标准名称医用一次性防护服技术要求防护服防传病毒防护服的性能要求和试验方法
适用范围本标准规定了医用一次性防护服的要求。
本标准
适用于医务人员在工作中接触具有潜在感染性的
患者血液、体液、分泌物、空气中的颗粒物等提
供阻隔、防护作业的医用一次性防护服。
适用产品：医用一次性防护服本标准规定了可重复使用的、有限使用的防传病毒防护服的要求和试验方法。
本标准不适用于手术一线人员所穿戴的防护服或者为防止手术干预期间交叉污染而放置在病人身体上的手术单。
适用产品：抗感染性物质防护服
技术条款指标要求测试方法指标要求测试方法
面料物理性能耐磨性无机械和易燃性要求：材料应该根据 pr EN 14325 相关条款
制定的测试方法和性能分类系统进行测试和分类。
耐屈挠性无
耐屈挠性（-30℃）
（可选）
无
撕裂无
断裂伸长率关键部位应不小于15 GB/T 3923.1-1997
断裂强度关键部位应不小于
45N
GB/T 3923.1-1997
面料阻隔性抗渗水性测试关键部位静水压应≥
1.67kPa
GBT 4744-1997 无
沾水性测试≥3 级GBT 4745-1997 无颗粒过滤效率关键部位及接缝处对
非油性颗粒物过滤效
率应不小于 70
GB 19082-2009 第5.7 条无透湿量≥2500g/(m2·d) GB/T 12704-1991 的方法无。
个人用眼护具中国标准与欧洲等国外标准比对分析(英文版)
Annex6Comparison of Personal Eye ProtectorStandardsPersonal eye protectors include various forms and functions of eye and face protection equipment used by personnel in various environments and occupations.The product form and structure mainly include glasses,eye goggles,face shield,etc.In the context of epidemic prevention and control,the product structure forms used are mainly eye goggles and face shields.In China and in Europe,the technical requirements for personal eye protection are mainly composed of two categories of requirements:basic requirements and optional rquirements.The basic requirements mainly include:visible light transmittance and impact resistance.Optional items include high-speed particle impact resistance,etc.Among them,the chemical droplet protection performanceis mainly related to the epidemic control,which is called protection against droplets and splashes in the European standard. For visible light transmittance,the visible light transmittance of GB 14866-2006for colorless and transparent lenses should be>0.89,EN 166requires for lenses that only provide mechanical or chemicalprotection,the visible transmittance>0.744.For impact resistance,GB14866-2006requires that lenses and eye protector can withstand the impact of steel balls with a diameter of 22mm and45g falling from a height of1.3m without being damaged. For protection against droplets and splashes of liquids:GB 14866-2006and EN166-2001both require the use of a liquid spray for coloration testing,which requires no staining in the center of the covered area of the eye protector.The EN standard only tests eye goggles,and the coverage of the face shield is evaluated. Comparison of key requirements from two standards is listed in table 6-1.Table6-1Comparison of Key Requirements of Personal Eye Protection between Two StandardsCountry China European UnionProduct Personal eye-protector:eyegoggles,face shields Personal eye-protector:eye goggles, face shieldsStandard GB14866-2006The specificationsfor personal eye-protectorsEN166:2001Personaleye-protection—SpecificationsScope All kinds of personal eyeprotectors except those providingprotection against nuclearradiation,X-ray,laser,ultraviolet,infrared and other radiation.Various types of personal eyeprotection,including eye protectionthat provides mechanical,optical,and droplet protection.Visible light transmittan ce for colorless and transparentlenses:>0.89for lenses that only providemechanical or chemical protection:>0.744Impact resistance Requires that lenses and eyeprotector can withstand the impactof steel balls with a diameter of22mm and45g falling from aheight of1.3m without beingdamaged.Requires that lenses and eyeprotector can withstand the impactof steel balls with a diameter of22mm and45g falling from a heightof1.3m without being damaged.Protection against droplets and splashes of liquids Require the use of a liquid sprayfor coloration testing,whichrequires no staining in the centerof the covered area of the eyeprotector.The GB standard testsboth eye goggles and the faceshields.Require the use of a liquid spray forcoloration testing,which requiresno staining in the center of thecovered area of the eye protector.The EN standard only tests eyegoggles,and the coverage of theface shield is evaluated.Note:The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.。
