当前，一场防控新型冠状病毒肺炎的全民阻击战已经打响，全国上下众志成城，共克时艰。本文将口罩、消毒剂、手套、护目镜、防护服等防护产品相关国内外标准进行整理汇编，供参考。篇幅较长，建议收藏。 第一部分 口罩相关国内外标准 国别 标准号 中文题名 英文题名 中国 GB 2626-2006 呼吸防护用品 自吸过滤式防颗粒物呼吸器 Respiratory protective equipment. Non-powered air-purifying particle respirator GB 2626-2019 呼吸防护 自吸过滤式防颗粒物呼吸器 GB/T 18664-2002 呼吸防护用品的选择、使用与维护 Selection,use and maintenance of respiratory protective equipment GB 19083-2010 医用防护口罩技术要求 Technical requirements for protective face mask for medical use GB/T 23465-2009 呼吸防护用品 实用性能评价 GB/T 32610-2016 日常防护型口罩技术规范 Technical specification of daily protective mask YY 0469-2011 医用外科口罩 Surgical mask YY/T 0691-2008 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、水平注射) Clothing for protection against infectious agents. Medical face masks. Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) YY/T 0866-2011 医用防护口罩总泄漏率测试方法 Total inward leakage determination method of protective face mask for medical use YY/T 0969-2013 一次性使用医用口罩 Single-use medical face mask YY/T 1497-2016 医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法 Evaluation test method for the viral filtration efficiency (VFE)of medical protective face mask materials. Test method using Phi-X174 bacteriophage DB 50/ 107-2003 医用纱布口罩 DB 62/T 518-1998 一次性使用无纺布系列医疗卫生用品 DB 65/T 2028-2003 医用脱脂纱布口罩 Medical purified ganuze mask CNS 14258-1998 呼吸防護具之選擇、使用及維護方法 Guidance for seclection use and maintenance of respiratory protective devices CNS 14755-2003 拋弃式防尘口罩 Disposable dust respirators CNS 14756-2003 附加活性碳拋弃式防尘口罩 Disposable dust respirators with activated - carbon CNS 14774-2018 醫用面(口)罩 Medical face masks CNS 14775-2003 醫用面罩材料細菌過濾效率試驗法─使用金黃色葡萄球菌生物氣霧 Method of test for evaluating the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of staphylococcus aureus CNS 14776-2003 醫用面罩對合成血液穿透阻力的試驗法─以已知速度定量的水平噴灑 Method of test for resistance of medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity) CNS 14777-2003 醫用面罩空氣交換壓力之試驗法 Method of test for air exchange pressure of medical face mask CNS 16076-2018 呼吸防護裝置－全面罩－要求、試驗、標示 Respiratory protective devices. Full face masks. Requirements, testing, marking 国际 ISO 22609-2004 传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平注射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) 欧洲 EN 136-1998+AC-2003 呼吸保护装置 全面罩 要求、测试和标记 Respiratory protective devices. Full face masks. Requirements,testing,marking EN 140-1998+AC-1999 呼吸保护装置 半面罩和1/4面罩式 要求、测试和标记 Respiratory protective devices. Half masks and quarter masks. Requirements,testing,marking EN 143-2000 呼吸保护装置 - 粒子滤波 - 要求、测试、标识 Respiratory protective devices. Particle filters. Requirements,testing,marking Including corrigenda July 2002 and March 2005;Including Amendment A1:June 2006 EN 149-2001 呼吸防护装置.颗粒防护用过滤半面罩.要求、检验和标记 Respiratory protective devices - Filtering half masks to protect against particles - Requirements testing marking EN 149-2001+A1-2009 呼吸保护装置 颗粒防护用过滤半遮罩 要求、测试和标记 Respiratory protective devices. Filtering half masks to protect against particles. Requirements,testing,marking EN 529-2005 呼吸保护器 选择、使用、维护和保养建议 指导性文件 Respiratory protective devices. Recommendations for selection,use,care and maintenance. Guidance document Supersedes CR 529:1993 EN 12942-1998+A2-2008 呼吸保护装置 全面罩、半面罩或1/4面罩式动力过滤装置 要求、测试和标记 Respiratory protective devices. Power assisted filtering devices incorporating full face masks,half masks or quarter masks. Requirements,testing,marking EN 14387-2004+A1-2008 呼吸保护装置 气体过滤器和组合过滤器 要求、测试和标记 Respiratory protective devices. Gas filter(s) and combined filter(s). Requirements,testing,marking EN 14683-2019+AC-2019 医用口罩 要求和试验方法 Medical face masks - Requirements and test methods 美国 ASTM F1862/F1862M-2017 医用口罩抗人工合成血渗透的标准试验方法(已知速度下固定体积的水平投影) Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) ASTM F2100-2019 医用口罩材料性能标准规范 Standard Specification for Performance of Materials Used in Medical Face Masks ASTM F2101-2019 用金黄色葡萄球菌生物气溶胶评价医用口罩材料的细菌过滤效率(BFE)的标准试验方法 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus ASTM F2299/F2299M-2003(2017) 用乳胶球测定医用口罩材料被微粒渗透的初始效率的标准试验方法 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres CFR 42-84-1995解释指南 NIOSH颗粒物防护口罩的选择和使用指南 NIOSH Guide to the Selection and Use of Particulate Respirators 英国 BS EN 136-1998 呼吸保护装置.全面罩.要求、试验、标记 Respiratory protective devices. Full face masks. Requirements,testing,marking BS EN 140-1999 呼吸保护装置 半口罩和四分之一口罩 要求、试验、标记 Respiratory protective devices. Half masks and quarter masks. Requirements,testing,marking BS EN 143-2000 呼吸防护装置 微粒过滤器 要求、测试、标记 Respiratory protective devices. Particle filters. Requirements,testing,marking BS EN 149-2001+A1-2009 呼吸保护装置 可防微粒的过滤式半面罩 要求、试验、标记 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking BS EN 529-2005 呼吸保护装置 选择、使用、保养和维护的建议 指导文档 Respiratory protective devices. Recommendations for selection,use,care and maintenance. Guidance document BS EN 14387-2004+A1-2008 呼吸防护装置 气体过滤器和组合过滤器 要求、试验、标志 Respiratory protective devices. Gas filter(s) and combined filter(s). Requirements, testing, marking BS EN 14683-2019 医用口罩 要求和试验方法 Medical face masks. Requirements and test methods 德国 DIN EN 136-1998 呼吸保护器.全面罩.要求、检验、标志 Respiratory protective devices. Fullface masks. Requirements, testing, marking; German version EN136:1997 DIN EN 140-1998 呼吸保护器.半面和四分之一面罩.要求、检验、标记 Respiratory protective devices. Half masks and quarter-masks. Requirements, testing, marking; German version EN140:1998 DIN EN 149-2009 呼吸保护装置 过滤半面罩以防止颗粒物 要求，测试，标记; Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking; German version EN149:2001+A1:2009 DIN EN 529-2006 呼吸保护器 选择、使用、维护和保养建议 指导性文件 Respiratory protective devices. Recommendations for selection, use, care and maintenance. Guidance document; German version EN529:2005 DIN EN 14683-2019 医用口罩 要求和试验方法 Medical face masks - Requirements and test methods; German version EN 14683:2019+AC:2019 法国 NF S76-014-2009 呼吸保护装置.颗粒防护用过滤式半面罩.要求、试验、标记 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking NF S76-034-1998 呼吸保护装置与防护罩或防护面具结合的带动力粒子过滤装置.