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1、ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrd
2、s制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合I.I.GENERAL REQUIREMENTSGENERAL REQUIREMENTS 基本要求基本要求ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用
3、适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合1.1.The devices must be designed andmanufactured in such a way that,when usedunder the conditions and for the purposesintended,they will not compromise theclinical condition or the
4、safety ofpatients,or the safety and health of usersor,where applicable,other persons,provided that any risks which may beassociated with their use constituteacceptable risks when weighed against thebenefits to the patient and are compatiblewith a high level of protection of healthand safety.This sha
5、ll include:ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoComplianc
6、e/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合2.2.The solutions adopted by the manufacturerfor the design and construction of thedevices must conform to safety principles,taking account of the generally acknowledgedstate of the art.In selecting the most appropriate solutions,the manufacturer must appl
7、y the followingprinciples in the following order:制造商所采用的医疗器械的设计方法和结构方法必须符合安全准则，符合大众公认的技术声明文件。制造商必须依次采用以下准则以选择最适合的方法：ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/E
8、C07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合eliminate or reduce risks as far aspossible(inherently safe design andconstruction),尽可能地消除或降低风险（固有安全设计和结构）ApplicableApplicableRequirementsRequirementsS
9、tandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合where approp
10、riate take adequate protectionmeasures including alarms if necessary,inrelation to risks that cannot beeliminated,有关风险不能被消除时，应采取适当的防护措施，必要时包括安装警报装置。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MD
11、D(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合inform users of the residual risks due toany shortcomings of the protectionmeasures adopted.把采取了安全措施后仍然可能存在的风险告知给使用者。Ap
12、plicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制
13、造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合3.3.The devices must achieve the performancesintended by the manufacturer and bedesigned,manufactured and packaged in sucha way that they are suitable for one or moreof the functions referred to in Article 1(2)(a),as specified by the manufacturer.制造商所设计的医疗器械必须达到预期的性能，并
14、且其设计、生产和包装必须符合条款 1（2）（a），由制造商规定的至少一项功能。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/Fail
15、FailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合4.4.The characteristics and performancesreferred to in sections 1,2 and 3 must notbe adversely affected to such a degree thatthe clinical condition and safety of thepatients and,where applicable,of otherpersons are compromised d
16、uring the lifetimeof the device as indicated by themanufacturer,when the device is subjectedto the stresses which can occur duringnormal conditions of use.涉及条款 1,2 和 3 的产品的特征和性能在制造商所指明的产品有效期内、在正常使用条件下受到挤压时必须不影响临床状况、患者安全以及其他人员的安全。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标
17、准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合5.5.The devices must be designed,manuf
18、acturedand packed in such a way that theircharacteristics and performances duringtheir intended use will not be adverselyaffected during transport and storage takingaccount of the instructions and informationprovided by the manufacturer医疗器械的设计、制造和包装在其预期使用过程中其特性和性能不应受到损害，在按制造商提供的说明书和资料进行运输和储存时要保证其特性和
19、性能的完整性。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Re
20、cordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合6.6.Any undesirable side effects must constitutean acceptable risk when weighed against theperformances intended.6a.Demonstration of conformity with theessential requirements must include aclinical evaluation in accordance with AnnexX.当医疗器械的预期性能受到影响时，任何不良副作用必须
21、是可接受的风险。6a.依据附录 X，符合性声明和基本要求中必须含有临床评估。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailF
22、ailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合II.II.REQUIREMENTS REGARDING DESIGN ANDREQUIREMENTS REGARDING DESIGN ANDCONSTRUCTIONCONSTRUCTION设计和结构要设计和结构要求求7.7.Chemical,physical and biological propertiesChemical,physical and biological properties化学性能、物理性能和生物性能化学性能、物理性能和生物性能A
23、pplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds
24、制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合The devices must be designed andmanufactured in such a way as to guaranteethe characteristics and performancesreferred to in Section 1 on the Generalrequirements.Particular attention must bepaid to:医疗器械的设计和制造必须确保其符合“一般要求”中条款 1 所描述的特征和性能。应特别注意：ApplicableApplicableRequi
25、rementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符
26、合/不符合不符合the choice of materials used,particularlyas regards toxicity and,where appropriateflammability,所用物料的选择，尤其要注意其毒性，必要时还要考虑其可燃性。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指
27、令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合the compatibility between the materialsused and biological tissues,cells andbody fluids,taking account of theintended purpose of the de
28、vice.where appropriate,the results ofbiophysical or modelling research whosevalidity has been demonstrated beforehand.根据医疗器械的预期用途，确保其所使用的物料与生物组织、细胞和体液之间的兼容性。必要时，生物或模化研究结果的有效性事先应得到验证。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential
29、Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合The devices must be designed,manufacturedand packed in such a way as to minimise ther
30、isk posed by contaminants and residues tothe persons involved in the transport,storage and use of the devices and to thepatients,taking account of the intendedpurpose of the product.Particular attentionmust be paid to the tissues exposed and theduration and frequency of the exposure.考虑到医疗器械的预期用途，医疗器
31、械的设计、制造和包装必须使污染物和残余物质对在运输、存储和使用过程中所涉及到的人员和患者所造成的风险降低到最低。尤其要注意暴露组织、持续时间和暴露频率。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否
32、）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合The devices must be designed andmanufactured in such a way that they can beused safely with the materials,substancesand gases with which they enter into contactduring their normal use or duri
33、ng routineprocedures;if the devices are intended toadminister medicinal products they must bedesigned and manufactured in such a way asto be compatible with the medicinal productsconcerned according to the provisions andrestrictions governing those products andthat their performance is maintained in
34、accordance with the intended use.医疗器械的设计和制造必须确保其所使用的物料、物质和气体在正常使用或惯常使用情况下能安全使用。如果医疗器械用于施用医疗产品，其设计和制ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要
35、求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合Where a device incorporates,as an integralpart,a substance which,if used separately,may be considered to be a medicinal productas defined in Article 1 of Directive2001/
36、83/EC and which is liable to act uponthe body with action ancillary to that ofthe device,the quality,safety andusefulness of the substance must be verifiedby analogy with the methods specified inAnnex I to Directive 2001/83/EC.当医疗器械组合成一个整体部件，其组合所使用的物质在单独使用时按照 2001/83EC 指令中章节 1 的规定可视作医疗产品，当作用于人体时，该物质
37、在医疗器械组合部件中起辅助作用，必须根据2001/83/EC 指令附录 1 中规定的方法类似的方法对物质的质量、安全和效用进行验证。ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）Manufactu
38、rersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合Where a device incorporates,as an integralpart,a human blood derivative,the notifiedbody shall,having verified the usefulnessof the substance as part of the medicaldevice and taking into account the in
39、tendedpurpose of the device,seek a scientificopinion from the EMEA,acting particularlythrough its committee,on the quality andsafety of the substance including theclinical benefit/risk profile of theincorporation of the human blood derivativeinto the device.当医疗器械组合成一个整体部件，一个人体血液衍生物，报告主体应对视作医疗产品组成部分的
40、物质的效用进行验证并考虑到医疗器械的预期用途，关于物质的质量和安全，包括物质组合成医疗器械后ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/
41、Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合Where changes are made to an ancillarysubstance incorporated in a device,inparticular related to its manufacturingprocess,the notified body shall be informedof the changes and shall consult therelevant medicines competent
42、 authority.theone involved in the initial consultation),in order to confirm that the quality andsafety of the ancillary substance aremaintained.当组合到医疗器械的辅助性物质发生变化时，特别是与之相关的制造过程发生变化时，应把这些变化通知到报告主体且咨询相关医疗权威机构（例如首次咨询的机构），以确保辅助性物质的质量和安全得到保持。ApplicableApplicableRequirementsRequirementsStandardStandard 所符
43、合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合The devices must be designed a
44、ndmanufactured in such a way as to reduce to aminimum the risks posed by substancesleaking from the device.Special attentionshall be given to substances which arecarcinogenic,mutagenic or toxic toreproduction,in accordance with Annex I toCouncil Directive 67/548/EEC of 27 June 1967on the approximati
45、on of laws,regulationsand administrative provisions relating tothe classification,packaging and labellingof dangerous substances(*).If parts of adevice(or a device itself)intended toadminister and/or remove medicines,bodyliquids or other substances to or from thebody,or devices intended for transpor
46、t andstorage of such body fluids or substances,ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk
47、/Ok/FailFailCompliance/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合If the intended use of such devices includestreatment of children or treatment ofpregnant or nursing women,the manufacturermust provide a specific justification forthe use of these substances with regard tocompliance wit
48、h the essential requirements,in particular of this paragraph,within thetechnical documentation and,within theinstructions for use,information onresidual risks for these patient groups and,if applicable,on appropriate precautionarymeasures当医疗器械的使用对象包括儿童或孕妇或哺乳妇女，制造商必须提供使用这些物质的详细理由及其所符合的基本要求，特别是本节要求，所要
49、提供的资料包括技术性文件、使用说明书、残余风险相关ApplicableApplicableRequirementsRequirementsStandardStandard 所符合的标所符合的标准要求准要求 Essential Requirements of the Essential Requirements of theMDD(07/47/EC)MDD(07/47/EC)医疗器械指令（医疗器械指令（07/47/EC07/47/EC）基本要求基本要求(Y/N)(Y/N)适用适用（是（是/否）否）ManufacturersManufacturersOk/Ok/FailFailCompliance
50、/RecoCompliance/Recordsrds制造商符制造商符合性文件合性文件/记录记录符合符合/不符合不符合The devices must be designed andmanufactured in such a way as to reduce asmuch as possible,risks posed by theunintentional ingress of substances into thedevice taking into account the device andthe nature of the environment in which it isinte