CE技术文档清单最新-CE(中英文)
CE技术文件编写
1 CE技术文件清单
CE 技术文件的起草：
Part B （允许使用当地语言，但需要时，欧盟主管当局有权要求企业在限定 时间内翻译成指定欧盟成员国语言） • 与产品有关的质量体系的信息 • 风险管理报告 • 详细的产品描述
设计图及产品技术规范；包装条件及规格；生产过程描述；原材料和供方
• 试验、验证及评估报告
➢规则4 与受伤皮肤接触的非侵入性器械，形成机械屏障，
阻止或吸收渗出液体
I类
用于辅助治疗已伤及真皮的创伤 （真皮的敷料） IIb类
其他情况，包括处理创伤周围环境的
IIa 类
2.1 主要技术文件-产品分类
侵入性器械（规则 5）
➢规则5 侵入人体自然孔径的医疗器械
暂时使用 （如检查手套、牙科压缩材料） I类
创伤性：非创伤 通过孔径插入 外科创伤 植入
适用位置：中央循环系统 （包括 所有大动脉）；中央神经系统；人 体孔径；其他地方
能量供应： 无源 ； 有源
分类规则（附录IX）
非创伤医疗器械的分类 规则1～4
创伤性医疗器械的分类 规则5～8
有源医疗器械附加分类规则，对于
单独使用的软件产品应视为有源医
疗器械
IIa类
• 诊断/监视体内放射药物分布（r照相机、正电子发射成像仪） IIa类
• 危险情况下监视生理功能（手术中的血气分析仪）
IIb类
• 发出电离辐射（X射线诊断仪）
IIb类
2.1 主要技术文件-产品分类
有源器械
规则11 控制药物或其他物质进出人体的有源器械
（如吸收设备、供给泵） 以一种潜在危险方式工作的 （麻醉机、呼吸机、透析机、高压氧舱）
非侵入性器械（规则 1～4）
CE技术文件(详细)(可编辑修改word版)
预期用途描述
Description of intended use
具体使用在哪，此项也可包含在产品总体描述中。
3.
产品等级划分，所选分类规则、理由
Class of device, chosen classification rule and justification
根据医疗器械指令附录9中内容规则1-规则18判断产品等级。
11
风险分析
Riskanalysis
企业需注明产品有什么风险并是怎么降低和消除风险，需要提交相关风险分析报告书
21. 软件有效性报告：（PVC）电路板
22.PMS：销售产品相关的骨科满意度、不良追踪报告等。
7.
计划制造方法
Planned production methods
具体到产品生产、检验的整个过程。包括作用指导书及体系的文件。
8.
制造过程各阶段及最终的检验测试
Description of checks during and at the end of production
企业内部的测试。由公司内部具有审核员资格的人员或者专业人士进行的测试
同药物一同使用的部品。这类产品一般属于三类产品。按照指令修改内容，产品需要满足EMEA认证。
6.
所用动物组织描述(如适用)
Description of utilized tissues of animal origin (if applicable)
普通动物组织：需提交原料来源安全证明资料。
可能诱导疯牛病的产品：则不适用2003/32/EC指令。必须对其进行安全性的证明，有可能诱发疯牛病的动物包括牛、羊等。需要在欧盟有单独的认证机构通过EDQM认证进行符合性评价。
CE中英文
COUNCIL DIRECTIVE 93/42/EECof 14 June 19931993年6月14日理事会第93/42/EEC号指令concerning medical devices关于医疗器械THE COUNCIL OF THE EUROPEAN COMMUNITIES,欧洲共同体理事会Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, 依据欧洲经济体所制订的罗马条约, 特别是第100a条规定Having regard to the proposal from the Commission依据执委会的建议案In cooperation with the European Parliament配合欧洲议会Having regard to the opinion of the Economic and Social Committee,依据经济暨社会委员会的意见Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;鉴于内部市场的完成应采取一些措施; 鉴于内部市场是一无内部疆界的区域, 区域内的货物, 人员, 服务及资金应可自由流通Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;鉴于各会员国间现存有关医疗器械的安全, 对健康的保护及使用特性方面的法律, 法规及行政命令的内容与范围不尽相同; 鉴于各会员国对此器械的验证及检验程序也不相同; 鉴于前述的分歧将阻碍共同体内的贸易活动;Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal markert;鉴于医疗器械的使用对病患, 使用者, 甚至其他人有关安全及健康保护的相关国家规定应加以调和, 以保证此类器械在内部市场能自由流通;Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;鉴于调和的规定必然与各会员国采取的部分措施有所不同, 这些措施是为筹措公共健康与疾病保险计划的基金, 且直接或间接与医疗器械有关; 鉴于共同体若与上述措施相符, 则这些规定并不影响会员国落实上述措施的能力;Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;鉴于医疗器械应提供病患, 使用者及第三者高度的保护, 且应该达到厂商所要求的性能水准; 鉴于维持或改进各会员国对病患等保护的程度乃本指令目的的一;Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;鉴于部分医疗器械是符合1965年1月26日理事会第65/65/EEC号指令, 与专卖医药产品有关的法律, 法规或管理行为所订的实施规定, 鉴于医疗器械的上市基本上由本指令规范, 但医疗产品的上市则受65/65/EEC号指令规范; 鉴于若有某种器械须与其他医疗产品组成一完整的产品而上市销售, 使用, 且无法二次使用时, 则该组合产品应受65/65/EEC 号指令规范; 鉴于前述的医疗器械和包含医疗物质且该物质单独使用时符合65/65/EEC号指令规定的医疗器械应加以区别; 鉴于前述包含于医疗器械的医疗物质若对人体产生作用以辅助医疗器械的作用时, 则该医疗器械的上市应由本指令规范; 鉴于1975年5月20日75/318/EEC号理事会指令[制定各会员国在测试专利医疗产品方面有关分析药物毒性和临床的标准及调查书的法律调和], 医疗物质的安全, 品质及效用在前述情况下则须依该指令明定的适当方法加以证实;Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;鉴于本指令附录所订的基本要求及其他要求, 包括[最低]或[降低]危险部分的应用, 应考虑设计当时的科技及实施情形, 并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions;鉴于为符合1985年5月7日理事会决议中有关技术调和与标准化新方针所订定的原则, 有关医疗器械的设计及执照应遵守相关条款以符合基本要求; 鉴于这些要求属基本要求, 所以应取代对应的国家规定;whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;鉴于基本要求的落实应谨慎考虑设计当时的科技水准, 并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;鉴于1990年6月20日通过的90/385/EEC号[各会员国有关主动植入式医疗器械法律调和] 的理事会指令是第一个应用在医疗器械方面的新方法指令; 鉴于为使共同体规定适用于所有的医疗器械, 本指令基本上是以90/385/EEC号指令的条款为依据; 鉴于90/385/EEC号指令,因此也必须增加本指令所列的一般条款的部分;Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility;鉴于医疗器械的电磁相容性是整个产品安全的一部分; 鉴于本指令因此须包括1989年5月3日89/336/EEC号[各会员国有关电磁相容性法律调和]的理事会指令中所制订的特定规定;Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment; whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and the specific directives on the same subject should continue to apply;鉴于本指令应包含释放电离辐射医疗器械设计及制造的相关要求; 鉴于本指令不影响1980年7月15日80/836/Euratom 理事会指令所需要的授权, 该指令目的在修订为保护大众及工作人员健康, 防止电离辐射危险而制订基本安全标准的其他指令; 本指令亦不影响1984年9月3日84/466/Euratom号[制订保护人员在医疗检查或治疗中不受辐射影响的基本方法] 理事会指令的适用; 鉴于1989年6月12日89/391/EEC号理事会指令[鼓励改善工作场所中工人的安全与健康]及其他相关主题的指令应持续适用;Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;鉴于为证明符合基本要求并使该符合性得以落实, 有必要建立调和的欧洲标准, 以避免医疗器械在设计, 制造及包装上所可能带来的危险, 鉴于调和的欧洲标准由私人立法机构制订, 而且应维持自愿性质; 鉴于欧洲标准化委员会(CEN) 及欧洲电工标准化委员会(CENELEC) 被认为是制订调和标准有能力的团体(competent bodies),而此标准符合1984年11月13日执委会与上述两团体所签订的合作纲要为基础的一般指导原则;Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC; whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;鉴于为达本指令目的, 调和标准是前述机构接获理事会命令后, 依理事会1983年3月28日通过的83/189/EEC号指令[有关制订技术标准及法规资讯提供的程序]而采纳的技术规范(欧洲标准或调和文件, 符合前述一般纲要的规定 ; 鉴于调和标准的修正有赖于83/189/EE号指令建立的委员会的协助; 鉴于应采取的措施须依照理事会87/378/EEC号指令程序一的规定; 鉴于特殊领域中现存的欧洲药典专题论文应纳入本指令的架构中; 因此数篇欧洲药典专题论文将视其与前述调和标准有着同等的效力;Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives, the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;鉴于理事会在1990年12月13日通过的90/683/EEC号[有关技术调和指令适用的符合评鉴程序各阶段模式]决定中制定调和的符合评鉴程序; 鉴于这些模式于医疗器械的应用, 可以依相关器械的型式决定制造商及公告机构在符合评鉴程序中应负的责任; 鉴于医疗器械的证明有必要在模式里增加细节的规定;Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;鉴于为达到符合评鉴的目的有必要将医疗器械分为四类; 