中国与欧盟个体防护口罩标准指标比对情况Comparison of Respiratory Protective Equipment Standards
中国与欧盟个体防护口罩标准指标比对情况Comparison of Respiratory Protective Equipment StandardsRespiratory protective equipment—non-powered air-purifying particle respirator is mainly used in all kinds of places where aerosol particles exist, including all kinds of occupational places and daily places. The main function of the mask is to block liquid and solid particles into the wearer's respiratory tract through the filter material of the mask and the tightness design of the mask body. Key core indicators mainly include filtration efficiency, leakage rate, respiratory resistance, etc. Non-powered air-purifying particle respirator shall meet the standard GB 2626 in China, and meet the standard EN149 in European Union.For penetration of filter material/ filtration efficiency:In GB 2626-2006, KN classes test Nacl only, KP classes test Paraffin oil only. Requirements of filtration efficiency: KN90≥90%, KN95≥ 95%, KN100 ≥99.97%; KP90 ≥90%, KP95 ≥95%, KP100 ≥99.97%.In EN 149:2001+A1:2009, both Nacl and Parrafin oil tests are required. Requirements of filtration efficiency: FFP1≥80%, FFP2≥ 94%, FFP3 ≥ 99%. In general, the penetration/ filtration efficiency requirements are similar in both standards.For Inward leakage:Both standards are setting out same level of requirements for the Total Inward Leakage (TIL). In both GB 2626-2006 and EN 149:2001+A1:2009 at least 46 out of 50 individual TIL results and at least 8 out of 10 individual wearer TIL means are required.The requirements are as follows:KN90/KP90/FFP1: At least 46 out of 50 individual results≤25%, at least 8 out of 10 individual wearer means≤22%;KN95/KP95/FFP2: At least 46 out of 50 individual results≤ 11%, at least 8 out of 10 individual wearer means≤8%;KN100/KP100/FFP3: At least 46 out of 50 individual results≤5%, at least 8 out of 10 individual wearer means≤2%.For breathing resistance:In GB 2626-2006, all classes: Inhalation resistance ≤ 350Pa at continuous flow, 85LPM;all classes: exhalation resistance≤250Pa; at continuous flow, 85LPM.In EN 149:2001+A1:2009: Inhalation resistance, at continuous flow, 95LPM, FFP1 ≤210Pa, FFP2 ≤240Pa, FFP3 ≤300Pa; Exhalation resistance, at continuous flow, 160LPM, all classes: ≤300Pa. Comparison of key requirements from two standards is listed in table 2-1:Table2-1 Comparison of key requirements between two standardsNote: The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.个体防护装备口罩（自吸过滤式防颗粒物呼吸器）标准比对情况个体防护装备口罩（自吸过滤式防颗粒物呼吸器）主要用于各类存在气溶胶颗粒物的场所使用，包括各类职业场所和日常场所。
(2020中国标准与欧洲等国外标准进行了文本比对分析)医用防护服标准比对情况
医用防护服标准比对情况
经汇总国家药品监督管理局医疗器械标准管理中心、中国纺 织工业联合会科技发展部、全国个体防护装备标准化技术委员会 等 相 关 方 面 提 供 的 标 准 比 对 材 料 ， 我 国 强 制 性 国 家 标 准 GB 19082-2009《医用一次性防护服技术要求》和欧盟标准（EN 14126） 的比对情况如下。
两项标准技术指标对比见表 4-1。
表 4-1 欧盟标准 EN 14126:2003 和我国标准 GB 19082-2009 的主要技术要求对比
标准编号
GB 19082-2009
EN 14126:2003
标准名称
医用一次性防护服技术要求
防护服 防传病毒防护服的性能 要求和试验方法
适用范围
本标准规定了医用一次性防护服的要求。本标准 本标准规定了可重复使用的、有限使用的防传病毒防护服
密”化学防护服），
无
——3 型 EN 466 ——4 型 EN 465，
——5 型 ISO 13982-1，
——6 型 EN 13034
服 装 接缝强度 整 微生物指标要求
无 对菌落检出有要求
GB 15979-2002 附录 B
——部分身体保护 EN 467 EN 14325 无
体 灭菌要求
灭菌和非灭菌,如果是
性
灭菌，包装上标识“无
无
能
菌”字样
环氧乙烷残留量 应不超过 10μg/g
GB19082-2009 第 5.13 条
无
皮肤刺激性
原发性刺激记分应不 超过 1
GB19082-2009 第 5.11 条
适用于医务人员在工作中接触具有潜在感染性的 的要求和试验方法。本标准不适用于手术一线人员所穿戴
中欧消防员灭火防护服标准比较
家标准 ， 并且 被认 定 为 消防 灭 火 防 护服 的最 低 限度 标准 。 目前 ， 太地 区一 些 国家 也 陆续 引用 该 标 准 ， 标 准 规 定 亚 该 了消 防 员参 加 灭 火 战 斗 和 普 通救 援 的防 护 服 的 最 低 性 能
