医疗器械生产指令单-模板
98-79-EC体外诊断医疗器械指令(中文版)
内部资料强制实行法规欧洲议会和欧盟理事会体外诊断医疗器械指令 98/79/EC1998年10月27日强制实行法规欧洲议会和欧盟理事会体外诊断医疗器械指令98/79/EC第1条范围·定义………………………………………………………………………第2条上市和投入使用………………………………………………………………………第3条基本要求………………………………………………………………………第4条自由流通………………………………………………………………………第5条标准………………………………………………………………………第6条标准和技术法规委员会……………………………………………………………第7条医疗器械委员会………………………………………………………………………第8条安全保障条款………………………………………………………………………第9条合格认证程序………………………………………………………………………第10条制造者和器械的注册登记……………………………………………………………第11条防范程序………………………………………………………………………第12条欧洲资料库………………………………………………………………………第13条特别卫生监督措施………………………………………………………………………第14条对附录II的修订和降低条款……………………………………………………………第15条指定认证部门………………………………………………………………………第16条C E标志………………………………………………………………………第17条C E标志使用不当………………………………………………………………………第18条拒绝或限制的规定………………………………………………………………………第19条保密规定………………………………………………………………………第20条成员国之间的合作………………………………………………………………………第21条指令的修订………………………………………………………………………第22条执行，过渡规定………………………………………………………………………第23条生效日期………………………………………………………………………第24条发给成员国………………………………………………………………………附录I 基本要求…………………………………………………………………………………附录II 和第9（2）及9（3）条有关的器械清单…………………………………………………附录II I E C合格声明……………………………………………………………………………附录IV E C 合格声明（全面质量保证体系）……………………………………………………附录V E C样品检查…………………………………………………………………………附录V I E C验证…………………………………………………………………………………附录VI I合格声明（生产质量保证）……………………………………………………………附录V I I I性能评价器械的报告书和程序………………………………………………………附录I X指定认证部门的选派准则……………………………………………………………附录X C E合格标志……………………………………………………………………………强制实行法规欧洲议会和欧盟理事会体外诊断医疗器械指令98/79/EC1998年10月27日欧洲议会和欧盟理事会根据欧共体成立条约第100a条的规定和欧盟委员会的建议，征求了经济和社会委员会的意见，按照条约第189b条所规定的程序，并鉴于下列各点，发布此指令。
MDD 93-42-EEC医疗器械指令 全部(中文)
欧洲共同体理事会关于医疗器械的93/42/EEC指令1993年6月14日欧洲共同体理事会考虑到建立欧洲经济共同体的条约，特别是其第100a条；考虑到欧洲共同体委员会提交的议案；考虑到与欧洲议会合作；考虑到经济与社会委员会的意见；鉴于应在欧洲共同体内部市场范围内正式通过必要的措施；鉴于欧洲共同体内部市场是一个确保商品、人员、服务和资本自由流通的无内部边界的区域；鉴于各成员国有关医疗器械的安全、健康保护和工作特性的法律、法规和行政条款的内容和范围是不同的；鉴于各成员国之间对这类器械的认证和检验程序存在差异；鉴于这种差异在欧洲共同体内形成贸易壁垒；鉴于各国针对医疗器械的使用所制定的有关患者、使用者及其他人员的安全和健康保护的条款应予以协调，以保证此类器械在欧洲共同体内部市场自由流通；鉴于协调条款必须与成员国为管理直接或间接与这类器械有关的公共健康和医疗保险计划的资金筹措而采取的措施相区别；鉴于因而只要遵守欧洲共同体法律，这些条款并不影响各成员国实施上述措施的能力；鉴于医疗器械应向患者、使用者及第三方提供高水平的保护并达到制造商赋予其的性能水平；鉴于因此保持和提高各成员国已达到的保护水平是本指令的基本目的之一；鉴于在1965年1月26日欧洲共同体理事会关于使有关特许专卖药品的法律、法规或行政措施趋于一致的65/65/EEC指令中，某些医疗器械是用于施药的；鉴于在这种情况下，医疗器械投放市场通常由本指令管理，而药品投放市场由65/65/EEC指令管理；鉴于如果这种器械投放市场的方式使器械与药品构成一种规定只供组合使用且不能再次使用的整体，则这个单一整体产品应由65/65/EEC指令管理；鉴于必须将上述器械与包含某种物质，特别是当其单独使用时，按65/65/EEC指令可视为药物的医疗器械相区别；鉴于在这种情况下，若这种物质能配合医疗器械对人体产生辅助作用，则这类器械投放市场由本指令管理；鉴于这类物质的安全性、质量和