鉴于分类是以考虑器械的技术设计及制造对易受伤的人体可能带来的危险程度为原则; 鉴于第I类医疗器械对人体可能产生的伤害较轻微, 其符合性评鉴程序大致可由制造商完全负责执行; 鉴于对第II(a)类医疗器械而言, 在生产阶段时公告机构的介入应属强制性质; 鉴于属于第II(b)类及第III类的医疗器械对人体具有较高的潜在危险, 因此在器械的设计及制造阶段必须有公告机构的检验; 鉴于第III类的器械皆为较特别的器械, 其一致性需在上市的前获得明确授权;Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;鉴于器械的一致性如能由制造商负责评鉴, 相关主管机关, 特别是紧急状况时, 应能联络到一位设于共同体内负责将器械在市场上销售的人员, 该人员可以是制造商本人或其他设于共同体内经制造商授权的人员;Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;鉴于医疗器械应附加CE标志, 表示其符合本指令的条款, 而得以在共同体市场上自由流通并依其设计的目的使用;Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level, medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;鉴于为抵抗爱滋病, 并顾及理事会于1989年5月16日采纳有关共同体层次未来防止暨控制爱滋病相关活动的结论, 用于防止HIV病毒感染的医疗器械应提供人体高度的保护; 此类产品的设计及制造应由公告机构的证实;Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves;whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC;鉴于前述的分类原则大多可以适当地将医疗器械分类; 鉴于医疗器械性质及相关领域技术进步的性质各异, 因此必须采取一些措施以决定授予执委会的执行权力及有关器械的分类或再分类, 或者于适当时调整分类的原则; 鉴于上述的问题与人员健康的保护有着密切的关联, 因此这些决议应依照87/373/EEC号指令程序IIIa规定;Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;鉴于制造商有责任执行临床调查以证明其医疗器械符合安全要求; 因此为保证大众健康及秩序应明订执行临床调查的适当方法;Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;鉴于健康的保护及相关的管制方法以在共同体层次上建立一个医疗装置警戒系统为最有效;Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers; whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine must be amended,鉴于理事会于1976年7月27日通过76/764/EEC号[有关各会员国水银玻璃最高温度计法律调和] 的指令中所提及的医疗器械亦受本指令规范; 前述指令因此必须撤销;基于同样原因, 理事会1984年9月17日通过的84/539/EEC号指令[有关各会员国人类或动物医疗使用的电动医疗器械法律调和],HAS ADOPTED THIS DlRECTIVE:爰制订本指令:Article 1第 1 条Definitions, scope定义, 范围1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive,accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.本指令适用于医疗器械及其附属物. 附属物在本指令的适用范围内亦视其为医疗器械. 两者以下皆称器械.2. For the purposes of this Directive, the following definitions shall apply:为本指令的目地, 下列定义适用于:(a) medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or incombination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:[医疗器械]是指制造商设计供人类于下列情况, 不论是单独或合并使用的仪器, 设备, 器械, 材料或其他物品, 包括适当应用所需的软体, 而此种应用是厂商为人们下列的目地而订定:- diagnosis, prevention, monitoring, treatment or alleviation of disease,诊断, 预防, 追踪, 治疗或减轻疾病,- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,诊断, 追踪, 治疗或修整伤处或残障部位,- investigation, replacement or modification of the anatomy or of a physiological process,解剖或生理过程中的检查, 换置或修正,- control of conception,生育控制,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;这些器械不可借药性, 免疫力或新陈代谢的方法在人体内达到其主要设计的目的, 但可用这些器械辅助其功能者;(b) 'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to beused together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;[附属物]是指本身不可独立使用的器械, 制造商设计附属件的目地是配合其他器械合并使用, 使该器械得以依其设计目地发生功用;(c) 'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument,equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;[体外诊断用器械] 是指任何自成单位或与其他物件组合的任何试剂, 试剂品, 套装用具, 仪器, 设备或系统形态的器械. 这种器械是制造商设计作为检查人体组织标本用的器械, 以期能够提供有关其生理状况, 健康或生病或任何先天不正常等讯息;(d) 'custom-made device' means any device specifically made in accordance with a duly qualified medicalpractitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.[订制的器械] 是指依照合格医疗从业人员描述的特色而特别制作的器械, 该器械是为特定病患设计且专供该病患使用.The above mentioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.前述的描述可以由专业资格而获授权的其他人提供.Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or. any other professional user are not considered to be custom-made devices;但订制的器械不包括那些为满足医疗人员或其他专业使用人要求而改装且大量生产的器械 .(e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medicalpractitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.[临床调查用的器械]是指由适当的合格医疗从医人员在适当的人类临床环境中, 执行附录十第2.1.所述的调查时所使用的任何器械.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;其他具专业资格的人员经授权执行此种临床调查将视同合格医疗从事人员所执行的临床调查;(f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging andlabelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.[制造商]是指器械以其名称上市前, 负责器械的设计, 制造, 包装及贴附标签的自然人或法人, 无论这些设计, 制造等过程是否为自然人或法人亲自执行或委托第三者执行.The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, full refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;本指令所规定有关制造商的责任亦适用于将一个或一个以上现成的产品加以组装, 包装, 加工, 重新处理及 / 或附加标签而成一器械, 指定其用途并准备以其名称命名上市的自然人或法人. 对于那些非属前一段制造商定义者, 为个别病患的需要拼装或改装已上市销售的器械的情形不适用本段的规定;(g) 'intended purpose' means the use for which the device is intended according to the data supplied by themanufacturer on the labelling, in the instructions and/or in promotional materials;[预期的用途]是指器械须依照制造商于标签上, 说明书及/ 或促销宣称中提供的使用条件及资料;(h) 'placing on the market' means the first making available in return for payment or free of charge of a device otherthan a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;[上市]是指为大量行销及 / 或于共同体市场使用的目的, 首次以金钱交易或免费赠送方式提供非临床调查用全新或重新处理过的器械的行为;(i) 'putting into service' means the stage at which a device is ready for use on the Community market for the firsttime for its intended purpose.[开始使用]是指某一器械在共同体市场首次可依原订的用途开始使用的时期.3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive' 65/65/EEC with regard to the medicinal product.对于用来管理65/65/EEC号指令第一条定义的医疗产品的器械, 在不侵害65/65/EEC号有关医疗产品指令条款的规定下, 该类器械应受本指令规范.If, however, such a device is placed on the market in such a way that the device and the medicinal product forma single integral product which is intended exclusively for use in the given combination and which is not reusable,that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.