当前，我国新型冠状病毒肺炎的全民阻击战已经取得阶段性胜利，经济复苏也开始再度开放，同时也放松了包括居家隔离在内的管控措施。但国外疫情蔓延之势仍难以控制，各种防疫物资成为各国抢购的硬通货。我国作为世界工厂，为全球贡献了大部分抗疫物质。为帮助相关防疫物资生产企业快速打通出口通道，润扬仪器将口罩、手套、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 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 |
第三部分 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 |