有效性必须比照欧洲共同体理事会1975年5月20日关于使成员国有关分析标准、药物毒理学标准和临床标准及特许专卖药品试验协议的法律趋于一致的75/318/EEC指令规定的适当方法加以验证；鉴于本指令附录中的基本要求和其他要求，包括对“减小”或“降低”危险的任何引用，在解释和实施时必须考虑设计时的技术现状和实际做法及高水平的健康和安全相适应的技术与经济条件；鉴于按照1985年5月7日欧洲共同体理事会关于技术协调与标准化新方法的决议所规定的原则，有关医疗器械设计和生产的规定必须限于满足基本要求所必须的条款；鉴于因为这些要求是基本的，因此它们应取代各国相应的条款；鉴于实施基本要求应审慎考虑设计时的技术水平和与高水平的健康及安全保护相适应的技术、经济条件；鉴于1990年6月20日欧洲共同体理事会关于使成员国有关有源植入式医疗器械的法律趋于一致的90/385/EEC指令是新方法指令在医疗器械领域中的首次应用案例；鉴于为了使欧洲共同体的统一规定适用于所有医疗器械，本指令基本上是以90/385/EEC指令的条款为依据的；鉴于为此必须修订90/385/EEC 指令，以便放入本指令规定的一般性条款；鉴于电磁兼容性问题是医疗器械安全的一个组成部分；鉴于就1989年5月3日欧洲共同体理事会关于使成员国有关电磁兼容的法律趋于一致的89/336/EEC指令而言，应包含这方面的专门规定；鉴于本指令应包括有关发射电离辐射的器械在设计和制造方面的要求；鉴于本指令既不影响1980年7月15日欧洲共同体理事会80/836/Euratom指令对有关保护公众和工人免受电离辐射危险的基本安全标准的指令进行修订所要求的授权，也不影响欧洲共同体理事会1984年9月3日对接受医疗检查和治疗的人员的辐射防护规定了基本措施的84/466/Euratom指令的实施；鉴于欧洲共同体理事会1989年6月12日关于采取措施鼓励改善工人工作中的安全和健康的89/391/EEC指令以及有关这一问题的专门指令应继续予以实施；鉴于为了证实符合基本要求并使这种符合得到验证，需要制定欧洲协调标准来防止与医疗器械的设计、制造和包装有关的危险；鉴于这类欧洲协调标准是由非官方机构制定的，应保持其非强制性的地位；鉴于为此欧洲标准化委员会（CEN）和欧洲电工标准化委员会（CENELEC）按照1984年11月13日欧洲共同体委员会与这两个机构之间签署的合作总指导原则，被认可为批准协调标准的主管机构；鉴于在本指令中，协调标准是受欧洲共同体委员会委托，由上述两机构之一，或两个机构共同根据欧洲共同体理事会1983年3月18日关于在技术标准和法规领域提供信息程序的83/189/EEC指令，依照上述总指导原则而批准的技术规范（欧洲标准或协调文件）；鉴于对协调标准进行修订，欧洲共同体委员会应得到根据83/189/EEC指令建立的常设委员会的帮助；鉴于应采取的措施必须按欧洲共同体理事会87/373/EEC决定中规定的程序Ⅰ而规定；鉴于在特定领域，欧洲药典专著这类现有的形式应包括在本指令的范围内；鉴于因此有几部欧洲药典专著可视为等同于上述协调标准。
医疗器械指令介绍
医疗器械指令(MDD)医疗器械指令(MDD)欧盟为消除各成员国间的贸易壁垒，逐步建立成为一个统一的大市场，以确保人员、服务、资金和产品（如医疗器械）的自由流通。
在医疗器械领域，欧盟委员会制定了三个欧盟指令，以替代原来各成员的认可体系，使有关这类产品投放市场的规定协调一致。
这三个指令分别是：1．有源植入性医疗器械指令（AIMD，90／335／EEC），适用于心脏起搏器，可植入的胰岛素泵等有源植入性医疗器械。
AIMD于1993年1月1日生效。
过渡截止期为1994年12月31日，从1995年1月1日强制实施。
2.活体外诊断器械指令（IVD），适用于血细胞计数器，妊娠检测装置等活体外诊断用医疗器械。
该指令目前仍在起草阶段，可能于1998年末或1999年初正式实施。
3．医疗器械指令（Medical Devices Directive，93／42／EEC），适用范围很广，包括除有源植入性和体外诊断器械之外的几乎所有的医疗器械，如无源性医疗器械（敷料、一次性使用产品、接触镜、血袋、导管等）；以及有源性医疗器械，如核磁共振仪、超声诊断和治疗仪、输液泵等。
该指令已于1995年1月1日生效，过渡截止日期为1998年6月13日从1998年6月14日起强制执行。
上述指令规定，在指令正式实施后，只有带有CE标志的医疗器械产品才能在欧盟市场上销售。
我国医疗器械生产企业及出口公司在将其产品销往欧盟市场时，必须符合上述指令规定，加贴CE标志，否则产品难以进入欧盟市场。
由于我国在这方面宣传力度不够，虽然上述三个指令中的AIMD已强制实施多年，MDD也于去年6月14日强制实施，但目前还有众多的医疗器械生产厂家及出口公司对这些要求不甚了解，因此今年我国的医疗器械出口将面临严峻的考验。
本文先介绍这三个指令中适用范围最广的MDD，并对目前申请CE标志时应注意的一些问题作较详细的解释，供有关方面参考。
a.医疗器械指令，MDDMDD是目前欧洲可见到的最为全面的医疗器械方面的规定，在该指令中，共有23个条款和12个附录。
医疗器械 批生产记录
