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防护手套产品认证相关国内外标准汇编


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。本文将防护手套产品认证相关国内外标准进行整理汇编,供参考。

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

信息来源:国家标准馆
 

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