但是, 假若某种器械须与其他医疗产品组合成一完整的产品而上市销售使用, 且无法二次使用时, 该组合产品应受65/65/EEC号指令规范. 本指令附录一所列有关器械安全及性能方面的相关基本要求仍然适用.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered tobe a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.如果医疗器械包含某项医疗物质, 而该物质单独使用时符合65/65/EEC号指令第一条对医疗产品的定义, 且可能对人体产生作用以辅助医疗器械的作用时, 该器械应依照本指令的规定加以评鉴并授权.5. This Directive does not apply to:本指令不适用于下列器械:(a) in vitro diagnostic devices;体外诊断器械;(b) active implantable devices covered by Directive 90/385/EEC;受90/385/EEC号指令规范的主动植入式医疗器械;(c) medicinal products covered by Directive 65/65/EEC;受65/65/EEC号指令规范的医疗产品(d) cosmetic products covered by Directive 76/768/EEC;受76/768/EEC号指令规范的化妆品;(e) human blood, human blood products, human plasma or blood cells of human origin or to devices whichincorporate at the time of placing on the market such blood products, plasma or cells;人类的血液, 血液产品, 血浆或血球, 或者上市时包含人类血液产品, 血浆或血球的器械;(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells ofhuman origin;人类的移植器官, 组织或细胞及包含或由人类组织, 细胞产生的产品;(g) transplants or tissues or cells of animal origin, unless device is manufactured utilizing animal tissue which isrendered non-viable or non-viable products derived from animal tissue.动物的移植器官, 组织或细胞; 但利用死的动物组织或其产品而制造的器械则不在此限.6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In decidingwhether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product.本指令不包括受89/686/EEC号指令规范的个人保护装备. 而要决定某产品应受该指令规范亦受本指令规范时, 必须特别考虑该产品设计的主要目的.7. This Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336/EEC.本指令是89/336/EEC号指令第二条第2项中所述的特定指令.8. This Directive does not affect the application of Directive 80/836/Euratom, nor of Directive 84/466/Euratom.本指令不影响80/836/Euratom指令及84/466/Euratom 指令的实施.Article 2第 2 条Placing on the market and putting into service上市及使用Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.各会员国必须采取所有必要的措施, 以确保器械依其设计的目的安装, 维护及使用时不会牺牲病患, 使用者或, 适用时, 其他人员的安全及健康后方可上市.Article 3第 3 条Essential requirements基本要求The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.器械依其设计的目的必须符合附录一所列适用的基本要求, 并顾及器械原先预期的用途.Article 4第 4 条Free movement, devices intended for special purposes自由流通及特殊目的的器械1. Member States shall not create any obstacle to the placing on the market or the putting into service within theirterritory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.各会员国在其领土内不得对附加第十七条所述CE标示器械的上市及使用设立任何障碍, CE 标示代表该器械已依第十一条的规定经过符合评鉴的程序.2. Member States shall not create any obstacle to:对于下列器械会员国不得设有任何障碍:- devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,符合第十五条及附录八规定, 供医疗从业人员或经授权的人员执行临床调查而制造的器械- custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII.符合第十一条及附录八规定上市及使用的订制器械; 属于第IIa, IIb, 及III类器械须附有附录八所提的说明资料.These devices shall not bear the CE marking.上述器械无需附加CE标示.3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing ofdevices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.对于未符合本指令的器械, 但有明显的标识说明该器械在未符合本指令的规定前不可上市销售或使用时, 各会员国不得妨碍其于商展中展示.4. Member States may require the information, which must be made available to the user and the patient inaccordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.会员国得要求专业或非专业用途的医疗器械, 其依附录一第13点规定供使用者及病患使用的相关资讯必须以该国语言或其他共同体语言书写.5. Where the devices are subject to other Directives concerning other aspects and which also provide for theaffixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other Directives.若某器械在其他方面亦受到其他指令的规范, 且该等指令同时包含CE标示附加的说明, 则其CE标示表示该器械亦符合其他指令的条款.However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices.。
(完整版)CE认证的全套技术文件
CE文件清单拟制日期2014年5月17日审核日期2014年5月17日批准日期2014年5月17日版号A生效日期2014年8月1日XX有限公司CE技术文件清单企业简介拟制日期2014年5月17日审核日期2014年5月17日批准日期2014年5月17日版号A生效日期2014年8月1日XX有限公司企业概况关于欧洲代表声明拟制日期2014年5月17日审核日期2014年5月17日批准日期2014年5月17日版号A生效日期2014年8月1日XX有限公司关于确定欧洲代表的声明本公司欧洲代表是XX,地址：XXX联系方式：XXX特此确定声明!职位签名日期产品描述拟制******日期2014年5月17日审核******日期2014年5月17日批准******日期2014年5月17日版号A生效日期2014年8月1日XX有限公司产品描述一、产品性能特性:“”（商品名:）是由有限公司根据市场和临床治疗的需要, 产品中以无机生物活性材料为主要原料而研发生产的XXX医疗产品。
当XXX产品与创面组织接触时，其中具有生物活性的无机生物活性材料与组织发生离子交换，提高创面局部的氧分压和PH值，在表面形成较强的负电势，并通过一系列生化反应，形成一个羟基磷灰石（HCA组成的多孔网状结果组织，能吸附大量与组织再生有关的各种物质，使新生组织得以顺利爬移。
从而达到加速创面愈合的作用。
二、产品适用范围：“****** ”（商品名:******）适用与各种手术及外伤造成的创面，皮肤溃疡及褥疮以及浅H度烧、烫伤的创面愈合。
三、产品主要技术性能及参数：1、产品命名：1．1 产品通用名：******1．2 产品商品名：******2、产品成份：2．1 粉状产品由组成2、2 膏状产品由组成3、产品形式与规格：3．1 产品形式：膏状、粉状3．2产品规格:1）粉状：2) 膏状：,3) 4、主要技术性能及参数：4、1产品外观：粉状产品为。
膏状产品为。
4、2产品装量：粉状产品装量应符合下表规定膏状产品装量应符合下表规定4、3粒度：粉状产品：。
(完整word版)无源医疗器械CE技术文档和CE设计档案材料指南(中英文 也是极好的)
无源医疗器械技术文件和设计文档指南Whereas the term “Technical File“ is used for Medical Devices of class I, class IIa and class IIb, the term “Design Dossier“ is used for the class III products.标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类医疗器械。
Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body.Part B of the Technical File may be available at the manufacturer only.技术文件是保留在制造商或授权代表单位的主管部门和认证机构。
部分技术文件B部分只保留在制造商处。
Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE-Marking of the product (use form Application for CE Conformity Assessment (Product)MED_F_03.03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. After successful review, the Notified Body issues a design examination certificate according to Annex II.4 of the Council Directive certifying compliance with the relevant provisions of Annex I of the MDD.设计档案材料已被提交到公告机构用于需要CE认证前的产品审查（用CE合格评定（产品）MED_F_03.03规定的格式）。