医疗器械批生产记录记录编号：XX公司-001批生产记录品名：一次性医用口罩规格：17.5cm*9.5cm产品批号：1包装规格：按国家标准及行业标准要求生产周期：XX天目录：1.批生产指令单2.领料单3.称量、备料工序生产记录4.原材料交接单5.制作工序生产记录6.中间产品检验记录7.返工记录表8.中间产品交接单9.包装工序批包装记录10.不合格品处理单11.退料单12.清场工作记录13.清场合格证14.生产过程工艺质量监控记录15.入库单16.成品请验单17.成品检验原始记录18.成品检验报告书19.成品放行审核单20.销毁记录批生产指令单：产品名称：一次性医用口罩批号：1指令下达人：XXX审核人：XXX产品质量重点说明：关键原材料清单：一次性医用口罩产品内外层面料采用纺粘无纺布材料，中间过滤层采用聚丙烯熔喷无纺布材料，鼻夹采用金属裹塑材料，耳带采用弹性材料，包装袋等上述材料均应符合国家标准及行业标准，并严格按照材料限定的使用范围使用。
关键工艺控制点：1.开机调试：确保设备运行正常、设备参数设置稳定，符合生产工艺要求。
2.压合成型：确保压合出的半成品符合工艺要求，其中结构与尺寸应符合设计的尺寸，耳挂式口罩基本尺寸如下：长（cm）：17.5宽（cm）：9.5允差（%）：±5鼻夹长度：应不小于8.0cm。
3.耳带焊接：每根口罩带与口罩体连接点处的断裂强度应不小于10N。
4.内包装封口：包装封口应密封完好、整齐符合工艺要求。
备注：一次性使用医用口罩规格：17.5cm*9.5cm批量：1下达日期：XX年XX月XX日领料单：操作类型：领料日期：年月日仓管员：XXX领料人：XXX产品名称：一次性使用医用口罩批号：1规格物料批号：17.5cm*9.5cm操作指令序号：010203物料名称：领用量：备注：称量、备料工序生产记录：称量人：XXX复核人：XXX产品名称：一次性使用医用口罩批号：1规格批号：17.5cm*9.5cm操作指令序号：物料名称：领用量：物料状态：备注：原材料交接单：产品名称：一次性使用医用口罩规格：17.5cm*9.5cm批号：1物料：原材料原材料状态：进入下一工序：口罩制作交料工序：备料以上是一次性医用口罩的生产记录，严格按照国家标准及行业标准要求进行生产，确保产品质量。
医疗器械生产记录表格
受控文件清单（1.质量文件）编号：JL –4.2.3-01记录：受控文件清单（2.管理文件）编号：JL –4.2.3-01记录：受控文件清单（3.技术文件）编号：JL –4.2.3-01记录：受控文件清单（4.外来文件）编号：JL –4.2.3-01记录：1.1数学八年级上册同步练习：12.2.1三角形全等的判定SSS 3文件发放回收记录表编号:JL-4.2.3-026v文件借阅、复制记录表编号：JL –4.2.3-03文件更改申请单编号：JL –4.2.3-04文件销毁申请单编号：JL –4.2.3-05文件留用申请编号：JL –4.2.3-06文件更改、销毁、留用记录表编号：JL –4.2.3-07记录人：文件归档清单编号：JL –4.2.3-08记录人：部门质量记录清单编号：JL –4.2.4-01公司质量记录清单编号：JL –4.2.4-02法律法规文件阅读记录请参阅人员快速传阅，尽快返回办公室。
法律法规文件阅读记录请参阅人员快速传阅，尽快返回办公室。
年度培训计划编号：JL –6.2-02员工培训考核记录表编号：JL –6.2-01培训申请表编号：JL –6.2-02培训合格率汇总表编号：JL –6.2-03记录人：培训记录编号：JL –6.2-04记录人：员工培训档案编号：JL –6.2-05设备购置申请表编号：JL –6.3-01设备验收单编号：JL –6.3-02设备保养（检修）计划编号：JL –6.3-03编制：日期：批准：日期：1.1数学八年级上册同步练习：12.2.1三角形全等的判定SSS 3月设备保养记录表注:保养项目:1、日保养为对检测仪品进行性能自检和清洁，“○”表示日保养已执行；2、周保养为设备清洁和性能自检、保养，“√”表示周保养已执行；3、30v月保养为计算机性能自检、杀毒、清洁，“△”表示月保养已执行。
“×”表示有异常情况，应在“异常情况记录”栏予以记录。
93-42-EC 医疗器械指令
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关于医疗器材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;鉴于内部市场之完成应采取一些措施; 鉴于内部市场是一无内部疆界之区域, 区域内之货品, 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材之安全, 对健康之保护及使用特性方面之法律, 法规及行政命令之内容与范围不尽相同; 鉴于各会员国对此器材之验证及检验程序也不相同; 鉴于前述之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;鉴于医疗器械之使用对病患, 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, 以保证此类器材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;鉴于调和之规定必然与各会员国采取之部分措施有所不同, 这些措施是为筹措公共健康与疾病保险计划之基金, 且直接或间接与医疗器材有关; 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;鉴于医疗器材应提供病患, 使用者及第三者高度之保护, 且应该达到厂商所要求之性能水准; 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之一;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;鉴于部分医疗器材是符合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之法律, 