在火 灾 现 场 ， 消仿 员 常 处 于火 焰 辐 射 、 温 烟气 环 绕 高 的 环境 ， 对 消 防员 的 人 身 安 全 构 成 了 一 定 的 威 胁 。 消 这 防 灭火 防护 服 是保 护 消防 员 在 灭 火救 援 中免 受 伤 害 的最 主要 、 是 最 有 效 的防 护 装 备 。很 多 国 家 都 发 布 了 灭 火 也 防护 服 的 相关 标 准 ， 以规 范 灭 火 服 的各 种 性 能 技 术 要 用 求 和 测 试 方法 ， 国 采用 公 共 安 全 行业 标 准 ＧＡ Ｏ 消 防 我 １《 员 灭 火 防护 服 》 欧 洲 大 多 数 国家 采 用 欧 盟 标 准 ＥＮ ４ ９ ， ６
设计、 阻燃 、 热 、 耐 隔热 、 静 水 压 及 透 水 蒸 气 、 拉 和 耐 撕 以及 耐 抗
反 光 带 的 可见 性 等 主 要 性 能 的 技 术 要 求 。我 国 标 准 对 灭 火 防 护服 设 计 的规 定 非 常 具体 ， 盟标 准则 是 以 最 终 灭 火 防 护 服 的 欧
《 防员 防护 服 一 消 防员 防 护 服 性 能 要 求 》 这 些 标 准 或 消 ，
要求 ， 不适用于化学 、 生化和具有辐射危险 的事故救援使
用 ， 不 适 用 对 头 、 和脚 的保 护 。 也 手
２ 中 欧灭 火 防 护 服 技 术要 求 比较
Ｇ ０与 Ｅ ６ Ａ１ Ｎ ４ ９分别 对 灭 火 服 防 护 的设 计 、 面料 的 阻燃 、 热 、 热 、 气 性 以 及 可 见 性 等 技 术 要 求 做 了规 耐 隔 透
国内外医用防护服性能指标对比分析
Standard Paterit国内外医用防护服性能指标对比分析张传雄（纺织工业科学技术发展中心，北京，100020）摘要：世界各地的医用防护服的标准体系均是根据本地区特点建立，其性能指标要求也不同。
本文介绍了医用防护服的类型，广义上可分为医用一次性防护服、手术衣和隔离衣，并对不同地区医用防护服的性能指标进行对比分析，各地区性能要求侧重点不同，美国、欧盟地区对医用防护服的分类分级较细，而中国对医用一次性防护服性能指标要求则比较明确和直观。
关键词：医用防护服；性能指标；手术衣；隔离衣中图分类号：TS106.6文献标识码：A文章编号：1007-9515（2021）02-0065-06Comparative Analysia of Performance Indexea ofMedical Pratective Clothing iv Differeri CountriraZHANG Chuanxiong(Textile Industa Science and Technolony Develonmeni Centeo,Beijing,100022,China)Abstract:The standarO system of melical protective clothing all ovco the worlO is estaniisheC accorOina tn the characteostics of the reeion,and Os peOorrmiaca indee01X011,-are also dimerent.This pdper introOuces the tyyes of meCicei protective clothing,whicO are broaniy UiviOeC into meCicei Uisposanie protective clothing,surgicei gowa and isolation gown.The peUormddce indexes of meCicei protective clothing in Umemdt regiods are comparei and analyzeC1The perfounadce001X011,3of veuons reeions are dimerent.The classification of meCicei protective clothing in the UniteC States ani the Eampeca Union is One,while the perfounaace oquiomects On meCiceO Uishosanie protective clothing in China are clecr and01x1000.Key words：meCiceO protective clothing；peOormance indexes；surgiceO gown；isolation gown0引言入了前所未有的大团结，共同对抗此次疫情。
中欧标准对比 个体防护装备标准比对情况 英文
Annex5Comparison of Personal ProtectiveEquipment StandardsProtective clothing is the Personal Protective Equipment worn by all types of personnel to protect against physical,chemical and biological and other external risks.The chemical protective clothing for protection against biological agents is the one most used during the pandemic.The chemical protective clothing standards of China are GB 24539and GB/T29511.The corresponding standards of Europe are EN14126and its cited standards such as EN14325,EN 14605,ISO13982.For example,Type3B chemical protective clothing is the product that meet both the Type3requirement of EN14605and the requirements of EN14605. Comparison of key requirements between Chinese and European standards are listed in Table5-1and Table5-2.Table1Comparison of key requirements betweenEN14605and GB24539-2009Country China European Union Product Chemical protective clothing Chemical protective clothing(Type3、Type4)Standard GB245392009Protective clothing-Performance requirementsof chemical protective clothing EN146052005+A12009 Protective clothing against liquid chemicals—Performance requirements for clothing with liquid-tight(Type3)or spray-tight (Type4)connections,including items providing protection to parts of the body only(Types PB[3]and PB[4])Scope Chemical protective clothing for occupationalpersonnels of various occupation oremergence responses.Chemical protective clothing providing liquid-tight(Type3)or spray tight(Type4),including items providing protection to parts of the body only(Types PB[3]and PB[4]).Types Type3a Type3Type3b Type4None PB[3]and PB[4]（Partial PB[3],PB[4]）Product