20100730170403_欧盟标准清单(1).xls

受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 序序号号 标标准准编编号号 new new 标标记记为为2010 7 72010 7 7日日 新新修修订订的的欧欧盟盟标标准准 标标准准名名称称文文件件来来源源实实施施时时间间 1MDD法规 欧洲共同体理事会法令 93 42 EEC 关于医疗器械的规定 MDD法规 外来文件1993 6 14 2 EN 1422 1997 A1 2009 医用消毒器 环氧乙烷灭菌器要求和测试方法 外来文件1997 9 3 EN 1041 2008 Information supplied by the manufacturer with medical devices制造商提供的器 械信息 知识产权1998 4 EN 556 1 2001 AC 2006 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 1 Requirements for terminally sterilized medical devices 外来文件2001 5EN724 1995 EN29001 EN46001及EN29002和EN46002对于无源医疗设备的应用说明 外来文件1995 6医疗器械审核检查表 medical devicice quality system regulation audit checklist 外来文件 798 79 EC 体外植入医疗器械指令外来文件 8ivd dd tf Technical Fiels Design Dossiers In vitro Diagnostics A Proposal 外来文件 9ivd dd tf 技术文件 设计档案 体外诊断 提案 非受控 公司翻译 10BS EN868 5 1999 Packaging materials and systems for medical devices which are to be sterilized 外来文件1999 11MEDDEV 2 12 1 2009医疗器械警戒系统指南外来文件2008 1 1 受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 序序号号 标标准准编编号号 new new 标标记记为为2010 7 72010 7 7日日 新新修修订订的的欧欧盟盟标标准准 标标准准名名称称文文件件来来源源实实施施时时间间 12EN 980 2008 Symbols for use in the labelling of medical devices外来文件2010 5 31 13BS EN 61010 2 040 2005 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 040 Particular requirements for sterilizers and washer disinfectors used to treat medical materials 购买2005 7 1497 23 EC PED 压力设备 Pressure equipmen 购买1997 5 29 15 Certification of OEM Devices OEM设备的认证购买 16GHTF SG3 N15R8 风险管理原则和活动在质量管理体系中的实施购买2005 5 20 17 软件确认基本原则 工业界及FDA人员指南购买2002 1 11 18EN 1041 2008 Information supplied by the manufacturer with medical devices制造商提供的器 械信息 外来文件 19EN ISO 3826 2 2008 人类血液及血液成分用塑料可折叠容器 第2部分 用于标签和说明手册上的图形符号外来文件 20 EN ISO 3826 3 2007 Plastics collapsible containers for human blood and blood components Part 3 Blood bag systems with integrated features ISO 3826 3 2006 外来文件 21 EN 285 2006 A2 2009 灭菌 蒸汽灭菌器 大型蒸汽灭菌器外来文件21 03 2010 22 EN 1639 2009 new 牙科学 牙科用医疗设备 仪器 外来文件30 04 2010 23 EN 1640 2009 new 牙科 牙科医疗设备 设备 外来文件30 04 2010 24 EN 1641 2009 new 牙科 牙科医疗器械 材料 外来文件30 04 2010 25 EN 1642 2009 new 牙科 牙科医疗设备 牙科植入物 外来文件30 04 2010 26 EN ISO 7886 3 2009 new 一次性使用无菌皮下注射器 第3部分 固定剂量免疫接种用自动报废注射器 外来文件21 03 2010 受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 序序号号 标标准准编编号号 new new 标标记记为为2010 7 72010 7 7日日 新新修修订订的的欧欧盟盟标标准准 标标准准名名称称文文件件来来源源实实施施时时间间 27 EN ISO 7886 4 2009 new 无菌皮下注射器 第4部分 带防止重复使用特性的注射器 外来文件21 03 2010 28 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process ISO 10993 1 2009 外来文件02 12 2009 29 EN ISO 10993 3 2009 Biological evaluation of medical devices Part 3 Tests for genotoxicity carcinogenicity and reproductive toxicity ISO 10993 3 2003 外来文件02 12 2009 30 EN ISO 10993 3 2009 Biological evaluation of medical devices Part 3 Tests for genotoxicity carcinogenicity and reproductive toxicity ISO 10993 3 2003 外来文件02 12 2009 31 EN ISO 10993 4 2009 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood ISO 10993 4 2002 including Amd 1 2006 外来文件 32 EN ISO 10993 5 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity ISO 10993 5 2009 外来文件 33 EN ISO 10993 6 2009 Biological evaluation of medical devices Part 6 Tests for local effects after implantation ISO 10993 6 2007 外来文件 34 EN ISO 10993 7 2008 AC 2009 new 医疗器械的生物学评价 第7部分 环氧乙烷灭菌残留量 外来文件19 02 2009 35 EN ISO 10993 9 2009 Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products