无源医疗器械CE技术文档和CE设计档案材料指南(中英文 也是极好的)
无源医疗器械技术文件和设计文档指南Whereas the term “Technical File“ is used for Medical Devices of class I, class IIa and class IIb, the term “Design Dossier“ is used for the class III products.标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类医疗器械。
Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body.Part B of the Technical File may be available at the manufacturer only.技术文件是保留在制造商或授权代表单位的主管部门和认证机构。
部分技术文件B部分只保留在制造商处。
Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE-Marking of the product (use form Application for CE Conformity Assessment (Product)MED_F_03.03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. After successful review, the Notified Body issues a design examination certificate according to Annex II.4 of the Council Directive certifying compliance with the relevant provisions of Annex I of the MDD.设计档案材料已被提交到公告机构用于需要CE认证前的产品审查（用CE合格评定（产品）MED_F_03.03规定的格式）。
CE技术文档
CE技术文件中至少应包含如下内容（有源产品适用）1.封面（如下例，仅供参考）2.目录（可根据自己的文件安排）3.文件更新记录表(如下例，仅供参考)Revision History Sheet4.制造商地址（如公司地址和制造场地地址不同，要写清楚每个地址，如果是经销商，只写明注册地址即可）5.欧盟授权代表（须附与欧盟授权代表签的协议）6.DoC Declaration of Conformity 符合性声明（例，样本见附录1）7.产品名录，产品图片，宣传单等（如有，并请注意宣传册最好加版本号）8.产品/产品族的常规描述8.1产品简介用描述的方式介绍产品或产品族的主要功能，简要的基本工作原理等。
8.2预期用途使用的目的，人群，地点环境等,可参考其它公司同类产品的预期用途来定义8.3产品基本设计实现描述本产品简要的设计原理，可按硬件功能框图或原理框图来稍加描述。
如果是系列产品要说清楚产品族中每个产品之间的相同和不同点。
可列表比较说明。
8.4性能规格（可参照公司的企业标准的技术指标部分，若是系列产品要在指标中体现清楚差异）8.5附件清单表（例如各种配用的探头附件的型号及数量，按产品实际的标配及选配附件填写）8.6分类规则According to 93/42/EEC Annex IX, Rules XX, (产品名) is a class XX device.如一个产品族中分类等级不同要按不同规则来分类8.7认证途径选择Directive MDD93/42/EEC Annex XX，要根据分类的等级来选择合适的认证途径9.适用的产品标准清单列表（例，如下，适用标准应不仅限于上述这些，还应根据本公司具体的产品要求增加需符合的其它欧盟协调标准）需要标列出标准的版本，需为最新版本International Standard & Harmonized European Standard List10.BOM清单产品的材料清单列表，提供可链接到的文件名和文件编号即可。
CE主文档清单
CE技術主文檔3. technical information3.1 General●Content of technical documentation技术文件目录●Other3.2product description產品描述● A general description of the device器械的总体描述● A description of the intended use and operation of the device预期用途和操作说明●Device incorporating a medicinal substance●Device incorporating nonviable materials of animal origin●Device requiring special consideration需特殊考虑的器械●Description of the methods of manufacture envisaged制造方法描述●Description of the accessories, adaptors and other of equipment and otherinterfaced which are intended by the manufacturer to be used in combinationwith the device配件、适配器和其它关联设备●Classification of the device under the relevant directive分类规则3.3 technical requirements技術要求●Identification of technical requirements技術要求識別●Solutions adopted to fulfill the essential requirements基本要求檢查表●Standards applied適用標準3.4design設計●The results of the risk analysis風險分析●Specification of materials and manufacturing/special processing物料規格和製程/特殊過程●Specifications drawings and circuit diagrams for components sub-assemblies andthe complete product including packaging, there appropriate規格圖紙、組件裝配電路圖，包括包装的最终产品●The specifications of the checks, tests and trials that are intended to be carriedout as part of routine production检验规范，日常生产的检验和测试●The performances and compatibilities intended by the manufacturer制造商的预期使用要求●Labeling, including any instructions for use标签，使用说明书●Identification of …”shelf-life” reflected by any “use by ”date, or other “lifetime‟of the device保质期/产品寿命●Results of bench testing實驗室測試結果●Clinical data臨床資料●Documentation and reporting of design changes設計變更文件和報告3.5 administrative details管理細節●Declaration of conformity符合性聲明●Application for conformity assessment合格評定申請●Declaration that no other notified body is used in conformity assessment在合格評定中沒有使用其他公告機構的聲明●Notified body decisions and reports公告機構●Manufacture‟s undertaking on procedure to review post-pro-diction experiencePART A1．The name and address or the “manufacturer” within the meaning of the directive.製造商名稱和地址2．Identification of the device covered by the “summary” documentation.所涵盖器械的識別的“纪要”的文件3．The name and address of the facilities工廠的名称和地址。
CE认证中英文介绍
1 前言Introduction欧洲议会和欧洲理事会于2006年5月17日正式通过了，产品申请CE认证(CE-Marking即CE标志)的最新版机械指导法令(2006/42/EC)，此法令是欧盟按照新方法(New approach)制定的有关健康、安全的基本法令之一。
与现行机械指令98/37/EC相比，新指令在适用范围、与其他指导法令的界线、市场临督、安全性零组件、合格评定程序以及基本健康和安全要求等方而都出现了一些新要求和明显的变化。
European Parliament and European Council have adopted the latest version of the Machinery Directive (2006/42/CE) on 17 May, 2006. This new directive is made according to a new approach; its one of the basic directives on health and safety concern. Compared with the present Machinery Directive 98/37/EC there are some new requirements and noticeable changes to the new one on its application, boundary with other directives, market supervision, safe components, conformity assessment procedure, the requirement for the basic health and safety, etc.面对新的技术壁垒，相关部门和广大企业应提前做好研究，有关欧盟对CE认证(CE-Marking)的新规定,及早从实际应用和技术角度出发加以积极应对。
(完整word版)无源医疗器械CE技术文档和CE设计档案材料指南(中英文也是极好的)