name3a liquid tight3b spray tight 3liquid tight 4spray tightPhysical property of material Abrasion resistance3a：≥level3（>500cycles）≥level1(>10cycles)（type3same with type4）3b：≥level1(>10cycles)Flex resistance ≥level1（1000cycles）（type3a same withtype3b）≥Level1（1000cycles）（type3same with type4）Flex resistance at -30℃（optional）None≥level1（>100cycles）（Optional）（type3same with type4）Tear resistance ≥level1（>10N）（type3a same withtype3b）≥level1（>10N）（type3same with type4）Tensile strength ≥level1（>30N）（type3a same withtype3b）≥level1（>30N）（type3same with type4）Puncture resistance≥level1（>5N）≥level1（>5N）（type3a same withtype3b）（type3same with type4）High and low temperature resistance 70℃@8h，drop of tensile strength≤30%-40℃@8h，drop of tensile strength≤30%（type3a same with type3b）NoneChemicalresistance of material Permeation ofchemicalType3a：≥level3（60min）（1among15种designatedchemicals）Type3b：≥level1≥level1（10min）（1among15种designated chemicals）（type3same with type4）（10min）（1among15种designated chemicals）Penetration of liquid under pressure Type3a：≥level1（3.5kPa）Type3b：NoneNoneLiquid penetration and repellency Type3a：NoneType3b：≥level1（liquid repellency>80%, penetration index<10%）无Whole-suitperformance Whole-suit test Type3a liquid jet testType3b liquid spray testType3：liquid jet test same withGB-3aType4：liquid spray test same withGB-3bSeam strength ≥level1（>30N）（type3a same withtype3b）≥level1（>30N）（type3same with type4）Table2Key requirements comparison between ISO13982and GB24539-2009、GB/T29511-2013 Country China European UnionProduct Chemical protective clothingagainst solid particles Chemical protective clothing against solid particlesStandard GB245392009Protective clothing-Performancerequirements of chemicalprotective clothing and EN ISO13982-1:2004amd1-2010Protective clothing for use against solid particulates-Part1: Performance requirements for chemicalGB/T29511-2013 Protective clothing.Chemical protective clothing against solid particulates protective clothing providing protection to the full body against airborne solid particulates(type5clothing)(Incorporates Amendment A1:2010)Scope Chemical protective clothing foroccupational personnels ofvarious occupation or emergenceresponses-solid particles.Chemical protective clothing providing protection to the full body against airborne solid particulates(type5clothing)Types Type4Type5Physical property of material Abrasionresistance3a：≥level3（>500cycles）3b：≥level1(>10cycles)≥level1(>10cycles)（type3same with type4）Flexresistance≥level1（1000cycles）（type3a same with type3b）≥level1（1000cycles）（type3same with type4）Flexresistance at -30℃（optional）None≥level1（>100cycles）（optional）（type3same with type4）Tear resistance ≥level1（>10N）（type3a same with type3b）≥level1（>10N）（type3same with type4）Tensile strength ≥level1（>30N）（type3a same with type3b）≥level1（>30N）（type3same with type4）Puncture resistance ≥level1（>5N）（type3a same with type3b）≥level1（>5N）（type3same with type4）High and low temperature 70℃@8h，drop of tensile strength≤30%-40℃@8h，drop of tensile无resistance strength≤30%（type3a same with type3b）Chemical protective property of material Penetrationof solidparticlesFiltration efficiency of non-oilparticles≥70%无Hydrostaticpressure≥level1(＞1.0kPa)（beforeabrasion）After100cycles of abrasion，drop in hydrostatic pressure≤50%无Whole suit performance Whole suitperformanceInward leakageL jmn,82/90≤30%，L S,8/10≤15%Inward leakageL jmn,82/90≤30%，L S,8/10≤15%Seam≥level1（＞30N）≥level1（＞30N）strengthNote:The comparison provided is only a text comparison of technical information,not as a legal basis for the foreign party to choose Chinese products.。
中欧标准对比个人用眼护具标准比对情况英文