法规或管理行为所订之实施规定, 鉴于医疗器材之上市基本上由本指令规范, 但医疗产品之上市则受65/65/EEC号指令规范; 鉴于若有某种器材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; 鉴于前述之医疗器材和包含医疗物质且该物质单独使用时符合65/65/EEC号指令规定之医疗器材应加以区别; 鉴于前述包含于医疗器材之医疗物质若对人体产生作用以辅助医疗器材之作用时, 则该医疗器材之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之标准及调查书的法律调和], 医疗物质之安全, 品质及效用在前述情况下则须依该指令明定之适当方法加以证实;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;鉴于本指令附件所订之基本要求及其他要求, 包括[最低]或[降低]危险部分之应用, 应考虑设计当时之科技及实施情形, 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, 有关医疗器材之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, 所以应取代对应之国家规定;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;鉴于基本要求之落实应谨慎考虑设计当时之科技水准, 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 Directiveis 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材法律调和] 之理事会指令是第一个应用在医疗器材方面的新方法指令; 鉴于为使共同体规定适用于所有的医疗器材, 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之一般条款的部分;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;鉴于医疗器材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]之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材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之其他指令; 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之基本方法] 理事会指令之适用; 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之安全与健康]及其他相关主题之指令应持续适用;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, 有必要建立调和之欧洲标准, 以避免医疗器材在设计, 制造及包装上所可能带来的危险, 鉴于调和之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日通过之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之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之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材之应用, 可以依相关器材之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; 鉴于医疗器材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材分为四类; 鉴于分类是以考虑器材之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类医疗器材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)类医疗器材而言, 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类之医疗器材对人体具有较高的潜在危险, 因此在器材的设计及制造阶段必须有公告机构的检验; 鉴于第III类的器材皆为较特别的器材, 其一致性需在上市之前获得明确授权;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;鉴于器材之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材在市场上销售之人员, 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;鉴于医疗器材应附加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病毒感染的医疗器材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 amongstthe 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材分类; 