无源医疗器械技术文件和设计文档指南Whereas the term “Technical File“ is used for Medical Devices of class I，class IIaand class IIb，the term “Design Dossier“ is used for the class III products.标题中的“技术文件”适用于I类，IIa类，IIb类医疗器械，“设计文档”适用于III类医疗器械. Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body.Part B of the Technical File may be available at the manufacturer only.技术文件是保留在制造商或授权代表单位的主管部门和认证机构。
部分技术文件B部分只保留在制造商处。
Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE—Marking of the product (use form Application for CE Conformity Assessment (Product）MED_F_03。
03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. After successful review，the Notified Body issues a design examination certificate according to Annex II。
CE 认证的全套技术文件(新)
XXXX有限公司CE技术文件清单文件编号：AMS/CE,JS-2015版次号：A/0受控状态：受控分发编号：发布日期：2014年8月1日生效日期：2013年08月15日XXXX有限公司发布受控状态AMS/公司简介企业概况受控状态AMS/关于欧洲代表声明关于确定欧洲代表的声明本公司目前无产品销售到欧洲地区，也无确定欧洲代表，今后在产品出口欧洲之前确定好欧洲商及欧洲代表地址等，然后通知认证公告机构。
职位签名日期受控状态AMS/产品描述一、产品性能特性:“”(商品名:)是由有限公司根据市场和临床治疗的需要,产品中以无机生物活性材料为主要原料而研发生产的促进创面修复的医疗产品。
当“”产品与创面组织接触时，其中具有生物活性的无机生物活性材料与组织发生离子交换，提高创面局部的氧分压和PH值，在表面形成较强的负电势，并通过一系列生化反应，形成一个羟基磷灰石（HCA）组成的多孔网状结果组织，能吸附大量与组织再生有关的各种物质，使新生组织得以顺利爬移。
从而达到加速创面愈合的作用。
二、产品适用范围：“******”(商品名:******)适用与各种手术及外伤造成的创面，皮肤溃疡及褥疮以及浅Ⅱ度烧、烫伤的创面愈合。
三、产品主要技术性能及参数：1、产品命名：1．1产品通用名：******1．2产品商品名：******2、产品成份：2．1粉状产品由组成2、2膏状产品由组成3、产品形式与规格：3．1产品形式：膏状、粉状3．2产品规格:1）粉状：2）膏状：，3）4、主要技术性能及参数:4、1产品外观:粉状产品为。
膏状产品为。
4、2产品装量:粉状产品装量应符合下表规定膏状产品装量应符合下表规定4、3粒度:粉状产品：。
膏状产品：。
4、4重金属含量:产品重金属的含量不大于30mg/Kg。
4、5炽灼残渣:粉状产品炽灼残渣≥90﹪(W/W)。
膏状产品炽灼残渣≥20﹪(W/W)。
4、6生物活性:4、7无菌：本产品应无菌。
4、8细胞毒性试验：细胞毒性应≤1级。
CE技术文档的介绍与主要内容
STEP 02
标题与段落
文档应具有清晰的目录结 构和层次，方便读者快速 找到所需内容。
STEP 03
列表与表格
适当使用列表和表格来呈 现信息，提高文档的可读 性。
每个段落应有明确的标题， 以便读者能够快速理解段 落内容。
图片与图表要求
高质量图片
确保图片清晰、色彩准确，以增强文档的可读 性。
保障产品品质和安
全
CE技术文档的编写和审核过程严 格遵循相关标准和规范，确保产 品或系统的品质和安全性，降低 潜在的风险和问题。
CE技术文档的应用场景
产品研发阶段
在产品研发阶段，CE技术文档用于描述产品 的技术特性和规格，为开发、测试团队提供 参考和依据。
销售支持
销售人员可以利用CE技术文档向潜在客户介绍产品 的技术特点和优势，提高销售效果。
图表说明
对每个图表进行详细的说明，解释图表中的数 据和意义。
图示与流程图
使用图示和流程图来解释复杂的概念或过程，帮助读者更好地理解。
Part
04
CE技术文档的审查与批准
审查流程
文档提交
编写完成的CE技术文档需提交给 审查委员会。
修改与完善
根据审查委员会的意见和建议， 对CE技术文档进行修改和完善。
负责组织编写CE技术文档，协调 各方资源，确保文档按时提交审 查。
负责主持审查会议，协调各方意 见，做出最终批准或不批准的决 定。
Part
05
CE技术文档的更新与维护
更新周期
季度更新
01
每季度对CE技术文档进行一次全面更新，确保文档内容与当前
技术发展保持同步。
紧急修复
02
针对重大技术问题或安全漏洞，及时发布紧急修复更新，保障
（完整word版）ECE系列标准清单
（完整word版）ECE系列标准清单ECE系列标准序号代号法规名称1 ECE R1 关于批准发射不对称近光和/或远光并装有R2/或HS1类灯丝灯泡的机动车前照灯的统一规定2 ECE R2 关于批准发射不对称近光和/或远光的前照灯用白炽电灯泡的统一规定3 ECE R3 关于批准机动车辆及其挂车回复反射装置的统一规定4 ECE R4 关于批准机动车辆(摩托车除外)及其挂车后牌照板照明装置的统一规定5 ECE R5 关于批准发射欧洲型不对称近光和/或远光机动车封闭式前照灯(SB) 的统一规定6 ECE R6 关于批准机动车及其挂车转向指示器的统一规定7 ECE R7 关于批准机动车（不含摩托车）及其挂车前后位置（侧边）灯、制动灯和示廓灯的统一规定8 ECE R8 关于批准发射不对称近光和/或远光并装有卤素灯丝灯泡（H1、H2、H3、HB3、HB4、H7、H8、H9、HIR1、HIR2和/或H11）的机动车前照灯的统一规定9 ECE R9 关于就噪声方面批准L2、L4和L5类车辆的统一规定10 ECE R10 关于就电磁兼容性方面批准车辆的统一规定11 ECE R11 关于就门锁和车门保持件方面批准车辆的统一规定12 ECE R12 关于就碰撞中防止转向机构伤害驾驶员方面批准车辆的统一规定13 ECE R13 关于就制动方面批准M类、N类和O类车辆的统一规定14 ECE R13--H 关于就制动方面批准乘用车的统一规定（欧美日协调版）15 ECE R14 关于就安全带固定点方面批准车辆的统一规定16 ECE R15 关于就发动机气体污染物排放方面批准装有点火式发动机或压燃式发动机的车辆的统一规定--点火式发动机的功率测量方法---车辆的油耗测量方法17 ECE R16 关于：1批准机动车成年乘客用安全带和约束系统；2批准装用安全带的车辆的统一规定18 ECE R17 关于就座椅、座椅固定点和头枕方面批准车辆的统一规定19 ECE R18 关于就防盗方面批准机动车的统一规定20 ECE R19 关于批准机动车前雾灯的统一规定21 ECE R20 关于批准发射非对称近光和/或远光并装有卤素灯丝灯泡（H4）的机动车前照灯的统一规定22 ECE R21 关于就内饰件方面批准车辆的统一规定23 ECE R22 关于批准摩托车轻便摩托车驾驶员及乘客用头盔和面罩的统一规定24 ECE R23 关于批准机动车辆及其挂车的倒车灯的统一规定25 ECE R24 关于1.就可见污染物排放方面批准压燃式(C.I)发动机;2.就已获得型式批准的C.I.发动机的安装方面批准机动车; 3. 就发动机可见污染物排放方面批准装用C.I.发动机的车辆; 4 .C.I.发动机的功率测量的统一规定26 ECE R25 关于批准与车辆座椅一体或非一体的头枕的统一规定27 ECE R26 关于就外部凸出物方面批准车辆的统一规定28 ECE R27 关于批准提前三角警告牌的统一规定29 ECE R28 关于就声响信号方面批准声报警装置和机动车辆的统一规定30 ECE R29 关于就商用车辆驾驶室乘员防护方面批准车辆的统一规定31 ECE R30 关于批准机动车及其挂车气压轮胎的统一规定32 ECE R31 关于批准发射非对称近光和/或远光的卤素封闭式（HSB）机动车前照灯的统一规定33 ECE R32 关于就追尾碰撞中被撞车辆的结构特性方面批准车辆的统一规定34 ECE R33 关于就正面冲撞中被撞的结构特性方面批准车辆的统一规定35 ECE R34 关于就火灾预防方面批准车辆的统一规定36 ECE R35 关于就脚控制件的布置方面批准车辆的统一规定37 ECE R36 关于就一般结构方面批准大型客车的统一规定38 ECE R37 关于批准用于已经批准的机动车和挂车灯具中的白炽灯的统一规定39 ECE R38 关于批准机动车和挂车后雾灯的统一规定40 ECE R39 关于就车速表及其安装方面批准车辆的统一规定41 ECE R40 关于就发动机气体污染物的排放方面批准装有点火式发动机的摩托车的统一规定42 ECE R41 关于就噪声方面批准摩托车的统一规定43 ECE R42 关于就车辆前、后保护装置（保险杠等）批准车辆的统一规定44 ECE R43 关于批准安全玻璃材料的统一规定45 ECE R44 关于批准机动车儿童乘客约束装置（儿童约束系统）的统一规定46 ECE R45 关于就前照灯清洗器方面批准机动车辆和批准前照灯清洗器的统一规定47 ECE R46 关于批准后视镜和就后视镜的安装方面批准机动车辆的统一规定48 ECE R47 关于就发动机的气体污染物排放方面批准装有点火发动机的轻便摩托车的统一规定49 ECE R48 关于就灯光和光信号装置的安装方面批准车辆的统一规定50 ECE R49 关于就发动机污染物排放方面批准压燃式发动机、天然气发动机和燃用液化石油气的点燃式发动机以及装有这些发动机的车辆的统一规定51 ECE R50 关于批准轻便摩托车、摩托车及其类似车辆前后位置灯、制动灯、转向信号灯和后牌照板照明装置的统一规定52 ECE R51 关于就噪声排放方面批准四轮及四轮以上机动车的统一规定53 ECE R52 关于就一般结构方面批准小型公共运输车辆（M2、M3）的统一规定54 ECE R53 关于就灯光及光信号装置的安装方面批准L3类车辆（摩托车）的统一规定55 ECE R54 关于批准商用车辆及其挂车气压轮胎的统一规定56 ECE R55 关于批准汽车列车机械联结件的统一规定57 ECE R56 关于批准轻便摩托车以及类似车辆前照灯的统一规定58 ECE R57 关于批准摩托车以及类似车辆前照灯的统一规定59 ECE R58 关于1.批准后下部防护装置； 2.就已批准的后下部防护装置的安装方面批准车辆；3.