Annex6Comparison of Personal Eye ProtectorStandardsPersonal eye protectors include various forms and functions of eye and face protection equipment used by personnel in various environments and occupations.The product form and structure mainly include glasses,eye goggles,face shield,etc.In the context of epidemic prevention and control,the product structure forms used are mainly eye goggles and face shields.In China and in Europe,the technical requirements for personal eye protection are mainly composed of two categories of requirements:basic requirements and optional rquirements.The basic requirements mainly include:visible light transmittance and impact resistance.Optional items include high-speed particle impact resistance,etc.Among them,the chemical droplet protection performanceis mainly related to the epidemic control,which is called protection against droplets and splashes in the European standard. For visible light transmittance,the visible light transmittance of GB 14866-2006for colorless and transparent lenses should be>0.89,EN 166requires for lenses that only provide mechanical or chemicalprotection,the visible transmittance>0.744.For impact resistance,GB14866-2006requires that lenses and eye protector can withstand the impact of steel balls with a diameter of 22mm and45g falling from a height of1.3m without being damaged. For protection against droplets and splashes of liquids:GB 14866-2006and EN166-2001both require the use of a liquid spray for coloration testing,which requires no staining in the center of the covered area of the eye protector.The EN standard only tests eye goggles,and the coverage of the face shield is evaluated. Comparison of key requirements from two standards is listed in table 6-1.Table6-1Comparison of Key Requirements of Personal Eye Protection between Two StandardsCountry China European UnionProduct Personal eye-protector:eyegoggles,face shields Personal eye-protector:eye goggles, face shieldsStandard GB14866-2006The specificationsfor personal eye-protectorsEN166:2001Personaleye-protection—SpecificationsScope All kinds of personal eyeprotectors except those providingprotection against nuclearradiation,X-ray,laser,ultraviolet,infrared and other radiation.Various types of personal eyeprotection,including eye protectionthat provides mechanical,optical,and droplet protection.Visible light transmittan ce for colorless and transparentlenses:>0.89for lenses that only providemechanical or chemical protection:>0.744Impact resistance Requires that lenses and eyeprotector can withstand the impactof steel balls with a diameter of22mm and45g falling from aheight of1.3m without beingdamaged.Requires that lenses and eyeprotector can withstand the impactof steel balls with a diameter of22mm and45g falling from a heightof1.3m without being damaged.Protection against droplets and splashes of liquids Require the use of a liquid sprayfor coloration testing,whichrequires no staining in the centerof the covered area of the eyeprotector.The GB standard testsboth eye goggles and the faceshields.Require the use of a liquid spray forcoloration testing,which requiresno staining in the center of thecovered area of the eye protector.The EN standard only tests eyegoggles,and the coverage of theface shield is evaluated.Note:The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.。
医用防护物品国内标准及国外标准对照表【模板】
GB14866-2006个人用眼护具技术要求
国际标准组织:《IS0 4849-1981个人用眼护具技术要求》
欧盟:《EN166-2001个人用眼护具技术要求》
美国:《ANSI Z87.1职业和教育性个人眼睛和面部保护装置》
日本:《JIS T8147-2016个人护目器》
凡是声称符合国外标准要求的个人用医用隔离面罩可在目前应急阶段可以使用。
医用外科口罩
YY0469-2011医用外科口罩
美国:《 Guidance for Industry and FDA Staff Surgical Masks -Premarket Notification [510(k)] Submissions》
欧洲:《EN14683医用口罩一要求及测试方法》