ISO 10993 9 2009 外来文件 36 EN ISO 10993 10 2009 Biological evaluation of medical devices Part 10 Tests for irritation and delayed type hypersensitivity ISO 10993 10 2002 including Amd 1 2006 外来文件 37 EN ISO 10993 11 2009 Biological evaluation of medical devices Part 11 Tests for systemic toxicity ISO 10993 11 2006 外来文件 38 EN ISO 10993 12 2009 Biological evaluation of medical devices Part 12 Sample preparation and reference materials ISO 10993 12 2007 外来文件 39 EN ISO 10993 13 2009 Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices ISO 10993 13 1998 外来文件 40 EN ISO 10993 14 2009 Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics ISO 10993 14 2001 外来文件 41 EN ISO 10993 15 2009 Biological evaluation of medical devices Part 15 Identification and quantification of degradation products from metals and alloys ISO 10993 15 2000 外来文件 受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 序序号号 标标准准编编号号 new new 标标记记为为2010 7 72010 7 7日日 新新修修订订的的欧欧盟盟标标准准 标标准准名名称称文文件件来来源源实实施施时时间间 42 EN ISO 10993 16 2010 new 医疗器械的生物学评价 第16部分 降解产物与可容出物的毒物动力学研究设计 外来文件31 08 2010 43 EN ISO 10993 17 2009 Biological evaluation of medical devices Part 17 Establishment of allowable limits for leachable substances ISO 10993 17 2002 外来文件 44 EN ISO 10993 18 2009 Biological evaluation of medical devices Part 18 Chemical characterization of materials ISO 10993 18 2005 外来文件 45 EN ISO 11135 1 2007 Sterilization of health care products Ethylene oxide Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11135 1 2007 外来文件09 08 2007 48 EN ISO 11138 2 2009 Sterilization of health care products Biological indicators Part 2 Biological indicators for ethylene oxide sterilization processes ISO 11138 2 2006 外来文件02 12 2009 49 EN ISO 11138 3 2009 Sterilization of health care products Biological indicators Part 3 Biological indicators for moist heat sterilization processes ISO 11138 3 2006 外来文件02 12 2009 50 EN ISO 11140 1 2009 Sterilization of health care products Chemical indicators Part 1 General requirements ISO 11140 1 2005 外来文件02 12 2009 51 EN ISO 11140 3 2009 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 3 2007 including Cor 1 2007 外来文件02 12 2009 52 EN ISO 11197 2009Medical supply units ISO 11197 2004 外来文件02 12 2009 53 EN ISO 11607 1 2009 Packaging for terminally sterilized medical devices Part 1 Requirements for materials sterile barrier systems and packaging systems ISO 11607 1 2006 外来文件02 12 2009 54 EN ISO 11607 2 2006 Packaging for terminally sterilized medical devices Part 2 Validation requirements for forming sealing and assembly processes ISO 11607 2 2006 外来文件07 09 2006 55 EN ISO 11137 1 2006 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11137 1 2006 外来文件07 09 2006 56 EN ISO 11737 1 2006 AC 2009 Sterilization of medical devices Microbiological methods Part 1 Determination of a population of microorganisms on products ISO 11737 1 2006 外来文件 02 12 2009 57 EN ISO 11737 2 2009 new 医疗器械的灭菌 微生物法 第2部分 灭菌方法验证中进行的无菌检验 外来文件09 08 2007 58 EN 12342 1998 A1 2009 new 配合麻醉装置和通风器使用的呼吸管 外来文件21 03 2010 59 EN 13060 2004 A2 2010 new 小型蒸汽消毒器 外来文件30 09 2010 60 EN ISO 13485 2003 AC 2009 new 医疗器械 质量管理体系用于法规的要求外来文件 受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 序序号号 标标准准编编号号 new new 标标记记为为2010 7 72010 7 7日日 新新修修订订的的欧欧盟盟标标准准 标标准准名名称称文文件件来来源源实实施施时时间间 61EN 13726 1 2002Test methods for primary wound dressings Part 1 Aspects of absorbency外来文件27 03 2003 62EN 13726 1 2002 AC 2003外来文件02 12 2009 63 EN 13726 2 2002 Test methods for primary wound dressings Part 2 Moisture vapour transmission rate of permeable film dressings 外来文件27 03 2003 64EN 13727 2003 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements phase 2 step 1 外来文件30 09 2005 65EN 13867 2002 A1 2009Concentrates for haemodialysis and related therapies外来文件02 12 2009 66外来文件 67 EN ISO 14155 2 2009 new 用于人体的医疗器械的临床研究 第2部分 临床调查计划 外来文件21 03 2010 68 EN 14180 2003 A2 2009 new 医用消毒灭菌器 低温蒸汽甲醛灭菌器 要求和检测 外来文件21 03 2010 69 EN ISO 14937 2009 new 医疗器械的消毒 产品的微生物总数的估算 第3部分 微生物技术确认方法指南 外来文件30 04 2010 70 EN ISO 14971 2009 new 风险管理对医疗器械的应用 外来文件21 03 2010 71 EN ISO 16061 2009 new 与非有源外科植入物相关的仪器 一般要求 外来文件28 02 2010 72EN ISO 21649 2009 new 医用非针头式注射器 要求和试验方法 外来文件21 03 2010 73EN ISO 26782 2009 new 麻醉呼吸机外来文件 74EN 60601 2 2 2009 new 医用电气设备 第2 2部分 高频外科设备安全性专门要求外来文件 现现行行的的国国际际标标准准 受受控控标标准准清清单单 欧欧盟盟标标准准 CECE认认证证的的标标准准首首先先是是ENEN标标准准 其其次次为为ISOISO标标准准 现现行行的的国国际际标标准准 ISO 3826 2 2008 ISO 3826 3 2006 ISO 7886 3 2005 现现行行的的国国际际标标准准 ISO 7886 4 2006 ISO 10993 1 2009 ISO 10993 3 2003 ISO 10993 3 2003 ISO 10993 4 2002 ISO 10993 5 2009 ISO 10993 6 2007 ISO 10993 7 2008 ISO 10993 9 2009 ISO 10993 10 2002 ISO 10993 11 2006 ISO 10993 12 2007 ISO 10993 13 1998 ISO 10993 14 2001 ISO 10993 15 2000 现现行行的的国国际际标标准准 ISO 10993 16 2010 ISO 10993 17 2002 ISO 10993 18 2005 ISO 11135 1 2007 ISO 11138 2 2006 ISO 11138 3 2006 ISO 11140 1 2005 ISO 11140 3 2007 including Cor 1 2007 ISO 11197 2004 ISO 11607 1 2006 ISO 11607 2 2006 ISO 11137 1 2006 ISO 11737 2 2009 现现行行的的国国际际标标准准 ISO 14155 2 2003 ISO 14937 2009 ISO 14971 2007 ISO 16061 2008 ISO 21649 2006 ISO 26782 2009 IEC 60601 2 2 2009 ESO 1 First publication OJ Reference and title of the harmonised standard and reference document CEN EN 285 2006 A2 2009 EN 285 2006 A2 2009 02 12 2009 Sterilization Steam sterilizers Large sterilizers 灭菌 蒸汽灭菌器 大型蒸 汽灭菌器 CEN EN 455 1 2000 EN 455 1 2000 30 09 2005 Medical gloves for single use Part 1 Requirements and testing for freedom from holes 一次性使用的医疗手套第1 部分 防洞要求和测试英 文标准 CEN EN 455 2 2009 new EN 455 2 2009 new This is the first publication Medical gloves for single use Part 2 Requirements and testing for physical properties 一次性医疗用手套 物理性 能要求和试验 CEN EN 455 3 2006 EN 455 3 2006 09 08 2007 Medical gloves for single use Part 3 Requirements and testing for biological evaluation 一次性医疗用手套 生物评 价的要求和试验 CEN EN 455 4 2009 new EN 455 4 2009 new This is the first publication Medical gloves for single use Part 4 Requirements and testing for shelf life determination 一次性医疗用手套 货架寿 命的要求和试验测定 CEN EN 556 1 2001 EN 556 1 2001 31 07 2002 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 1 Requirements for terminally sterilized medical devices 标示无菌医疗器械的要求 第1部分 最终灭菌医疗器 械的要求 EN 556 1 2001 AC 200615 11 2006 CEN EN 556 2 2003 EN 556 2 2003 09 08 2007 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2 Requirements for aseptically processed medical devices CEN EN 794 1 1997 A2 2009 02 12 2009 Lung ventilators Part 1 Particular requirements for critical care ventilators CEN EN 794 3 1998 A2 2009 new EN 794 3 1998 A2 2009 new This is the first publication Lung ventilators Part 3 Particular requirements for emergency and transport ventilators CEN EN 980 2008 23 07 2008 Symbols for use in the labelling of medical devices CEN EN 1041 2008 19 02 2009 Information supplied by the manufacturer of medical devices CEN EN 1060 1 1995 A2 2009 new EN 1060 1 1995 A2 2009 new This is the first publication Non invasive sphygmomanometers Part 1 General requirements 非侵入式血压计 第1部分 一般要求 CEN EN 1060 2 1995 A1 2009 new EN 1060 2 1995 A1 2009 new This is the first publication Non invasive sphygmomanometers Part 2 Supplementary requirements for mechanical sphygmomanometers 非侵入式血压计 第2部分 机械血压计的补充要求 CEN EN 1060 3 1997 A2 2009 new EN 1060 3 1997 A2 2009 new This is the first publication Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems 非侵入式血压计 第3部分 电动机械血压测量系统 的补充要求 CEN EN 1060 4 2004 30 09 2005 Non invasive sphygmomanometers Part 4 Test procedures to determine the overall system accuracy of automated non invasive sphygmomanometers CEN EN 1089 3 2004 30 09 2005 Transportable gas cylinders Gas cylinder identification excluding LPG Part 3 Colour coding CEN EN 1282 2 2005 A1 2009 new EN 1282 2 2005 A1 2009 new This is the first publication Tracheostomy tubes Part 2 Paediatric tubes ISO 5366 3 2001 modified 气管造口插管 第2部分 儿 科用管 CEN EN 1422 1997 A1 2009 02 12 2009 Sterilizers for medical purposes Ethylene oxide sterilizers Requirements and test methods CEN EN 1618 1997 09 05 1998 CEN This is the first publication Catheters other than intravascular catheters Test methods for common properties CEN EN 1639 2009 new EN 1639 2009 new This is the first publication Dentistry Medical devices for dentistry Instruments 牙科学 牙科用医疗设备 仪 器 CEN EN 1640 2009 new EN 1640 2009 new This is the first publication Dentistry Medical devices for dentistry Equipment 牙科 牙科医疗设备 设 备 CEN EN 1641 2009 new EN 1641 2009 new This is the first publication Dentistry Medical devices for dentistry Materials 牙科 牙科医疗器械 材料 CEN EN 1642 2009 new EN 1642 2009 new This is the first publication Dentistry Medical devices for dentistry Dental implants 牙科 牙科医疗设备 牙科植入物 CEN EN 1707 1996 17 05 1997 Conical fittings with a 6 Luer taper for syringes needles and certain other medical equipment Lock fittings CEN EN 1782 1998 A1 2009 new EN 1782 1998 A1 2009 new This is the first publication Tracheal tubes and connectors 气管导管和连接器 CEN EN 1789 2007 23 07 2008 Medical vehicles and their equipment Road ambulances This standard still needs to be amended to take into account the requirements introduced by Directive 2007 47 EC The amended standard will be published by CEN as soon as possible Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered CEN EN 1820 2005 A1 2009 new EN 1820 2005 A1 2009 new This is the first publication Anaesthetic reservoir bags ISO 5362 2000 modified 麻醉储藏袋 CEN EN 1865 1999 14 10 2000 Specifications for stretchers and other patient handling equipment used in road ambulances CEN09 05 1998 CEN EN 1970 2000 14 11 2001 Adjustable beds for disabled persons Requirements and test methods EN 1970 2000 A1 200530 09 2005 CEN EN 1985 1998 10 08 1999 Walking aids General requirements and test methods This standard still needs to be amended to take into account the requirements introduced by Directive 2007 47 EC The amended standard will be published by CEN as soon as possible Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered CEN EN ISO 3826 2 2008EN ISO 3826 2 2008 19 02 2009 Plastics collapsible containers for human blood and blood components Part 2 Graphical symbols for use on labels and instruction