要求,试验, 标志 Respiratory protective devices. Powered filtering devices incorporating a helmet or a hood. Requirements, testing, marking. NF S97-166-2014 医用口罩 要求和试验方法 Medical face masks - Requirements and test methods NF EN 140-1998 呼吸保护装置.1/2 和1/4 防毒面具.要求,试验和标志 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking NF EN 12941-1998 呼吸保护装置与防护罩或防护面具结合的带动力粒子过滤装置.要求,试验, 标志 Respiratory protective devices. Powered filtering devices incorporating a helmet or a hood. Requirements, testing, marking. 澳大利亚 AS/NZS 1715-2009 呼吸保护设备的选择 使用和维护 Selection, Use And Maintenance Of Respiratory Protective Equipment AS/NZS 1716-2012 呼吸防护设备 Respiratory protective devices 日本 JIS T8062-2010 预防传染性病原体的防护服.面罩.防止人造血浆渗透的试验方法(确定容量,水平注射) Clothing for protection against infectious agents -- Face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) JIS T8150-2006 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 JIS T8159-2006 呼吸防护面具漏泄率试验方法 Leakage rate testing method for respiratory protective devices 韩国 KS M 6673-2008 防尘口罩 Dust respirators KS K ISO 22609-2018 抗传染病防护服 医用口罩 合成血液抗渗透的试验方法(确定容量,水平注射) Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood(fixed volume, horizontally projected) 越南 TCVN 8389-1-2010 医用口罩. 第1部分: 普通医用口罩 Medical face mask. Part 1: Normal medical face mask. TCVN 8389-2-2010 医疗口罩. 第2部分: 防细菌医用口罩 Medical face mask. Part 2: Medical face mask preventing bacteria. TCVN 8389-3-2010 医用口罩. 第3部分: 防有毒化学物质医用口罩 Medical face mask. Part 3: Medical face mask preventing of toxic chemicals 其他国家 DS/ISO 22609-2005 防病毒衣物. 医用口罩. 合成血液渗透性测试方法(确定容量,水平注射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) GOST 12.4.166-2018 职业安全标准体系 呼吸保护装置 面具 一般规范 Occupational Safety Standards System. Respiratory Protective Devices. Facepiece. General Specifications GOST 12.4.285-2015 职业安全标准体系 呼吸保护装置 防微粒过滤半面罩 一般规范 Occupational safety standards system. Respiratory protective devices. Filter self-rescuer. General technical requirements. Test methods 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 Occupational safety standards system. Respiratory protective devices. Filtering half masks to protect against particles. General specifications GOST R 58396-2019 医疗口罩 要求和测试方法 Medical Face Masks. Requirements And Test Methods AS/NZS 1715-2009 呼吸保护设备的选择 使用和维护 Selection, Use And Maintenance Of Respiratory Protective Equipment AS/NZS 1716-2012 呼吸防护设备 Respiratory protective devices SANS 1866-1-2018 医疗设备 第1部分 医用口罩 Medical devices Part 1: Medical face masks SANS 50136-1998 呼吸保护装置. 全面罩. 要求、测试、标记 Respiratory Protective Devices. Full Face Masks. Requirements, Testing, Marking SANS 50140-1998 呼吸保护装置. 半面罩和四分之一面罩. 要求、测试、标记 Respiratory Protective Devices. Half Masks And Quarter Masks. Requirements, Testing, Marking SS 548-2009 选择、使用和维修呼吸保护装置 Code of practice for selection, use and maintenance of respiratory protective devices ABNT NBR 13694-1996 呼吸保护装置 半面罩和四分之一面罩 规范 Respiratory protective devices. Half masks and quarter masks. Specification ABNT NBR 13695-1996 呼吸保护装置 全面罩 规范 Respiratory protective devices. Full face masks. Specification ABNT NBR 13698-2011 呼吸保护装置 颗粒过滤半面罩 Respiratory protective devices. Filtering half mask to protect against particles IS 14166-1994 呼吸防护装置：全面罩 Respiratory protective devices : Full face masks IS 14746-1999 呼吸防护装置-半面罩和四分之一面罩 Respiratory Protective Devices - Half Masks And Quarter Masks IS 9473-2002 呼吸防护装置-防止颗粒的过滤半面罩 Respiratory Protective Devices - Filtering Half Masks to Protect Against Particles UNI EN 14683-2019 医用口罩 要求和试验方法 Medical face masks - Requirements and test methods IS 9623-2008 呼吸防护装置的选择、使用和维护-规程 Selection, use and maintenance of respiratory protective devices - Code of practice UNE EN 14683-2014 医用口罩 要求和试验方法 Medical Face Masks - Requirements And Test Methods 第二部分 消毒剂相关国内外标准 类别 标准号 中文题名 英文题名 中国 GB/T 10666-2019 次氯酸钙（漂粉精） Calcium hypochlorite GB 16383-2014 医疗卫生用品辐射灭菌消毒质量控制 Quality control for radiation sterilization of medical and hygienical products GB 18280-2000 医疗保健产品灭菌 确认和常规控制要求 辐射灭菌 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization GB/T 19104-2008 过氧乙酸溶液 Peracetic acid solution GB/T 19106-2013 次氯酸钠 Sodium hypochlorite GB 19193-2015 疫源地消毒总则 General principle on disinfection for infectious focus GB/T 19633-2005 最终灭菌医疗器械的包装 Packaging for terminally sterilized medical devices GB/T 20468-2006 临床实验室定量测定室内质量控制指南 Guideline for internal quality control for quantitative measurements in clinical laboratory GB/T 20469-2006 临床实验室设计总则 General guideline of the clinical laboratory design GB/T 20470-2006 临床实验室室间质量评价要求 Requirements of external quality assessment for clinical laboratories GB/T 23854-2009 溴氯海因 Bromochloro-5,5-dimethylhydantoin GB/T 23854-2019 溴氯海因 Bromochloro-5,5-dimethylhydantoin GB/T 26366-2010 二氧化氯消毒剂卫生标准 Hygienic standard for chlorine dioxide disinfectant GB/T 26367-2010 胍类消毒剂卫生标准 Hygienic standard for biguanides disinfectants GB/T 26368-2010 含碘消毒剂卫生标准 Hygienic standard for iodine disinfectants GB/T 26369-2010 季铵盐类消毒剂卫生标准 Hygienic standard for quaternary ammonium disinfectant GB/T 26370-2010 含溴消毒剂卫生标准 Hygienic standard for disinfectants with bromine GB/T 26371-2010 过氧化物类消毒剂卫生标准 Hygienic standard for peroxide disinfectants GB/T 26372-2010 戊二醛消毒剂卫生标准 Hygienic standard for glutaraldehyde disinfectant GB/T 26373-2010 乙醇消毒剂卫生标准 Hygienic standard for alcohol disinfectants GB/T 27947-2011 酚类消毒剂卫生要求 Hygienic requirements for phenol disinfectant GB 27948-2011 空气消毒剂卫生要求 Hygienic requirements for air disinfectant GB/T 27949-2011 医疗器械消毒剂卫生要求 Hygienic requirements for medical items disinfection GB 27950-2011 手消毒剂卫生要求 Hygienic requirements for hand antiseptic agents GB 27951-2011 皮肤消毒剂卫生要求 Hygiene requirements for skin disinfectant GB 27952-2011 普通物体表面消毒剂的卫生要求 Hygienic requirements for surface disinfectants GB 27953-2011 疫源地消毒剂卫生要求 Hygienic requirements of disinfectant for infectious focus GB 27954-2011 黏膜消毒剂通用要求 General standard for disinfectant of mucous membrane GB 27955-2011 过氧化氢气体等离子体低温灭菌装置的通用要求 General requirements for low-temperature hydrogen peroxide gas