日本:《JIST8062:2010感染性物质防护服一口罩-人工血液耐渗透性试验方法》
韩国:《 KS K IS0 22609传染性药物隔离防护服医疗用口罩-人工血液(一定量、水平注入)的防渗透测试》
国际标准组织:《IS0 22609:2005传染试剂防护服医疗面罩防止人造血渗透的试验方法》
美国材料学会:《 ASTM F2100-2018医用囗罩用材料性能的标准规范》
对于捐赠的医用防护口罩,应符合美国510K的上市要求，或满足美国《ASTM F2100-2018》中2级、3级屏障,《EN 14683》中typeIIR的要求, 或通过《JIST8062：2010》、 《KS K ISO 22609》、《ISO22609:2005》等抗合成血液穿透的测试要求,在满足上述前提下：(1). 如果物品可以提供境外医疗器械上市证明文件,可以直接发给医疗机构使用；(2)如果无法提供上市证明，应由各地新冠肺炎防控部门到货物现场查验,必要时抽样送检验机构按照《GB 19083 -2010医用防护口罩》检测“4.2鼻夹； 4.3口罩带；4.4过滤效率； 4.6合成血液穿透；4.12密合性”,合格后再发给医疗机构使用；
中欧个体防护装备标准比较研究
中欧个体防护装备标准比较研究
周宏;黄献聪;傅雅惠
【期刊名称】《中国个体防护装备》
【年(卷),期】2014(000)002
【摘要】本文系统地研究整理了中欧个体防护装备标准,分析了中欧标准化工作的现状,对中欧个体防护装备标准进行了比较研究,提出了提升我国个体防护装备标准化工作水平的设想.
【总页数】16页(P26-41)
【作者】周宏;黄献聪;傅雅惠
【作者单位】总后勤部军需装备研究所北京 100082;总后勤部军需装备研究所北京 100082;总后勤部军需装备研究所北京 100082
【正文语种】中文
【相关文献】
1.中欧知识管理标准化比较研究 [J], 何一乐
2.中欧纺织服装术语定义标准比较研究 [J], 张雅莉;吴雄英;丁雪梅
3.中欧个体防护装备标准比较研究 [J], 周宏
4.中欧旅游标准化运作机制比较研究及其对我国的启示 [J], 马震;李树民
5.中欧标准必要专利比较研究与借鉴 [J], 严文斌
因版权原因，仅展示原文概要，查看原文内容请购买。
中国与欧盟个人用眼护具标准指标比对情况Comparison of Personal Eye Protector Standards
中国与欧盟个人用眼护具标准指标比对情况Comparison of Personal Eye Protector StandardsPersonal eye protectors include various forms and functions of eye and face protection equipment used by personnel in various environments and occupations. The product form and structure mainly include glasses, eye goggles, face shield, etc. In the context of epidemic prevention and control, the product structure forms used are mainly eye goggles and face shields. In China and in Europe, the technical requirements for personal eye protection are mainly composed of two categories of requirements: basic requirements and optional rquirements.The basic requirements mainly include: visible light transmittance and impact resistance. Optional items include high-speed particle impact resistance, etc. Among them, the chemical droplet protection performanceis mainly related to the epidemic control, which is called protection against droplets and splashes in the European standard.For visible light transmittance, the visible light transmittance of GB 14866-2006 for colorless and transparent lenses should be> 0.89, EN 166 requires for lenses that only provide mechanical or chemicalprotection, the visible transmittance > 0.744.For impact resistance, GB 14866-2006 requires that lenses and eye protector can withstand the impact of steel balls with a diameter of 22mm and 45g falling from a height of 1.3m without being damaged. For protection against droplets and splashes of liquids: GB 14866-2006 and EN 166-2001 both require the use of a liquid spray for coloration testing, which requires no staining in the center of the covered area of the eye protector. The EN standard only tests eye goggles, and the coverage of the face shield is evaluated. Comparison of key requirements from two standards is listed in table 6-1.Table 6-1 Comparison of Key Requirements of Personal EyeProtection between Two StandardsNote: The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.个人用眼护具标准比对情况个人用眼护具包括各类环境、职业的人员使用的各类形式、功能的眼面防护装备。
中国与欧盟个体防护装备标准指标比对情况ComparisonofPersonalProtectiveE
Chemical protective clothing for occupational personnels of various occupation or emergenc eresponses- solid particles.
Chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing)
EN 14605 and GB 24539-2009
Country
China
European Union
Product
Chemical protective clothing
Chemical protective clothing (Type
3、Type 4)
Standard
GB 24539 2009
Scope
Chemical protective clothing for occupational personnels of various occupation or emergence responses.
Chemical protective clothing providing liquid-tight (Type 3) or spray tight (Type 4), including items providing protection to parts of the body only (Types PB [3] and PB [4]).