鉴于医疗器材性质及相关领域技术进步之性质各异, 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材的分类或再分类, 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材符合安全要求; 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] 之指令中所提及的医疗器材亦受本指令规范; 前述指令因此必须撤销;基于同样原因, 理事会1984年9月17日通过之84/539/EEC号指令[有关各会员国人类或动物医疗使用之电动医疗器材法律调和],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材及其附属物. 附属物在本指令的适用范围内亦视其为医疗器材. 两者以下皆称器材.2. For the purposes of this Directive, the following definitions shall apply:为本指令之目地, 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:[医疗器材]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之仪器, 设备, 器材, 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之目地而订定:- 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,解剖或生理过程中之检查, 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;这些器材不可借药性, 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, 但可用这些器材辅助其功能者;(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材, 制造商设计附属件之目地是配合其他器材合并使用, 使该器材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;[体外诊断用器材] 是指任何自成单位或与其他物件组合之任何试剂, 试剂品, 套装用具, 仪器, 设备或系统形态的器材. 这种器材是制造商设计作为检查人体组织标本用的器材, 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.[订制的器材] 是指依照合格医疗从业人员描述的特色而特别制作的器材, 该器材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;但订制的器材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材 .(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.[临床调查用之器材]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, 执行附件十第2.1.所述之调查时所使用的任何器材.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]是指器材以其名称上市前, 负责器材之设计, 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材, 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之器材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]是指器材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之目的, 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之器材的行为;(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]是指某一器材在共同体市场首次可依原订之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号指令第一条定义之医疗产品的器材, 在不侵害65/65/EEC号有关医疗产品指令条款的规定下, 该类器材应受本指令规范.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 notreusable, 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, 假若某种器材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. 本指令附件一所列有关器材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.