plasma sterilizer GB 28232-2011 臭氧发生器安全与卫生标准 Safety and sanitation standard for ozone generator GB 28233-2011 次氯酸钠发生器安全与卫生标准 Safety and hygienic standard for disinfection by sodium hypochlorite generator GB 28234-2011 酸性氧化电位水生成器安全与卫生标准 Safety and sanitation standard for acidic electrolyzed-oxidizing water generator GB 28235-2011 紫外线空气消毒器安全与卫生标准 Safety and sanitary standard for ultraviolet appliance for air disinfection GB 28931-2012 二氧化氯消毒剂发生器安全与卫生标准 Safety and sanitation standard for chlorine dioxide disinfectant generator GB/T 30224-2013 刚地弓形虫试验临床应用 Clinical use of tests for Toxoplasma gondii GB 30689-2014 内镜自动清洗消毒机卫生要求 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes GB/T 30690-2014 小型压力蒸汽灭菌器灭菌效果监测方法和评价要求 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer GB/T 33417-2016 过氧化氢气体灭菌生物指示物检验方法 Test method of biological indicator for hydrogen peroxide vapour sterilization processes GB/T 33418-2016 环氧乙烷灭菌化学指示物检验方法 Test method of chemical indicator for ethylene oxide sterilization processes GB/T 33419-2016 环氧乙烷灭菌生物指示物检验方法 Test method of biological indicator for ethylene oxide sterilization processes GB/T 33420-2016 压力蒸汽灭菌生物指示物检验方法 Evaluation standard of biological for moist heat sterilization processes GB/T 36758-2018 含氯消毒剂卫生要求 Hygienic requirements for disinfectants with chlorine YY/T 0215-2016 医用臭氧消毒设备 Ozone disinfector for medical purpose YY 0970-2013 含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants WS/T 327-2011 消毒剂杀灭分枝杆菌实验评价要求 Requirements of mycobactericidal evaluation for disinfectant in laboratory WS/T 466-2014 消毒专业名词术语 Disinfection professional terms WS/T 496-2017 临床实验室质量指标 Quality indicators in clinical laboratories WS/T 497-2017 侵袭性真菌病临床实验室诊断操作指南 Performance guideline for clinical laboratory diagnosis of invasive fungal diseases WS/T 498-2017 细菌性腹泻临床实验室诊断操作指南 Performance guideline for clinical laboratory diagnosis of bacterial diarrhea WS/T 508-2016 医院医用织物洗涤消毒技术规范 Regulation for washing and disinfection technique of medical textiles in healthcare facilities WS/T 514-2017 临床检验方法检出能力的确立和验证 Establishment and verification of detection capability for clinical laboratory measurement procedures WS 628-2018 消毒产品卫生安全评价技术要求 WS/T 646-2019 过碳酸钠消毒剂卫生要求 WS/T 648-2019 空气消毒机通用卫生要求 GA/T 933-2011 生物样品中氟乙酸根离子的气相色谱和气相色谱-质谱联用检验方法 GC and GC-MS examination methods for monofluorocetate anion in biological samples GA/T 934-2011 生物样品中次乌头碱、乌头碱、中乌头碱的液相色谱-串联质谱检验方法 SN/T 1823-2006 医学媒介生物卫生处理常用药物及处理方法 Common drugs and methods of sanitary treatment for medical vectors SN/T 2064-2008 国际直达列车突发公共卫生事件处理规程 Codes for the rapid response to the public health emergency occurred in international trains SN/T 2069-2008 国际旅行卫生保健中心 质量管理标准及评价 Quanlity management criterion and evaluation of international travel healthcare centre SN/T 4387-2015 进出口一次性使用卫生用品检验规程 Rules for inspection of disposable sanitary products for import and export DB11/ 116-1999 送餐企业卫生规范 DB65/T 2176-2004 高原地区医疗机构消毒灭菌工作规程 Rules of Disinfecting Sterilization in Medical Institute on Plateau DB65/T 2203-2005 海拔2000m以上地区压力蒸汽灭菌效果评价方法与标准 Methods and Standards to Evaluting the Efficacy of High.pressure Steam Sterilization at Altitude Above 2000m DB13/T 491-2003 有害生物防制服务质量要求 DB31/ 405-2008 公共场所空调通风系统运行卫生要求 DB31/ 358-2006 驱避剂卫生安全要求 DB31/ 354-2005 消毒剂生产环境卫生要求 DB31/ 486-2010 献血屋(点)安全卫生要求 Requirements for Fixed Collection Sites DB31/T 794-2014 老年护理院分级护理要求 Requirments of grading nursing in Geriatric Nursing Hospital DB34/T 1352-2011 住宿业卫生服务规范 Hygienic Service Specification for Lodging Industry DB44/T 951-2011 水产品加工过程臭氧及过氧化氢使用准则 Guidelines for the use of ozone and hydrogen peroxide in fishery products CNS 5937-1980 灭菌盘（消毒盘） Sterilizing Trays CNS 14622-1-2002 保健产品之灭菌─生物指示剂─第一部份：通则 Sterilization of health care products-biological indicators-part 1：General CNS 14622-2-2002 保健产品之灭菌─生物指示剂─第二部分：使用环氧乙烷灭菌的生物指示剂 Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization CNS 14622-3-2002 保健产品之灭菌─生物指示剂─第三部分：用于湿热灭菌的生物指示剂 Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization CNS 14623-1-2002 保健产品之灭菌─化学指示剂─第一部分：一般规定 Sterilization of health care products-chemical indicators-Part 1：General requirements CNS 14708-2002 医疗器材－环氧乙烷灭菌确效与例行管制 Medical decice-validation and routine control of ethylene oxide strilization CNS 14709-2002 保健产品之灭菌－辐射灭菌确效与例行管制规定 Sterilization of health care products-requirements for validation and routine control-radiation sterliization 国际 ISO 6579 CORR 1-2004 食品和动物饲料的微生物学.沙门氏菌属检测的水平法.技术勘误1 Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp,; Technical Corrigendum 1 ISO 11140-1:2014 保健品消毒. 化学指示物. 通用要求 Sterilization of health care products — Chemical indicators — Part 1: General requirements ISO 11140-3-2007 卫生保健品的灭菌.化学指示剂.第3部分:布维-狄克(Bowie and Dick-type)蒸汽穿透试验用2级指示剂体系 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test ISO 11140-4-2007 卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维-狄(Bowie and Dick)形式试验的2级指示剂 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration ISO 11140-5-2007 卫生保健品的灭菌.化学指示剂.第5部分:布维-狄克形式(Bowie and Dick-type)除气试验的2级指示剂 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests ISO 11607-1:2019 最终灭菌医疗器械的包装. 第1部分：材料、无菌屏障系统和包装系统的要求 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 13408-1-2008 医疗保健产品的无菌加工.第1部分:一般要求 Aseptic processing of health care products - Part 1: General requirements ISO 13408-2-2018 医疗保健产品的无菌加工.第2部分:除菌过滤 Aseptic processing of health care products - Part 2: Sterilizing filtration ISO 13408-3-2006 卫生保健产品的无菌工艺.第3部分:冻干法 Aseptic processing of health care products - Part 3: Lyophilization ISO 13408-6-2005 保健产品的无菌加工.第6部分:隔离器系统 Aseptic processing of health care products - Part 6: Isolator systems ISO 18472:2018 保健品消毒. 化学指示物. 试验设备 Sterilization of health care products — Biological and chemical indicators — Test equipment CIE 155-2003 紫外线空气消毒法 ULTRAVIOLET AIR DISINFECTION (G) 欧洲 EN 1499-2013 化学消毒剂和防腐剂.消毒洗手液.