就后下部防护装置方面批准车辆的统一规定60 ECE R59 关于批准备用消声系统的统一规定61 ECE R60 关于就驾驶员操纵的控制件，包括控制件、信号装置和指示器的识别方面批准两轮摩托车的统一规定62 ECE R61 关于就驾驶室后挡板之前的外部凸出物方面批准商用车的统一规定63 ECE R62 关于就防盗方面批准带有操纵把的机动车的统一规定64 ECE R63 关于就噪声方面批准两轮轻便摩托车的统一规定65 ECE R64 关于批准装有应急备用车轮/轮胎的车辆的统一规定66 ECE R65 关于批准机动车特别警告灯的统一规定67 ECE R66 关于就上部结构强度方面批准大型客车的统一规定68 ECE R67 关于：1批准在其驱动系统中使用液化石油气的机动车辆特殊装置；2 在这一装置的安装方面批准装用使其驱动系统使用液化石油气的特殊装置的车辆的统一规定69 ECE R68 关于就最大车速的测量方面批准包括纯电动车辆在内的机动车的统一规定70 ECE R69 关于批准低速车辆及其挂车后标志牌的统一规定71 ECE R70 关于批准重，长型车辆后标志牌的统一规定72 ECE R71 关于就驾驶员视野方面批准农用拖拉机的统一规定73 ECE R72 关于批准发射非对称近光和远光并装有卤素灯（HS1灯）的摩托车前大灯统一规定74 ECE R73 关于就侧防护方面批准货车、挂车和半挂车的统一规定75 ECE R74 关于就灯光和光信号装置方面批准L1类车辆的统一规定76 ECE R75 关于批准摩托车和轻便摩托车气压轮胎的统一规定77 ECE R76 关于批准发射远光和近光的轻便摩托车前照灯的统一规定78 ECE R77 关于批准机动车驻车灯的统一规定79 ECE R78 关于就制动方面批准L类车辆的统一规定80 ECE R79 关于就转向装置方面批准车辆的统一规定81 ECE R80 关于就座椅及其固定点方面批准大型客车座椅和车辆的统一规定82 ECE R81 关于就车把上后视镜的安装方面批准后视镜及带与不带边斗的二轮机动车的统一规定83 ECE R82 关于批准装有卤素灯丝灯泡（HS2）的轻便摩托车前照灯的统一规定84 ECE R83 关于根据发动机燃油要求就污染物排放方面批准车辆的统一规定85 ECE R84 关于就油耗测量方面批准装有内燃机的机动车的统一规定86 ECE R85 关于就净功率和最大30分钟电传动系功率的测量方面批准用于驱动M和N类机动车辆的内燃机或电传动系的统一规定87 ECE R86 关于就灯光和光信号装置的安装方面批准农林拖拉机的统一规定88 ECE R87 换向批准机动车白天行车灯的统一规定89 ECE R88 关于批准摩托车反光轮胎的统一规定90 ECE R89 关于1.就最高车速限制或其可调车速限制功能方面批准车辆；2.就已批准型式的最高车速限制装置或可调车速限制装置的安装方面批准车辆；3.批准车速限制装置或可调车速限制装置的统一规定91 ECE R90 关于批准机动车辆及其挂车用可更替制动衬片总成和鼓式制动器衬片的统一规定92 ECE R91 关于批准机动车及其挂车侧标志灯的统一规定93 ECE R92 关于批准摩托车、轻便摩托车和三轮车辆非原装可更换排气消声系统的统一规定94 ECE R93 关于1.批准前下部防护装置； 2.就已批准型式的前下部防护装置的安装方面批准车辆；3.就前下部防护方面批准车辆的统一规定95 ECE R94 关于就前碰撞中乘员防护方面批准车辆的统一规定96 ECE R95 关于就侧碰撞中乘员防护方面批准车辆的统一规定97 ECE R96 关于就发动机污染物排放方面批准农林拖拉机和非道路机动机械装用的压燃式发动机的统一规定98 ECE R97 关于批准车辆报警系统和就报警系统方面批准机动车辆的统一规定99 ECE R98 关于批准装用气体放电光源的机动车前照灯的统一规定100 ECE R99 关于批准用于已获得型式批准的机动车气体放电灯具的气体放电光源的统一规定101 ECE R100 关于就结构、功能安全性和氢排放的特殊要求方面批准蓄电池电动车辆的统一规定102 ECE R101 关于就CO2排放和油耗的测量方面批准装用内燃机的乘用车和就电能消耗量和范围的测量方面批准装用电传动系的M1和N1类车辆的统一规定103 ECE R102 关于1.批准紧耦合装置；2.就已批准的紧耦合装置的安装方面批准车辆的统一规定。
CE认证清单
CE认证所需资料清单1. CE Application（CE申请书）2. General Description of products (产品基本描述)3. Declaration of conformity(符合性宣告书)4. Quality control system & ISO9001certificate（品控系统及其证书）5. Material Certificates (材质证明)6. Material Traceability Procedure (材质追溯程序)7. List of applicable harmonized standard (使用标准与Code清单)8. Hazardous analysis(危害分析)9. ESR checklist(指令要求之重要安全检查表)10. PED Harmonized standard checklist and test report(协调标准符合性检查与测试报告)11. Design Calculation Specification（设计原理与计算说明书）12. Structure Design Diagram（结构设计图纸，包括总装图及其零部件图纸）13. Manufacturing procedures (制造程序)14. Testing procedures(测试程序)15. Inspection records and reports(检查记录与报告)16. NDT Procedure & Personal Approval (Approval by Third Party) (非破坏程序与检测人员资质认可-由3rd party认可)17. National Inspection and type test report(国家检测报告)18. Type-examination report（型式测试报告）19. Operation Instruction (压力容器操作说明书)20. Name Plate and CE marking (CE使用说明书)21. 其它所需资料（针对不同的产品由认证机构提出）。
ce技术主文档
ce技术主文档Technical File一次性使用无菌安全自毁型注射器带针Disposal sterile safety & auto-disable syringe,with needle一次性使用无菌注射器带针Disposal sterile syringe,with needleDrafted by：Approved by：Number：Revision：AStatus：ControlledDate：有限公司Co.,Ltd.地址：Address:电话：传真：E-mail：目录第一章：产品简介1.1 生产商信息单位名称：英文：地址：Address:电话：传真：E-mail：联系人：1.2 公司简介有限公司是一家医疗机械专业生产企业。
公司位于村镇，占地面积近两万平米，以生产注射器、输液器等一次性医用耗材为主。
公司环境优美，拥有雄厚的技术力量和先进的生产设备以及精确的检测仪器。
公司将秉承“专业、务实、创新、奉献”的精神，为国内外用户提供产品和服务。
简介写的有点简单，可以增加点：公司的注册资金、人员情况、部门设置、设备情况、生产的产品情况、销售区域等等）1.3、公司组织机构图：Company Organization Structure1.4 关键原材料、供方及认证证书：（证书见附件1 ）1.4.2产品关键件清单注：注射针外购，检验报告见附件1.5 产品描述一次性使用无菌安全自毁型注射器带针Disposal sterile safety & auto-disable syringe,with needle 一次性使用无菌注射器带针Disposal sterile syringe,with needle1.5.1产品主要结构：a)一次性使用无菌安全自毁型注射器带针产品结构：由芯杆、连接座、外套、胶塞、注射针组成。
01—芯杆；02—外套；03—橡胶活塞；04—连接座；05－密封圈；06—注射针；07—注射针护套b)一次性使用无菌注射器带针产品结构：由芯杆、外套、胶塞、注射针组成。
工业机械ce认证需准备的技术文件...
工业机械ce认证需准备的技术文件（Technical documents to be prepared for CE certification of industrial machines）Technical documents for industrial machinery CE certification preparation1.1 design documentsProduct design is the key link to decide the quality of the products, the product can meet the basic requirements of the new directive method, the key lies in the product design is complying and satisfy these requirements, and this information is through a series of technical documents to be expressed. These technical documents generally include:(1) the provisions of the basic requirements, product design should comply with the standards and other technical specifications, or to meet the basic requirements of the design of the input file to take measures. Such as product design or technical task, product standard requirements; (2) the design drawings to reflect the products to meet the basic requirements and implement the relevant technical measures and contribute to the product installation, use and maintenance etc.. Such as structure, product installation diagram, electrical system diagram, hydraulic system diagram and other relevant departments of the drawings and other power sources; (3) as a technical document or verify the design basis, design calculations, such as checking books, technical analysis documents; (4) with technical documents to guide the user to correct installation and maintenance for the correct operation, and express or warning of danger or possible danger, such asproduct installation instructions, product operation and maintenance instructions, safety manuals etc..The 1.2 risk analysis and measures of documentsUnder the new approach directives is the basic requirements of the protection of the public interest, harm, and the basic requirements for specific products may potentially result, manufacturers must be able to