(type 3 same with type 4)
Highand
70 C @8h , drop of tensile
医用防护服国内标准与国外标准对比
”：非油性颗粒的过滤效 穿透率（log）：
率应不小于70%（氯化钠 3级：log > 5 ;
颗粒穿透 气溶胶或类似固体气溶 2级：3 < log ≤5 ;
-
-
胶，直径750±20nm,颗粒 1级：1 < log ≤3 ;
分布的几何标准偏差：≤ ISO/DIS 22612“抗固体颗粒污染能
1.86；浓度≤200mg/m3） 力试验”：
6型防护服：对应标准prEN13034(最
低等级)
静水压 GB/T4744-2013“静水压试
AATCC127-2003“静水压试验”：
验”：
不低于1.67kPa(17cm -
1级：无规定
-
2级：≥20cm H2O
3级：≥50cm H2O
4级：无规定
Байду номын сангаас
沾水 GB/T4745-2012“沾水试验
AATCC22“冲击穿透试验”
或重复使用）
次性或重复使用）
6个等级
4个等级：
1a,1b,1c,2型防护服：对应标准 EN943-1(EN943-2针对1ET);
等级1(最低等级)
3型防护服：对应标准EN466；
等级2
分级
1个等级
4型防护服：对应标准EN465；
1个等级
等级3
5型防护服：对应标准prEN ISO 13982-1;
等级4
-
1级：≤4.5g
2级：≤1.0g
3级：≤1.0g
4级：无规定
ASTM F1359 “全面液体透 过试验”
-
ASTM F1359 “全面液体透 ASTM F1670-2007
过试验”
(2020中国标准与欧洲等国外标准进行了文本比对分析)个体防护装备标准比对情况
表 5-2 ISO 13982 和 GB 24539-2009、GB/T 29511-2013 主
要技术要求对比
国家
中国
欧盟
品种
固体颗粒物化学防护服
固体颗粒物化学防护服
执行标准
GB 24539 2009 防护服装 化学防护服通用技术要 求/GB/T 29511-2013
ISO 13982-1: 2004 amd1-2010 固 体颗粒防护服 第 1 部分:提供全身 防护的固体颗粒物化学防护服性能
附件 5
个体防护装备标准比对情况
防护服装是各类人员穿着的，防御物理、化学和生物等
外界因素伤害的躯体防护装备。与此次疫情相关的具体防护
服装产品，是具有生物介质防护性能的化学防护服。
我国化学防护服标准需符合 GB 24539 及 GB 29511 标准，
欧盟具有生物介质防护性能的化学防护服需符 EN14126 及其
防护性能 物穿透性 小于 70%
耐静水压
≥1 级(＞1.0kPa)（耐磨测试前） 耐磨测试 100 圈后，静水压下降不 无 大于 50%
服 装 整 体 整 体 服 装 向内泄漏率
向内泄漏率
性能
测试 接缝强度
Ljmn, 82/90≤30%， LS,8/10≤15% ≥1 级（＞30 牛顿）
Ljmn, 82/90≤30%， LS,8/10≤15% ≥1 级（＞30 牛顿）
引用的 EN14325、EN14605（服装整体性能）、ISO 13982（服
装整体性能）等标准。例如，符合 EN 14605 中 3 型的标准，
同时又符合 EN 14126 要求的产品就属于 Type 3B 型。
国家 品种 执行标准
国内外医用防护服标准比较及分析
国内外医用防护服标准比较及分析张建春郝新敏杨元（总后勤部军需装备研究所）“非典”的肆虐，引起了人们对防护用品的重视，针对大批医护人员在工作中被感染，ＷＨＯ与美国ＣＤＣ提倡：为控制强传染性病毒的蔓延，应选择适当的防护装备。
医用防护服要能阻隔微生物、颗粒物质和流体透过，经受消毒处理，耐用、耐磨、抗撕裂、防穿刺、抗纤维应变；不含有毒成分、不起绒、有良好的性价比、符合ＯＳＨＡ规定的舒适性和安全性。
但是目前国内普通医用防护服的质量良莠不齐，不能为医护人员提供有效防护，我们急需一个统一的标准来规范防护品市场。
为此，由国家食品和药品监督管理局等部门参照欧美标准，紧急出台了有关防护服产品的国家强制性标准。
由于各国标准的制定方式、考虑因素以及产品性能、测试手段不同，各标准间存在着较大的差异。
１防护服检测标准１．１国外目前国际上较通用的标准是美国ＮＩＯＳＨ标准和欧盟的ＥＮ标准。
美国的医用防护服标准是由ＮＦＰＡ（美国国家防火协会）制定的“ＮＦＰＡ１９９９＂‘，适用于医疗急救，规定了为人员提供阻隔血液和体液的最低防护标准，把对人体的防护分为头部、身体（除头、手、足部以外的所有部分）、手和足部四种，其产品按这四个功能分为：（１）面部防护品包括防飞沫眼都防护品、戴帽兜的头盔、面具等。
（２）防护衣分为一次性和可重复使用两种，包括分体式和连体式的工作服、病患使用的（３）隔离袋、围裙、套袖等。
（４）一次性急救手套（５）急救鞋欧盟的标准则是由ＣＥＮ（欧洲标准委员会）制定的。
１．２国内我国对防护服、口罩和手套单独制定标准（没有眼部和足部防护品的标准），包括：ＧＢ７５４３—１９９６《橡胶医用手套》、ＧＢ１０２１３—１９９５《一次性使用橡胶检查手套》；ＧＢ１９０８２－－２００３《医用一次性防护服技术要求》防护服由帽子、上衣、裤子组成，可分为连身式结构和分身式结构’’，没有对可重复使用的防护服作出规定：国内外医用防护服标准比较及分析作者：张建春， 郝新敏， 杨元作者单位：总后勤部军需装备研究所本文链接：/Conference_6737028.aspx。
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pressure
Type3a：≥level1
（3.5kPa）
Type 3b：None
None
Liquidpenetrationandrepellency
Type 3a：None