检验方法和要求(第2阶段/2级) Chemical Disinfectants and Antiseptics - Hygienic Handwash - Test Method and Requirements (Phase 2/Step 2) EN 1811:2011+A1:2015 从插入人体穿孔部分和与皮肤直接和长期接触的物品的所有柱组件中释放镍的参考试验方法 Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin 美国 ANSI/AAMI/ISO 13408-2-2003 医疗保健产品的无菌加工.第2部分:过滤 Aseptic Processing of health care products - Part 2: Filtration ANSI/AAMI/ISO 13408-3-2006 卫生保健产品的无菌工艺.第3部分:冻干法 Aseptic Processing of health care products - Part 3: Lyophilization ANSI/AAMI/ISO 13408-4-2005 保健产品的无菌加工.第4部分:就地清洗技术 Aseptic Processing of health care products - Part 4: Clean-in-place technologies ANSI/AAMI/ISO 13408-5-2006 保健产品的无菌加工.第5部分:现场消毒 Aseptic Processing of health care products - Part 5: Sterilization in place ANSI/AAMI/ISO 13408-6-2005 保健产品的无菌加工.第6部分:隔离器系统 Aseptic Processing of health care products - Part 6: Isolator systems ANSI/AAMI/ISO 13408-6/A1-2013 保健产品的防腐处理.第6部分:隔离器.修改件1 Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1 ANSI/AAMI/ISO 13408-7-2012 保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products ANSI/AAMI ST79/A 3.1-2012 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.3-2012 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.4-2012 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.6-2012 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79/A 3.7-2012 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/American Society of Sanitary Engineering SERIES 12000-2018 所有建筑系统感染控制风险评估专业资格标准 Professional Qualifications Standard for Infection Control Risk Assessment for All Building Systems ANSI/ASTM E2553-2007 自动通用卫生保健识别系统实施用指南 Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System ANSI/MEDBIQ PP.10.1-2008 卫生保健专业简介 Healthcare Professional Profile ANSI/NSF 49(i14)-2008 II级(层流)生物安全室 Class II (laminar flow) biosafety cabinetry ANSI/NSF 49(i15r2)-2008 生物安全柜:设计,制作,性能和行业认证 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification ANSI/NSF 49(i27)-2011 生物安全柜:设计,制作,性能和行业认证 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ANSI/NSF 49(i42)-2011 生物安全柜:设计,制作,性能和行业认证 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ANSI/NSF 49(i43)-2011 生物安全厨柜:设计,建造,性能和实地认证 Biosafety Cabinetry: Design, Construction, Performance and Field Certification ASHRAE QC-06-066-2006 在飞机舱实体模拟的空降疾病传播的示踪研究 Tracer Study of Airborne Disease Transmission in an Aircraft Canin Mock-Up CFR 42-70.1-2017 公共卫生.第70部分：州际隔离.第70.1节：一般定义. Public health. Part 70: Interstate quarantine. Section 70.1: General definitions. CFR 42-70.5-2017 公共卫生.第70部分：州际隔离.第70.5节：与联邦隔离、隔离或有条件释放令下的旅行者有关的要求. Public health. Part 70: Interstate quarantine. Section 70.5: Requirements relating to travelers under a Federal order of isolation, quarantine, or conditional release. CFR 42-70.6-2017 公共卫生.第70部分：州际隔离.第70.6节：逮捕和拘留患有可隔离传染病的人. Public health. Part 70: Interstate quarantine. Section 70.6: Apprehension and detention of persons with quarantinable communicable diseases. CFR 42-70.10-2017 公共卫生.第70部分：州际隔离.第70.10节：公共卫生预防措施，以发现传染病. Public health. Part 70: Interstate quarantine. Section 70.10: Public health prevention measures to detect communicable disease. CFR 42-70.11-2017 公共卫生.第70部分：州际隔离.第70.11节：航空公司经营的飞机上死亡或生病的报告. Public health. Part 70: Interstate quarantine. Section 70.11: Report of death or illness onboard aircraft operated by an airline. CFR 42-70.12-2017 公共卫生.第70部分：州际隔离.第70.12节：体检. Public health. Part 70: Interstate quarantine. Section 70.12: Medical examinations. CFR 42-70.13-2017 公共卫生.第70部分：州际隔离.第70.13节：支付护理和治疗费用. Public health. Part 70: Interstate quarantine. Section 70.13: Payment for care and treatment. CFR 42-70.14-2017 公共卫生.第70部分：州际隔离.第70.14节：有关发出联邦检疫、隔离或有条件释放令的要求. Public health. Part 70: Interstate quarantine. Section 70.14: Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.15-2017 公共卫生.第70部分：州际隔离.第70.15节：强制重新评估用于隔离、隔离或条件释放的联邦订单. Public health. Part 70: Interstate quarantine. Section 70.15: Mandatory reassessment of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.16-2017 公共卫生.第70部分：州际隔离.第70.16节：对联邦隔离令、隔离令或有条件释放令的医学审查. Public health. Part 70: Interstate quarantine. Section 70.16: Medical review of a Federal order for quarantine, isolation, or conditional release. CFR 42-70.17-2017 公共卫生.第70部分：州际隔离.第70.17节：与联邦检疫、隔离或有条件释放有关的行政记录. Public health. Part 70: Interstate quarantine. Section 70.17: Administrative records relating to Federal quarantine, isolation, or conditional release. CFR 42-405.373-2017 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第C子部分：暂停付款，追回多付款项，偿还奖学金和贷款.第405.37节：程序用于抵销或收回的定金. Public health. Part405: Federal health insurance for the aged and disabled. Subpart C: Suspension of payment, recovery of overpayments, and repayment of scholarships and loans. Section405.373 : Proceeding for offset or recoupment. CFR 42-405.2413-2017 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第X子部分：农村卫生诊所和联邦合格医疗中心服务.第405.2413节：与医生服务有关的服务和用品. Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2413 : Services and supplies incident to a physician's services. CFR 42-405.2415-2017 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第X子部分：农村卫生诊所和联邦合格医疗中心服务.第405.2415节：服务事故和直接监督. Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2415 : Incident to services and direct supervision. CFR 42-410.26-2017 公共卫生.第410部分：补充医疗保险福利.第 B子部分：医疗和其他卫生服务.第410.26节：向医生提供的服务和用品事件：条件. Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.26 : Services and supplies incident to a physician's professional services: Conditions. CFR 42-410.79-2017 公共卫生.第410部分：补充医疗保险福利.第 B子部分：医疗和其他卫生服务.第410.79节：医疗保健糖尿病预防方案扩大模式：覆盖条件. Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.79 : Medicare Diabetes Prevention Program expanded model: Conditions of coverage. CFR 42-411.357-2017 公共卫生.第411部分：医疗保险除外和医疗保险支付的限制.第 J子部分：提供指定保健服务的医生和实体之间的财务关系.第411.357 节：与赔偿安排有关的禁止转介的例外情况. Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.357: Exceptions to the referral prohibition related to compensation arrangements. CFR 42-411.372-2017 公共卫生.第411部分：医疗保险除外和医疗保险支付的限制.第 J子部分：提供指定保健服务的医生和实体之间的财务关系.第411.372 节：提交请求的程序. Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.372: Procedure for submitting a request. CFR 42-414.22-2017 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第411.372 节：相对价值单位(RVU). Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.22: Relative value units (RVUs). CFR 42-414.90-2017 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第414.90节：医师质量报告制度. Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.90: Physician Quality Reporting System (PQRS). CFR 42-414.94-2017 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第414.94节：先进诊断成像服务的适当使用标准. Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.94: Appropriate use criteria for advanced diagnostic imaging services. ANSI/AAMI/ISO 13408-6-2005 保健产品的无菌加工.第6部分:隔离器系统 Aseptic Processing of health care products - Part 6: Isolator systems ANSI/AAMI/ISO 13408-7-2012 保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products ASTM E1327-2007 利用手指甲区域评估抗菌洗手液配方的标准试验方法 Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions ASTM E1714-2000 通用保健识别符(UHTD)特性的标准指南 Standard Guide for Properties of a Universal Healthcare Identifier (UHID) ASTM E1891-2010a 测定抗菌剂抗选定微生物的生存曲线和计算D值及浓度系数的标准指南 Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient ASTM E2042-1999 可控区域和清洁室的清洁和维修的标准实施规程 Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms ASTM E2720-2010 当表层沾有人体病原性病毒时用于评估透气材料净化程序效能的标准试验方法 Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses ASTM E2721-2010 评定遭到含有人类致病性病毒的飞沫攻击时表面净化程序效能的标准试验方法 Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses ASTM E2799-2011 用 MBEC 化验测试消毒剂对绿脓杆菌(Pseudomonas aeruginosa)生物膜功效的标准试验方法 Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay ASTM E3058-2016 手消毒剂杀伤活性测定方法 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations ASTM F1114-2006 商业用的热消毒筒,槽和架式水驱动旋转喷射器皿站 Standard Specification for Heat Sanitizing Commercial Pot, Pan, and Utensil Station Rack Type Water-Driven Rotary Spray 英国 BS 3970-1-1990 医疗制品用灭菌消毒设备.第1部分:一般要求规范 Sterilizing and disinfecting equipment for medical products. Specification for general requirements BS 3970-2-1991 医疗制品用灭菌消毒设备.第2部分:装含水液体的密封硬质容器用蒸汽消毒器规范 Sterilizing and disinfecting equipment for medical products. Specification for steam sterilizers for aqueous fluids in sealed rigid containers BS 6256-1989 医用蒸汽消毒纸袋、纸盒和纸筒用纸规范 Specification for paper for steam sterilization paper bags, pouches and reels for medical use BS CWA 15793-2011 实验室生物危害管理 Laboratory biorisk management BS CWA 16833-2014 整体管理棕色地带更新的术语表 (GoT-HOMBRE) Glossary of Terms for Holistic Management of Brownfield Regeneration (GoT-HOMBRE) BS DD CEN ISO/TS 17665-2-2009 保健产品的消毒.潮热.ISO 17665-1应用指南 Sterilization of health care products - Moist heat - Guidance on the application of ISO 17665-1 BS EN 13549-2001 清洁服务.质量度量系统的基本要求和推荐方法 Cleaning services - Basic requirements and recommendations for quality measuring systems BS EN ISO 11137-3-2007 卫生保健产品的灭菌.辐射.剂量测定方面的指南 Sterilization of health care products - Radiation - Guidance on dosimetric aspects BS EN ISO 11140-3-2009 保健品灭菌.化学指示剂.蒸汽渗透布维-狄(Bowie和Dick)型试验2级指示剂系统 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test BS EN ISO 15882-2008 保健产品的消毒.化学指示剂.选择、使用和结果说明用指南 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results BS ISO 11140-5-2007 卫生保健品灭菌.化学指示剂.布维-狄(Bowie和Dick)型除气试验用2级指示剂 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests BS ISO 21527-1-2008 食品和动物饲料的微生物学.酵母和霉菌的计数用水平方法.水活性大于0.95的产品用菌落计数技术 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Colony count technique in products with water activity greater than 0,95 BS PAS 5748-2014 医院清洁服务的规划, 应用, 测量以及审查规格 Specification for the planning, application, measurement and review of cleanliness services in hospitals 德国 DIN 58949-2-2014 消毒。蒸汽消毒仪 第二部分：要求 德语和英语文本 Disinfection. Steam disinfection apparatus. Part2: Requirements; Text in German and English DIN 58949-3-2012 消毒 蒸汽消毒装置 第三部分：效率测试 Disinfection. Steam disinfection apparatus. Part3: Efficiency testing DIN 58949-4-2014 消毒。蒸汽消毒仪 第4部分：功效测试的生物指标 Disinfection. Steam disinfection-apparatus. Part4: Biological indicators for efficacy tests DIN 58949-6-2015 消毒。蒸汽消毒仪 第六部分：蒸汽消毒设备的运行，其安装要求及其供应来源 Disinfection. Steam disinfection apparatus. Part6: Operation of steam disinfection apparatus, their requirements for the installation and their supply sources DIN EN 285-2016 灭菌。蒸汽灭菌器。大型消毒器 Sterilization. Steam sterilizers. Large sterilizers; German version EN285:2015 DIN V ENV 12612-1997 医疗信息技术.卫生行业行政管理信息交换报文 Medical informatics - Messages for the exchange of healthcare administrative information; English version ENV 12612:1997 法国 NF S98-101-2-2008 卫生保健品的消毒.环氧乙烷.第2部分:ISO 11135-1应用指南 Sterilization of health care products - Ethylene oxide - Part 2 : guidance on the application of ISO 11135-1. NF V08-040-1-2008 食品和动物饲料的微生物学.酵母和霉菌的计数的水平方法.第1部分:水活性大于0.95的产品用菌落计数技术 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Part 1 : colony count technique in products with water activity greater than 0,95. 日本 JIS K3801-2000 微生物用HEPA过滤器的试验方法 Test method of HEPA filters for microbiological use JIS T7328-2005 医用甲醛气消毒器 Formaldehyde gas disinfecters for medical use 韩国 KS P 6115-2006 医用氧化乙烯气体消毒器 Ethylene oxide gas sterilizers for medical use KS P 6116-2006 医用氧化乙烯气体消毒器(小型) Ethylene oxide gas sterilizers for medical use(Small size) 其他国家 CAN/CSA-ISO 13958-2011 主要用于血液分析和相关治疗(第一版) Concentrés pour hémodialyse et thérapies apparentées (Première édition) CAN/CSA-Z22870-2007 重点护理即时检验(POCT). 质量和能力的要求(第一版) Point-of-care testing (POCT) - Requirements for quality and competence (First Edition) CSA EXP06-2015 评价预防感染和控制感染的新材料和技术(第一版) Evaluating emerging materials and technologies for infection prevention and control (First Edition) GOST 10385-2014 鱼类综合饲养人员. 通用规格 Combined feeding staffs for fishes. General specifications GOST 32375-2013 人类危险化学品检测. 皮肤过敏 Testing of chemicals of human hazard. Skin sensitisation GOST R 56677-2015 人身防范工程手段. 编码, 标识和标记. 通用要求 Means of physical protection engineering. Coding, identification and marking. General requirements AS/NZS 3896-2008 水.