如果医疗器材包含某项医疗物质, 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材的作用时, 该器材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材:(a) in vitro diagnostic devices;体外诊断器材;(b) active implantable devices covered by Directive 90/385/EEC;受90/385/EEC号指令规范之主动植入式医疗器材;(c) medicinal products covered by Directive 65/65/EEC;受65/65/EEC号指令规范之医疗产品(d) cosmetic products covered by Directive 76/768/EEC;受76/768/EEC号指令规范之化妆品;(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;人类之血液, 血液产品, 血浆或血球, 或者上市时包含人类血液产品, 血浆或血球的器材;(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells ofhuman origin;人类之移植器官, 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.动物之移植器官, 组织或细胞; 但利用死的动物组织或其产品而制造的器材则不在此限.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, 以确保器材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.器材依其设计的目的必须符合附件一所列适用的基本要求, 并顾及器材原先预期的用途.Article 4第 4 条Free movement, devices intended for special purposes自由流通及特殊目的的器材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标示器材之上市及使用设立任何障碍, CE 标示代表该器材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:对于下列器材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,符合第十五条及附件八规定, 供医疗从业人员或经授权之人员执行临床调查而制造的器材- 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.符合第十一条及附件八规定上市及使用的订制器材; 属于第IIa, IIb, 及III类器材须附有附件八所提之说明资料.These devices shall not bear the CE marking.上述器材无需附加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.对于未符合本指令之器材, 但有明显的标识说明该器材在未符合本指令之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, whena 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之医疗器材, 其依附件一第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.若某器材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标示附加之说明, 则其CE标示表示该器材亦符合其他指令的条款.。
批生产计划指令单(生产科)(表格模板、doc格式)
PF-03-01-00
批生产计划指令单
开放的课程观要求我们充分利用各种课程资源，创造性地使用教材。要注意联系本地区和学生的实际，关注社会中新的信息、学生生活中新的问题和现象，对教科书中提出的问题、预设的活动进行合理的拓展和延伸，及时、合理地调整教学目标，灵活有效地推进教学过程，增强教育的针对性品名
你相信“人若有志，就不会在半坡停止。”就学习的阶段性而言，你处在初中的半山腰；就你进步的阶段而言，你也处在半山腰，这座右铭包含了你对自己的鼓励，希望你能真正意义上的做到勇往直前！
你文文静静，秀气美丽，课堂上总是眨巴着乌溜溜的眼睛专心地听讲，作业完成得认真又整洁，每次值日你都能有始有终，认真完成，老师真喜欢你。如果在课堂上积极举手发言，那你的思维会更加敏捷，口头表达能力会更加出色。勇敢些，相信你能行。指令编号
规格Leabharlann 批号计划产量工艺规程或编号
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医疗器械生产记录表格模板.doc
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医疗器械指令MDD基本要求检查表