identify the product through the analysis, the potential hazard of all these dangerous and serious degree, in order to determine the basic requirements must be met and the measures should be adopted to eliminate all possible accident risk. At the same time, manufacturers should take these measures for analysis and evaluation and documentation, to prove that the products can meet the relevant basic requirements of the new directive method. These documents include the analysis and evaluation of potential risk existing in the products may file, and to eliminate the risk of the measures taken by the documents and to prove the effectiveness of these measures to confirm the documents.1.3 production documentsFor the continuous or batch production of the product, in order to ensure the consistency of the product and the subsequent production of products through the CE certification mark, the manufacturer should take the necessary technical and management measures in the production of manufacturing products, ensure the production process will not cause adverse effects on the products to meet the basic requirements of the new order, and these measures of documentation, in order to beable to continue to carry out. At the same time, through these documented proof measures manufacturer has the ability to ensure that the products always accord with the design requirements (consistent with the prototype). These documents include technical measures, manufacturers take the quality management measures, documents, special measures such as the processing of the key parts adopt foreign purchase of raw materials and parts of the quality control measures of documents, management and control of the production process of product inspection, file management control files.1.4 compliance verification and certification documentsCompliance verification and certification documents mainly refers to those related to the basic requirements of direct or indirect proof of products or components to meet the new methods of instruction required documents.(1) a new method of instruction products used in covering products (including equipment, instruments, equipment, tools, materials, components, parts, components, or safety connectors, accessories or system), should be in addition to CE marks on the outside, should also obtain these products meet the basic requirements of the new proof method of instruction the product, such as EC, declaration of conformity EC type examination certificate or a copy of the necessary technical documents and other documents;(2) the main parts may affect the safety or environmental performance in the product (does not belong to the new methods of instruction coverage), to obtain the inspection or testreport issued by authorities, copy or safety certificate of the components have been obtained and other relevant certificates;(3) for spare parts, accessories or whole machine manufacturers need to study or test to determine whether the machine safety in the design or manufacturing of installation and delivery of documents, such as test reports, research reports;(4) even without the requirement of manufacturing instructions that need, can also provide technical report or certificate of the product obtained from the authority with legal qualifications and laboratory;(5) a new method for the instruction of third party (announcement of EU institutions designated) participate in the qualification assessment, should notice issued by the agency of EC type and EC type inspection report inspection certificate;(6) manufacturers draft, signed EC declaration of conformity.1.5 other documentsIn addition to the four aspects listed above the documents, the general should also develop and maintain the following documents:(1) the basic situation of enterprises information documents;(2) the basic requirements, a new method of instruction contains the product conforms to the standards adopted by the technical specifications and other documents; (3) the basicrequirements, the new directive method of products should meet the coordination standard and the other standards and technology specifications and other documents; (4) if the manufacturer appointed his authorized agent in EC, should establish a clear definition to the task and the authorization written authorization; (5) if the product is applicable to conformity assessment mode for ENISO9001, 9002 or 9003 standards based, the manufacturer provided for new methods to meet the instruction the requirements in the implementation and application of the quality system, should be put on the product symbol, quality planning, quality manual and document control, And coordinate standard or technical measures to ensure that the products meet the basic requirements of the file.。
CE技术文档清单最新-CE(中英文)
Packaging and specification
(English version)
13.3
Description of the manufacturing processes
Drawings, qualification,Labeling control,Traceability,Product and environmental bioburdenparticles,Pyrogene testing,Preventive monitoring of processes (i.e. SPC),Viral- Prion Desactivation stepsetc.