包括嗜肺军团菌的在内的军团菌的检查 Waters—Examination for Legionella spp. including Legionella pneumophila SNZ PAS 8170-2005 初级卫生保健实践管理系统 PRIMARY HEALTHCARE PRACTICE MANAGEMENT SYSTEMS SANS 1780-2018 一般用途过氧化氢和过氧乙酸产品的杀菌效果 Bactericidal efficacy of peroxide and peracetic acid based products for general use. UL 2783 BULLETIN-2015 UL安全标准 即时性手消毒产品的可持续性 Ul Standard For Safety Sustainability Of Instant Hand Antiseptic Products (Comments Due: March 16, 2015) 第三部份 手套相关国内外标准 国别 标准号 中文题名 英文题名 中国 GB 7543-2006 一次性使用灭菌橡胶外科手套 Single-use sterile rubber surgical gloves GB 10213-2006 一次性使用医用橡胶检查手套 Single-use medical rubber examination gloves GB/T 21869-2008 医用手套表面残余粉末的测定 Medical gloves.Determination of removable surface powder GB/T 21870-2008 天然胶乳医用手套水抽提蛋白质的测定. 改进Lowry法 Medical gloves made from natural rubber latex.Determination of water-extractable protein using the modified lowry method GB 24786-2009 一次性使用聚氯乙烯医用检查手套 Single-use medical poly (vinyl chloride) examination gloves GB 24788-2009 医用手套表面残余粉末、水抽提蛋白质限量 Limit for the removable surface powder and water-extractable protein of medical gloves YY/T 0616.1-2016 一次性使用医用手套.第1部分: 生物学评价要求与试验 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation YY/T 0616.2-2016 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 Medical glove for single use.Part 2:Requirements and testing for shelf life determination YY/T 0616.3-2018 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 Medical gloves for single use.Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions YY/T 0616.4-2018 一次性使用医用手套 第4部分: 抗穿刺试验方法 Medical glove for single use.Part 4:Test method for the puncturation resistance YY/T 0616.5-2019 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 Medical gloves for single use Part 5: Test Method for Permeation of Chemicals under Conditions of Continuous Contact CNS 12543-1997 外科手術用橡膠手套 Surgical rubber gloves CNS 12837-1991 一般医疗用聚氯乙烯手套 Polyvinyl Chloride Medical Gloves CNS 12838-1991 一般医疗用聚氯乙烯手套检验法 Method of Test for Polyvinyl Chloride Medical Gloves 国际 ISO 11193-1-2008 一次性医用检验手套. 第1部分: 橡胶乳胶或胶液制手套规范 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution ISO 11193-1 AMD 1-2012 一次性医用检验手套. 第1部分: 橡胶乳胶或胶液制手套规格.修改件1 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1 ISO 11193-2-2006 一次性医用检查手套. 第2部分: 聚乙烯(氯乙烯)制手套规范 Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride) ISO 12243-2003 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 ISO 21171-2006 医疗专用手套.可移动表面粉末的测定 Medical gloves - Determination of removable surface powder 欧洲　 EN 455-1-2000 一次性医用手套. 第1部分: 无孔试验和要求 Medical gloves for single use. Part 1: Requirements and testing for freedom from holes EN 455-2-2015 一次性医用手套. 第2部分: 物理性能要求和试验 Medical gloves for single use - Part 2: Requirements and testing for physical properties EN 455-3-2015 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 EN 455-4-2009 一次性医用手套. 第4部分: 保质期测定要求和检验 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination CEN/TR 16953-2017 一次性医用手套. 选择指南 Medical gloves for single use - Guidance for selection EN ISO 21171-2006 医疗专用手套.可移动表面粉末的测定 ISO 21171-2006 Medical gloves Determination of removable surface powder 美国 ASTM D3578-2019 橡胶检验手套标准规范 Standard Specification for Rubber Examination Gloves ASTM D5151-2006(2015) 检测医用手套漏孔的标准试验方法 Standard Test Method for Detection of Holes in Medical Gloves ASTM D5250-2019 医用聚氯乙烯手套的标准规范 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application ASTM D6124-2006(2017) 医用手套残余粉末的标准试验方法 Standard Test Method for Residual Powder on Medical Gloves ASTM D6319-2000a(2005) 医用腈橡胶检验手套的标准规范 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-2010 医用腈类检验手套的标准规范 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-2019 医用腈检验手套规格 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6355-1998(2003) 医用手套人重复损害修补试验的标准试验方法 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves ASTM D6977-2019 医疗检查用氯丁橡胶手套的标准规格 Standard Specification for Polychloroprene Examination Gloves for Medical Application ASTM D6978-2005(2019) 医用手套对化疗药物渗透阻力的评价的标准操作规程 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ASTM D7102-2010 测定无菌医用手套上的内毒素的标准指南 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves ASTM D7103-2018 医用手套评定的标准指南 Standard Guide for Assessment of Medical Gloves ASTM D7160-2016 医用手套有效期测定的标准实施规程 Standard Practice for Determination of Expiration Dating for Medical Gloves ASTM D7161-2016 测定典型仓库条件下存放的成熟医用手套实时有效期的标准实施规程 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions ASTM D7907-2014 测定医用检查手套表面杀菌作用的标准试验方法 Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves ANSI/ADA 102-1998 牙医用无菌丁二烯手套 Non-Sterile Nitrile Gloves for Dentistry ANSI/ADA 103-2001 牙医用无菌增塑聚氯乙烯手套 Non-Sterile Polyvinyl Chloride Gloves for Dentistry 英国 BS EN 455-1-2000 一次性医用手套 无孔要求和测试 Medical gloves for single use. Requirements and testing for freedom from holes BS EN 455-2-2015 一次性医用手套.物理性质的要求和测定 Medical gloves for single use. Requirements and testing for physical properties BS EN 455-3-2015 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. Requirements and testing for biological evaluation BS EN 455-4-2009 一次性医用手套.第4部分: 测定货架寿命的试验和要求 Medical gloves for single use Part 4: Requirements and testing for shelf life determination BS EN ISO 21171-2006 医疗专用手套.可移动表面粉末的测定 Medical gloves - Determination of removable surface powder BS ISO 12243-2003+A1-2012 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 Medical gloves made from natural rubber latex. Determination of water-extractable protein using the modified Lowry method BS PD CEN/TR 16953-2017 一次性医用手套. 选择指南 Medical gloves for single use. Guidance for selection 德国 DIN 58133-2008 医疗压缩袜 Medical compression hosiery DIN EN 455-1-2001 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; German version EN 455-1:2000 DIN EN 455-2-2015 一次性医用手套. 第2部分:物理特性用要求和试验.德文版本EN 455-2-2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2015 DIN EN 455-3-2015 一次性医用手套. 第3部分:生物评定要求和试验;德文版本EN 455-3-2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015 DIN EN 455-4-2009 医用手套一次性使用 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 DIN EN ISO 21171-2006 医疗专用手套. 