93/42/EEC including 2007/47/ECAnnex IEssential Requirements Checklist93/42/EEC包括2007/47/EC基本要求检查表Product name:产品名：Type(s)/Model(s):类型/型号Product group:产品族Issue date of Technical File:技术文档发布日：Revision of Technical File:技术文档修订版本：Legal Manufacturer:法定制造商Name 名字：Street 街道：Postal code邮编Place地点Country 国家Accessories:附件：Date 日期Name Reviewer 1/审核人1的名字Signature Reviewer 1/审核人1签字Date日期Name Reviewer 2/审核人2的名字Signature Reviewer 2/审核人2签字更多免费资料下载请进：好好学习社区Checklist according to annex I of the Medical Device Directive(MDD)按医疗器械指令（MDD）附录一的基本要求检查表A/NA适用/不适用Standards, other directivesand other rules applied bymanufacturer制造商引用的标准，其它指令或规则Documentation (test reports,protocols, literature or reasonfor no applicability)支持性文件(测试报告，方案，文献或不适用的理由)Requirementsfulfilled( to be filled in byNotified Body)要求满足(由公告机构填写)Ok /Fail符合 /不符合I. General Requirements通用要求1.The devices must be designed and manufactured in sucha way that, when used under the conditions and for thepurposes intended, they will not compromise the clinicalcondition or the safety of patients, or the safety andhealth of users or, where applicable, other persons,provided that any risks which may be associated withtheir intended use constitute acceptable risks whenweighed against the benefits to the patient and arecompatible with a high level of protection of health andsafety.器械的生产和设计必须保证：按照其预定用途和条件使用，器械不会损害临床条件、或患者安全、或操作者或其他人员的安全和健康；假设与器械预期用途相关的任何风险，与之给患者带来的益处相比，并与健康安全的保护程度相一致，则是可接受的。
医疗器械指令要求控制程序(含记录)
医疗器械指令要求控制程序（ISO13485-2016）1.0目的正确理解和执行《医疗器械指令》（MDD）的要求，确保本公司带有CE标志的产品符合MDD指令要求。
概括为：a）全部产品应满足指令的要求；b）每种产品在投放市场之前应通过《符合性声明编写程序》的要求；c）所有已通过符合性评价的产品应带有CE标志。
2.0适用范围本要求适用于带有CE标志的产品，同时也是对《质量手册》中质量管理体系（总要求）的补充。
3.0职责3.1总经理对公司带有CE标志的产品质量负责。
3.2管理者代表负责组织建立满足MDD指令要求的文件化程序和组织制定技术文件编写规范，并负责分工。
3.3研发部、外贸部、办公室等各职能部门按照分工编制相关文件并付诸实施。
3.4总经理负责确定销售商、欧盟授权代表及其职责；并负责审批上述文件。
4.0控制要求为了使产品获得CE标志，产品应全部符合以下要求。
4.1产品分类正确实施产品分类以合理选择CE符合性认证的途径。
本公司按照07/47/EC指令《附录Ⅸ分类准则》对华汉针神诊疗健身仪进行分类。
分类须考虑产品使用时间、使用部位、创伤性以及有无能量交换等情况，具体按照《产品分类程序》实施。
4.2基本要求a）本公司按照07/47/EEC指令《附录Ⅰ医疗器械的基本要求》中的六项“一般规定”、八项“设计和制造方面的要求”，逐一对不同型号的产品进行适用或不适用的判定，并对适用条款标出采用的标准，注明符合的证据及其查阅地点。
b）只有满足基本要求的产品才是安全有效的，才能进入市场。
为此应采用欧洲标准委员会（CEN）和欧洲电器技术标准委员会（CENELEC）制定的有关协调标准进行设计和生产。
具体见《基本要求检查表》。
本公司产品符合基本要求的证明在于：依据产品分类结果，采用附录Ⅶ+Ⅴ建立质量体系，自我评估、声明其符合性，并接受公告机构的审核。
4.3产品标签、说明及语言为了对使用者提供准确的信息以及确保带有CE标志的产品在欧盟市场通行，应规范产品标签、说明书的内容和语言形式，并正确使用CE标志。
生产指令单-Word格式
佳美源实业有限公司订单生产指令单
客户代号：荣达制单日期：Dec 17,2005
订单编号：126289 出货日期：Jan 23,2005
项次工厂编号客户编号产品内容描述数量包装方式备注001 306463 黑色POLY带灯喷泉
水泵：AP300L 标准出瑞士规格
卵石：3.0KGS 2-3CM直径的卵
石，卵石的颜色请尽量用白灰色
的颜色
300 1PC/PE袋/保
力龙/五层内盒
2PCS/外箱
注意事项：
1．订单产品请按照工厂留底样正确生产，请注意产品的底盒内壁为不光滑面，外壁为光滑面；2．产品生产均请生产色胚，上景的透明中柱请注意透明度
3．产品的包装所须的其它标贴及说明书请待客人通知。
业务：徐丽雯审批：工程：制造：。