Type3b：≥level1（liquidrepellency>80%, penetrationindex<10%）
无
Whole-suitperformance
Whole-suit test
Type 3a liquid jet test Type 3b liquid spray test
Type 3：liquid jet test same with GB-3a
Type 4：liquid spray test samewith
（60min）（1among 15种designatedchemicals）
Type 3b：≥level1
≥level1（10min）（1 among 15种
designated chemicals）
（type 3 same with type 4）
（10min）（1 among 15
种designatedchemicals）
70℃@8h，dropoftensile strength≤30%
-40℃@8h，dropoftensile strength≤30%
（type3asamewith
type 3b）
None
Chemicalresistancematerial
of
Permeationchemical
of
Type 3a：≥ level 3
Chemical protective clothing providing liquid-tight (Type 3) or spray tight (Type 4), including items providing protection to parts of the
body only (Types PB [3] and PB [4]).
（type3asamewithtype 3b）
≥Level 1（1000 cycles）
（type 3 same with type 4）
Flex resistance at
-30℃（optional）
None
≥level 1（> 100cycles）（Optional）
（type 3 same with type 4）
（type 3 same with type 4）
Puncture resistance
≥level 1（>5N）
≥level 1（>5N）
（type3asamewith
type 3b）
（type 3 same with type 4）
High and temperature resistance
low
Tear resistance
≥level 1（> 10 N）
（type3asamewithtype 3b）
≥level 1（> 10 N）
（type 3 same with type 4）
Tensile strength
≥level 1（>30N）
（type3asamewithtype 3b）
≥level 1（>30N）
The chemical protective clothing standards of China areGB 24539 and GB/T 29511. The corresponding standards of Europe are EN 14126 and its cited standards such as EN 14325, EN 14605, ISO 13982. For example,Type3B chemical protective clothing is the product that meet both theType3 requirement of EN 14605 and the requirements of EN 14605.
of material
Abrasion resistance
3a：≥level 3（>500
cycles）
≥level 1(>10 cycles)
（type 3 same with type 4）
3b：≥level 1(>10 cycles)
Flex resistance
≥level 1（1000 cycles）
Types
Type 3a
Type 3
Type 3b
Type 4
None
PB[3] and PB[4]
（Partial PB [3], PB [4]）
Product name
liquidtight
3b spraytight
3liquidtight
4spraytight
Physical property
Comparison of key requirements between Chinese and European standards are listed inTable5-1 andTable5-2.
Scope
Chemical protective clothing for occupational personnels of various occupation or emergence responses.
中国与欧盟个体防护装备标准指标比对情况Comparison of Personal Protective Equipment Standards
Protective clothing is the Personal Protective Equipment worn by all types of personnel to protect against physical, chemical and biological and other external risks. The chemical protective clothing for protection against biological agents is the one most used during thepandemic.