可移动表面粉末的测定 (ISO 21171-2006) Medical gloves - Determination of removable surface powder (ISO 21171:2006) English version of DIN EN ISO 21171:2006-08 法国 NF S97-004-2006 医疗专用手套. 可移动表面粉末的测定 Medical gloves - Determination of removable surface powder. 泰国 TIS 1056.1-2013 一次性医用检查手套. 第1部分: 橡胶乳胶或橡胶溶液制手套规范 Single-use medical examination gloves part 1: specification for gloves made from rubber latex or rubber solution TIS 1056-2005 一次性医用检查手套. 第1部分: 橡胶乳胶或橡胶溶液制手套规范 Single.use medical examination gloves.part 1: specification for gloves made from rubber latex or rubber solution 越南 TCVN 6343-1-2007 一次性医用检查手套. 第1部分: 橡胶胶乳或胶液制手套规范 Single-use medical examination gloves.Part 1: Specification for gloves made from rubber latex or rubber solution TCVN 6343-2-2007 一次性医用检查手套. 第2部分: 聚乙烯(氯乙烯)制手套规范 Single-use medical examination gloves.Part 2: Specification for gloves made from poly (vinyl chloride) 其他国家 GOST EN 455-1-2014 一次性医用手套. 第1部分. 紧密性的测定方法 Medical gloves for single use. Part 1. Method for determination of tightness GOST EN 455-2-2014 一次性医用手套. 第2部分. 物理特性的测定方法 Medical gloves for single use. Part 2. Method for determination of physical-mechanical properties GOST R 52239-2004 一次性医疗检查手套. 第1部分: 橡胶乳胶或橡胶胶浆制手套规范 Single-use medical examination gloves. Part 1. Specification for gloves made from rubber latex or rubber solution GOST R 57397-2017 医疗检查用橡胶手套. 技术要求 Rubber examination medical gloves. Technical requirements GOST R 57402-2017 医用手套. 使用期限的测定 Medical gloves. Determination of expiration dating GOST R 57403-2017 医用聚氯乙稀手套. 技术要求 Poly(vinyl chloride) medical gloves. Technical requirements GOST R 57404-2017 医用手套. 质量评估指南 Medical gloves. Quality assessment guide SANS 11193-1-2010 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 SANS 15190-2016 医用手套 安全要求 Medical laboratories - Requirements for safety LST EN 455-1-2001 一次性医用手套. 第1部分:孔自由度试验和要求 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes LST EN 455-2-2015 一次性医用手套. 第2部分: 物理特性的要求和检验 Medical gloves for single use - Part 2: Requirements and testing for physical properties LST EN 455-3-2015 一次性医用手套. 第3部分: 生物评价的要求和试验 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation LST EN ISO 21171-2006 医用手套表面残余粉末的测定(ISO 21171-2006) Medical gloves - Determination of removable surface powder (ISO 21171:2006) SNI ISO 11193.1-2010 一次性医用检验手套. 第1部分:用橡胶乳和胶液制成的手套规范 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution SNI ISO 11193.2-2010 一次性医用检查手套. 第2部分: 聚氯乙烯制成的手套规格 Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride) STN EN 455-1-2002 一次性医用手套. 第1部分: 指孔间自由度的要求和试验 Medical gloves for single use. Part 1: Requirements and testing for freedom from holes STN EN 455-2-2015 一次性医用手套. 第2部分: 物理特性的要求和检验 Medical gloves for single use - Part 2: Requirements and testing for physical properties STN EN 455-4-2009 一次性医用手套. 第4部分: 测定货架寿命的要求和试验 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination ABNT NBR ISO 11193-1-2009/Amd 1-2015 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 ABNT NBR ISO 11193-1-2015 一次性医用检验手套 Single-use medical examination gloves ABNT NBR ISO 11193-2-2013 一次性使用的医疗检查手套 第2部分：由聚氯乙烯制成的手套 Single-use medical examination gloves Part 2: Specification for gloves made from poly (vinyl chloride) DS/EN 455-3-2007 一次性使用医用手套第3部分:生物学评价要求和测试 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation DS/EN ISO 21171-2006 医用手套可移动表面粉末的测定 Medical gloves - Determination of removable surface powder 第四部分 防护服相关国内外标准 国别 标准号 中文题名 英文题名 中国 GB 19082-2009 医用一次性防护服技术要求 Technical requirements for single-use protective clothing for medical use GB/T 20097-2006 防护服一般要求 Protective clothing - General requirements YY 0318-2000 医用诊断X射线辐射防护器具.第3部分:防护服和性腺防护器具 Protective device against diagnostic medical X-radiation.Part 3:Protective clothing and protective devices for gonads YY/T 0506.1-2005 病人、医护人员和器械用手术单、手术衣和洁净服 第1部分:制衣厂、处理厂和产品的通用要求 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 1:General requirements for manufacturers,processors and products YY/T 0506.2-2016 病人、医护人员和器械用手术单、手术衣和洁净服 第2部分：性能要求和试验方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 2: Performance requirements and test methods YY/T 0506.4-2016 病人、医护人员和器械用手术单、手术衣和洁净服 第4部分：干态落絮试验方法 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 4: Test method for linting in the dry state YY/T 0506.5-2009 病人、医护人员和器械用手术单、手术衣和洁净服 第5部分:阻干态微生物穿透试验方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 5:Test method for resistance to dry microbial penetration YY/T 0506.6-2009 病人、医护人员和器械用手术单、手术衣和洁净服 第6部分:阻湿态微生物穿透试验方法 Surigical drapes,gowns and clean air suits,used as medical devices,for patients,clinical staff and equipment. Part 6:Test method to determine the resistance to wet bacterial penetration YY/T 0506.7-2014 病人、医护人员和器械用手术单、手术衣和洁净服 第7部分:洁净度-微生物试验方法 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 7:Test methods for determination of cleanliness-mircrobial YY/T 0506.8-2019 病人、医护人员和器械用手术单、手术衣和洁净服 第8部分：产品专用要求 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 8-Special requirements for products YY/T 0689-2008 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 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 YY/T 0699-2008 液态化学品防护装备.防护服材料抗加压液体穿透性能测试方法 Clothing for protection against liquid chemicals.Determination of the resistance of protective clothing materials to penetration by liquids under pressure YY/T 0700-2008 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 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 YY/T 1425-2016 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 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 YY/T 1498-2016 医用防护服的选用评估指南 Guideline for evaluation of selection and use of medical protective clothing YY/T 1499-2016 医用防护服的液体阻隔性能和分级 Liquid barrier performance and classification of protective apparel intended for use in health care facilities YY/T 1632-2018 医用防护服材料的阻水性:冲击穿透测试方法 Water resistance of textiles for medical protective apparel.Impact penetration test 国际 ISO 16603-2004 防止接触血液和体液的防护服.