leaflets ISO 3826 2 2008 人类血液及血液成分用塑 料可折叠容器 第2部分 用 于标签和说明手册上的图 形符号 CEN EN ISO 3826 3 2007 27 02 2008 Plastics collapsible containers for human blood and blood components Part 3 Blood bag systems with integrated features ISO 3826 3 2006 CEN EN ISO 4074 2002 31 07 2002 Natural latex rubber condoms Requirements and test methods ISO 4074 2002 EN ISO 4074 2002 AC 200802 12 2009 CEN EN ISO 4135 2001 31 07 2002 Anaesthetic and respiratory equipment Vocabulary ISO 4135 2001 CEN EN ISO 5356 1 2004 30 09 2005 Anaesthetic and respiratory equipment Conical connectors Part 1 Cones and sockets ISO 5356 1 2004 CEN EN ISO 5356 2 2007 09 11 2007 Anaesthetic and respiratory equipment Conical connectors Part 2 Screw threaded weight bearing connectors ISO 5356 2 2006 CEN EN ISO 5359 2008 23 07 2008 Low pressure hose assemblies for use with medical gases ISO 5359 2008 CEN EN ISO 5360 2009 02 12 2009 Anaesthetic vaporizers Agent specific filling systems ISO 5360 2006 CEN EN ISO 5366 1 2009 02 12 2009 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1 Tubes and connectors for use in adults ISO 5366 1 2000 CEN EN ISO 5840 2009 02 12 2009 Cardiovascular implants Cardiac valve prostheses ISO 5840 2005 CEN EN ISO 7197 2009 02 12 2009 Neurosurgical implants Sterile single use hydrocephalus shunts and components ISO 7197 2006 including Cor 1 2007 CEN EN ISO 7376 2009 02 12 2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation ISO 7376 2009 CEN EN ISO 7396 1 2007 09 08 2007 Medical gas pipeline systems Part 1 Pipeline systems for compressed medical gases and vacuum ISO 7396 1 2007 EN ISO 7396 1 2007 A1 2010 new 医用气体管道系统 第1部 分 压缩医疗气体和真空用 管道系统 This is the first publication EN ISO 7396 1 2007 A2 2010 new This is the first publication CEN EN ISO 7396 2 2007 09 08 2007 Medical gas pipeline systems Part 2 Anaesthetic gas scavenging disposal systems ISO 7396 2 2007 CEN EN ISO 7439 2009 02 12 2009 Copper bearing intra uterine contraceptive devices Requirements tests ISO 7439 2002 CEN EN ISO 7886 3 2009 new EN ISO 7886 3 2009 new This is the first publication Sterile hypodermic syringes for single use Part 3 Auto disable syringes for fixed dose immunization ISO 7886 3 2005 一次性使用无菌皮下注 射器 第3部分 固定剂量免 疫接种用自动报废注射器 CEN EN ISO 7886 4 2009 new EN ISO 7886 4 2009 new This is the first publication Sterile hypodermic syringes for single use Part 4 Syringes with re use prevention feature ISO 7886 4 2006 无菌皮下注射器 第4部分 带防止重复使用特性的注 射器 CEN EN ISO 8185 2009 02 12 2009 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems ISO 8185 2007 CEN EN ISO 8359 2009 02 12 2009 Oxygen concentrators for medical use Safety requirements ISO 8359 1996 CEN EN ISO 8536 4 2007 09 08 2007 Infusion equipment for medical use Part 4 Infusion sets for single use gravity feed ISO 8536 4 2007 CEN EN ISO 8835 2 2009 02 12 2009 Inhalational anaesthesia systems Part 2 Anaesthetic breathing systems ISO 8835 2 2007 CEN EN ISO 8835 3 2009 02 12 2009 Inhalational anaesthesia systems Part 3 Transfer and receiving systems of active anaesthetic gas scavenging systems ISO 8835 3 2007 CEN EN ISO 8835 4 2009 02 12 2009 Inhalational anaesthesia systems Part 4 Anaesthetic vapour delivery devices ISO 8835 4 2004 CEN EN ISO 8835 5 2009 02 12 2009 Inhalational anaesthesia systems Part 5 Anaesthetic ventilators ISO 8835 5 2004 CEN EN ISO 9170 1 2008 19 02 2009 Termina