3
Product description
3.1
Product name,classification of the device and accessories
3.2
List of accessories (if applicable)
3.3
Specification, model and article numbers
2007有固定模板需提交英文文件临床报告详细的临床数据见part标签包括产品标签包装标签需提交英文文件10使用说明患者信息广告材料需提交英文文件11符合性声明有固定模板需提交英文文件12与产品有关的质量体系的信息13详细的产品描述131设计图及产品技术规范132包装条件及规格需提交英文文件133生产过程描述包括流程图资格确认标签控制追溯性产品及生产环境控制过程的预防监控消毒或防护过程等134原材料和供方14试验验证及评估报告141灭菌方法和验证的概述灭菌证书适用时iqoqpq142包装验证适用时包括包装有效期验证143化学物理和生物学试验验证或评估报告15临床数据临床评价报告必须包含在技术文档的第一部分中报告中引用的出版物必须以原始文件重印本或复印件的形151临床前评估专家意见152临床方案153临床数据成在技术文档的第二部分提供154临床总结专家意见155临床报告156相关文献
CE认证中英文介绍
1 前言Introduction欧洲议会和欧洲理事会于2006年5月17日正式通过了，产品申请CE认证(CE-Marking即CE标志)的最新版机械指导法令(2006/42/EC)，此法令是欧盟按照新方法(New approach)制定的有关健康、安全的基本法令之一。
与现行机械指令98/37/EC相比，新指令在适用范围、与其他指导法令的界线、市场临督、安全性零组件、合格评定程序以及基本健康和安全要求等方而都出现了一些新要求和明显的变化。
European Parliament and European Council have adopted the latest version of the Machinery Directive (2006/42/CE) on 17 May, 2006. This new directive is made according to a new approach; its one of the basic directives on health and safety concern. Compared with the present Machinery Directive 98/37/EC there are some new requirements and noticeable changes to the new one on its application, boundary with other directives, market supervision, safe components, conformity assessment procedure, the requirement for the basic health and safety, etc.面对新的技术壁垒，相关部门和广大企业应提前做好研究，有关欧盟对CE认证(CE-Marking)的新规定,及早从实际应用和技术角度出发加以积极应对。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
Preclinical Evaluation, Expert Opinions
15.2
Clinical plan
15.3
Clinical datas
15.4
Clinical Summary, Expert Opinions
15.5Βιβλιοθήκη Clinical report15.6
Relevant Literature
技术文档的内容
内容
备注
Part A
1
制造商和欧洲代表的名字、地址
2
质量体系所涉及的全部制造场所清单
3
产品描述
3.1
产品名字、器械及附件的分类
3.2
产品附件清单（适用时）
3.3
规格、型号及货号
3.4
符合性评价路径
3.5
预期用途描述
3.6
主要的销售单元（适用时）
3.7
简要的产品历史（包括现有的管理审批）
(template, English version)
Part B
12
Information concerning the quality system specific to the product
13
Detailed descriptions of the product
13.1
Design drawings and product specifications
4
适用的标准清单
符合医疗器械指令附录I
5
基本要求检查表
符合医疗器械指令附录I的方案
(有固定模板，需提交英文文件)
6
产品的总体生产或质量控制方案
7
风险分析
EN ISO 14971:2007
有固定模板，需提交英文文件
8
临床报告
详细的临床数据见Part B
9
标签，包括产品标签、包装标签
(需提交英文文件)
10
CE技术文档须知
Contents of Technical File
Contents
Notes
Part A
1
Name, Postal Address of Manufacturer /EU Representive
2
A listing of all manufacturing sites covered by the quality system
9
Labelling, inl.Product labels and package labels
(English version)
10
Instruction for use, patient information,advertising material
(English version)
11
Declaration of conformity
4
List of harmonized standards
Satisfy the Annex I
5
Essential Requirements checklist
the solutions adopted to satisfy the Essential Requirements
(template, English version)
3
Product description
3.1
Product name,classification of the device and accessories
3.2
List of accessories (if applicable)
3.3
Specification, model andarticlenumbers
3.4
Chosen conformity assessment path
3.5
Intended use
3.6
Integral parts of the sales unit
3.7
Abrief product history (including existing regulatory approvals)
6
Overall manufacturing and inspection plan of the product
7
Risk analysis
EN ISO 14971:2007
(template, English version)
8
Clinical report
Detailed see in Part B
15.1
临床前评估，专家意见
15.2
临床方案
15.3
临床数据
15.4
临床总结，专家意见
15.5
临床报告
15.6
相关文献
13.2
Packaging and specification
(English version)
13.3
Description of the manufacturing processes
Drawings, qualification,Labeling control,Traceability,Product and environmental bioburdenparticles,Pyrogene testing,Preventive monitoring of processes (i.e. SPC),Viral- Prion Desactivation stepsetc.
Incl. package expired date
14.3
Chemical, physical and biology test, verification and evaluation report
15
Clinical datas
The critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies.
13.4
Raw materials and suppliers
14
Test, verification and evaluation report
14.1
Sterile method and validation
IQ/OQ/PQ
14.2
Packaging verification (if applicable)
13.4
原材料和供方
14
试验、验证及评估报告
14.1
灭菌方法和验证的概述，灭菌证书（适用时）
IQ/OQ/PQ
14.2
包装验证（适用时）
包括包装有效期验证
14.3
化学、物理和生物学试验、验证或评估报告
15
临床数据
临床评价报告必须包含在技术文档的第一部分中，报告中引用的出版物必须以原始文件、重印本或复印件的形成在技术文档的第二部分提供
使用说明、患者信息、广告材料
(需提交英文文件)
11
符合性声明
(有固定模板，需提交英文文件)
Part B
12
与产品有关的质量体系的信息
13
详细的产品描述
13.1
设计图及产品技术规范
13.2
包装条件及规格
(需提交英文文件)
13.3
生产过程描述
包括流程图、资格确认、标签控制、追溯性、产品及生产环境控制、过程的预防监控、消毒或防护过程等