防护服材料防止血液和体液渗透性的测定.使用人造血液的试验方法 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 ISO 16604-2004 防止接触血液和体液的防护服.防护服材料防止血液病原渗透性的测定.使用Phi-X 174噬菌体的试验方法 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-X 174 bacteriophage ISO 22609-2004 传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) ISO 22612-2005 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 欧洲 EN 14126-2003 防护服.防传病毒防护服的性能要求和试验方法.合并勘误表2004年9月 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents (Incorporating corrigendum September 2004) EN 14126-2003+AC-2004 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 EN ISO 22612-2005 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 EN 61331-3-2014 医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing@ eyewear and protective patient shields 美国 AAMI PB70-2012 FDA认可的用于卫生保健设施的防护服和防护单的液体阻隔性能及分类 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities FDA RECOGNIZED ANSI/PB70-2012 旨在用于医疗保健设施的防护服和防护层的液体屏障性能和分类（FDA认可） Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (FDA RECOGNIZED) ANSI/AAMI PB70-2012 医疗保健设施中使用的防护服和防护布的液体阻挡层性能和分类 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities ANSI/NFPA 1999-2008 急救医疗手术用防护服的标准 Standard on Protective Clothing for Emergency Medical Operations ASTM F903-2018 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 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 ASTM F1671/F1671M-2013 使用Phi-X174噬菌体渗透作为试验系统的血源性病原体对防护服使用的抗渗透材料用标准试验方法 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 ASTM F2878-2019 防护服材料耐皮下注射针头剌破性试验方法 Standard Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture ASTM F3050-2017 个人防护服及设备合格评定指南 Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment NFPA 1999-2018 紧急医疗服务用防护服和服装标准 Standard on Protective Clothing and Ensembles for Emergency Medical Operations (Effective Date: 8/21/2017) 英国 BS EN 14325-2018 化学药品防护服 化学防护服装材料、缝合线、联结和组合的试验方法和性能分类 Protective clothing against chemicals. Test methods and performance classification of chemical protective clothing materials,seams,joins and assemblages BS EN 61331-3-2014 防医疗诊断用X射线的防护装置. 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear and protective patient shields BS EN ISO 13688-2013 防护服 通用要求 Protective clothing. General requirements BS EN ISO 22612-2005 传染介质防护服.防干微生物渗入的试验方法 Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration BS ISO 16603-2004 防止接触血液和体液的防护服.防护服材料防止血液和体液渗透性的测定.使用人造血液的试验方法 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 德国 DIN EN 61331-3-2016 防医疗诊断用X射线的防护装置.第3部分:防护服,护目镜和患者防护罩(IEC 61331-3-2014).德文版本EN 61331-3-2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014 DIN EN ISO 22612-2005 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 日本 JIS T8060-2015 血液和体液接触的防护用服装.血液和体液渗透防护服装材料 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 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 JIS T8062-2010 预防传染性病原体的防护服.面罩.防止人造血浆渗透的试验方法（确定容量,平行注射） Clothing for protection against infectious agents -- Face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) JIS T61331-3-2016 医疗诊断用X射线防护装置. 第3部分: 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing, eyewear and protective patient shields 韩国 KS K ISO 22609-2012 传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积、水平喷射) Clothing for protection against infectious agents－Medical face masks－Test method for resistance against penetration by synthetic blood(fixed volume, horizontally projected) 其他国家 DS/EN 61331-3-1999 防止诊断医疗X射线辐射的保护装置 - 第3部分:生殖器防护服和保护装置 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads GOST R 57493-2017 医疗器械. 放射科材料防护服. 政府采购技术要求 Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases GOST R 57503-2017 医疗器械. 放射科患者防护服. 政府采购技术要求 Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases ABNT NBR IEC 61331-3-2004 防护服和性腺防护装置-对诊断医用X射线防护装置第3部分 Protective devices against diagnostic medical X-radiation Part 3- Protective clothing and protective devices for gonads LST EN 61331-3-2014 医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩(IEC 61331-3-2014) Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) UAE.S/GSO ISO 22609-2010 传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射) Clothing for protection against infectious agents -Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) STN EN 61331-3-2001 医用诊断X射线辐射防护器具. 第3部分: 防护服和性腺防护器具 Protective devices against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads STN EN 61331-3-2015 医用诊断X射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields IS 16545-2016 防止接触血液和体液的衣服-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 IS 16546-2016 防止接触血液和体液的衣服-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 第五部分 护目镜相关国内外标准 国别 标准号 中文题名 英文题名 中国 GB 14866-2006 个人用眼护具技术要求 The specifications for personal eye-protectors 国际 ISO 4849-1981 个人用护目镜 技术要求 Personal eye-protectors. Specifications first edition ISO 12609-1-2013 第1部分: 产品规范. 防护人体和动物用强光源用于化妆品和医疗用途的护目镜. 第1部分: 产品规范 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications. Part 1: Specification for products 欧洲 EN 166-2001 个人眼睛保护 - 规格 Personal Eye-Protection. Specifications 英国 BS EN 61331-3-2014 防医疗诊断用X射线的防护装置. 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear and protective patient shields 德国 DIN EN 61331-3-2016 防医疗诊断用X射线的防护装置.第3部分:防护服,护目镜和患者防护罩(IEC 61331-3-2014).德文版本EN 61331-3-2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014 法国 NF C74-228-3-2015 防医疗诊断用X射线的防护装置. 第3部分: 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation - Part 3 : protective clothing, eyewear and protective patient shields 日本 JIS T8147-2016 个人眼睛防护 Personal eye protectors 韩国 KS G ISO 12609-1-2014 第1部分:产品规范。防护人体和动物用强光源用于化妆品和医疗用途的护目镜。第1部分:产品规范 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products 其他国家 LST EN 61331-3-2014 医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩(IEC 61331-3-2014) Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) STN EN 61331-3-2015 医用诊断X射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields