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1、Checklist according to annex I of the Medical Device Directive(MDD)按 醫(yī) 療 器 械 指 令（MDD）附 錄 一 的 基 本 要 求 檢 查 表A/NA 適用/不適用I.General Requirements通 用 要 求1.The devices must be designed and manufactured in such a way that,whenused under the conditions and for the purposes intended,they will notcompromise the

2、 clinical condition or the safety of patients,or the safety andhealth of users or,where applicable,other persons,provided that any riskswhich may be associated with their intended use constitute acceptable riskswhen weighed against the benefits to the patient and are compatible with ahigh level of p

3、rotection of health and safety.器械的生產和設計必須保證：按照其預定用途和條件使 用，器械不會損害臨床條件、或患者安全、或操作者或其 他人員的安全和健康；假設與器械預期用途相關的任何風 險，與之給患者帶來的益處相比，并與健康安全的保護程 度相一致，則是可接受的。This shall include:reducing,as far as possible,the risk of use error due to the ergonomicfeatures of the device and the environment in which the device is

4、 intended tobe used(design for patient safety),and consideration of the technical knowledge,experience,education andtraining and where applicable the medical and physical conditions of intendedusers(design for lay,professional,disabled or other users).應包括：盡可能地降低由于器械的人體工學特征和器械預期使用 的環(huán)境（為患者安全設計的）的錯誤使用而

5、產生的風 險，和 考慮技術知識、經(jīng)驗、教育和培訓，預期用戶（為非專 業(yè)人員、專業(yè)人員、傷殘人員或其他人）的醫(yī)療和身體條件。2.The solutions adopted by the manufacturer for the design and construction ofthe devices must conform to safety principles,taking account of the generallyacknowledged state of the art.In selecting the most appropriate solutions,the manufa

6、cturer must apply thefollowing principles in the following order:eliminate or reduce risks as far as possible(inherently safe design andconstruction),where appropriate take adequate protection measures including alarms ifnecessary,in relation to risks that cannot be eliminated,Inform users of the re

7、sidual risks due to any shortcomings of the protectionmeasures adopted.制造商采用的器械結構和設計方案，必須考慮在當前工藝 技術條件下遵守安全原則。在選擇最合適方案時，制造商應按照以下順序遵守原則：盡可能地降低或避免風險（固有的安全設計和結構）對無法避免的風險，如適用，采取適當?shù)姆雷o措施，包 括必要的報警。告知用戶由于所提供防護措施的缺陷而帶來的殘留風 險。3.The devices must achieve the performances intended by the manufacturer andbe design

8、ed,manufactured and packaged in such a way that they are suitablefor one or more of the functions referred to in Article 1(2)(a),as specified bythe manufacturer.器械最后必須取得制造商期望獲得的功能。器械設計、制造和包裝應與第 1 條(2)(a)制造商所規(guī)定的一項或多項功能相適應。4.The characteristics and performances referred to in sections 1,2 and 3 mustno

9、t be adversely affected to such a degree that the clinical condition and safetyof the patients and,where applicable,of other persons are compromisedduring the lifetime of the device as indicated by the manufacturer,when thedevice is subjected to the stresses which can occur during normal conditionso

10、f use.在制造商確定的器械使用壽命期內，在正常使用可能出現(xiàn) 的壓力下，第1，2，3 款指的各項特征和性能應不能影響 臨床條件、危害患者或其它人員的安全。5.The devices must be designed,manufactured and packed in such a way thattheir characteristics and performances during their intended use will not beadversely affected during transport and storage taking account of theinst

11、ructions and information provided by the manufacturer.器械設計、生產和包裝應當保證器械的特征和性能在運輸 和儲存過程中，只要遵守制造商提供的有關說明和信息，就不會受到重大影響。6.Any undesirable side effects must constitute an acceptable risk when weighedagainst the performances intended.副作用的大小同器械的預期性能相比，是可接受的風險。6a.Demonstration of conformity with the essentia

12、l requirements must include aclinical evaluation in accordance with Annex X.證明符合基本要求必須包括按照附錄 X 的臨床評估II.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION設計和結構的要求7.Chemical,physical and biological properties化學、物理和生物特征7.1The devices must be designed and manufactured in such a way as to guaranteethe charac

13、teristics and performances referred to in Section 1 on the Generalrequirements.Particular attention must be paid to:the choice of materials used,particularly as regards toxicity and,whereappropriate flammability,the compatibility between the materials used and biological tissues,cells andbody fluids

14、,taking account of the intended purpose of the device.Where appropriate,the results of biophysical or modelling research whosevalidity has been demonstrated beforehand.器械的設計和生產必須保證達到本附錄第 I 部分的通用要 求，另外應特別注意：合理選擇原料，特別是易燃物質和有毒物質的選擇；從器械預定功能出發(fā)考慮所選材料同人體生物組織、細 胞和體液的相容性。如適用，事先已確認有效的生物物理學或模型研究的結 果7.2The devi

15、ces must be designed,manufactured and packed in such a way as tominimise the risk posed by contaminants and residues to the persons involvedin the transport,storage and use of the devices and to the patients,takingaccount of the intended purpose of the product.Particular attention must bepaid to the

16、 tissues exposed and the duration and frequency of the exposure.器械的設計、制造和包裝應當保證器械在運輸、儲存和使 用過程中的污染和殘留物對人體危害最低，應特別注意觀 察暴露于器械下的人體組織及其時間和頻率。7.3The devices must be designed and manufactured in such a way that they canbe used safely with the materials,substances and gases with which they enterinto contact

17、 during their normal use or during routine procedures;ifthe devices are intended to administer medicinal products they must bedesigned and manufactured in such a way as to be compatible with themedicinal productsconcerned according to the provisions and restrictions governing thoseproducts and that

18、their performance is maintained in accordance with theintended use.器械設計和生產必須保證在正常使用和常規(guī)過程中接觸其 它材料、物質和氣體不會影響其安全使用；如果器械需要 加載其它藥品，器械的設計和生產必須保證同該藥品相兼 容，必須考慮法規(guī)對該藥品的規(guī)定和限制，保證器械達到 預定功能。7.4Where a device incorporates,as an integral part,a substance which,if usedseparately,may be considered to be a medicinal p

19、roduct as defined in Article1 of Directive 2001/83/EC and which is liable to act upon thebody with action ancillary to that of the device,the quality,safety andusefulness of the substance must be verifiedby analogy with the methods specified in Annex I to Directive 2001/83/EC.如果某種器械含有某種物質作為其組成部分，而且該

20、物質 單獨使用時可被認為是 2001/83EC 第 1 條含義內的藥品，并且它能夠幫助該器械對人體產生輔助作用，這種物質的 安全性、質量和有效性必須通過2001/83/EC 指令附錄 I 涉 及的適用方法進行類推來確認。For the substances referred to in the first paragraph,the notified body shall,having verified the usefulness of the substance as part of the medical deviceand taking account of the intended

21、purpose of the device,seek a scientificopinion from one of the competent authorities designated by the MemberStates or the European Medicines Agency(EMEA)acting particularly throughits committee in accordance with Regulation(EC)No726/20041 on the quality and safety of the substanceincluding the clin

22、ical benefit/risk profile of the incorporation of the substanceinto the device.When issuing its opinion,the competent authority or theEMEA shall take into account the manufacturing process and the data relatedto the usefulness of incorporation of the substance into the device asdetermined by the not

23、ified body.對于第一段提到的物質，在考慮到該器械的預期用途時確 認了該物質作為醫(yī)療器械一部分的有效性之后，公告機構應按Regulation(EC)No 726/20041法規(guī)，就該物質的質量 和安全性包括該物質與器械整合的臨床受益/風險特性，向 成員國指定的一個主管當局或歐洲藥品評價署（EMEA）特別是其委員會尋求科學意見。當發(fā)表其意見時，主管當 局或EMEA應考慮公告機構認定的關于該物質與器械整合 有效性的生產過程和數(shù)據(jù)。Where a device incorporates,as an integral part,a human blood derivative,thenotif

24、ied body shall,having verified the usefulness of the substance as part ofthe medical device and taking into account the intended purpose of the device,seek a scientific opinion from the EMEA,acting particularly through itscommittee,on the quality and safety of the substance including the clinicalben

25、efit/risk profile of the incorporation of the human blood derivative into thedevice.When issuing this opinion,the EMEA shall take into account themanufacturing process and the data related to the usefulness of incorporationof the substance into the device as determined by the notified body.如果某種器械含有人

26、血制品作為其組成部分，在確認了該血制品作為醫(yī)療器械一部分的有效性，并考慮到該器械的 預期用途的基礎上，公告機構應就該制品的質量和安全性 包括該制品與器械整合的臨床受益/風險特性，向歐洲藥品 評價署（EMEA）特別是其委員會尋求科學意見。當發(fā)表 其意見時，主管當局或EMEA應考慮公告機構認定的關于 該物質與器械整合有效性的生產過程和數(shù)據(jù)。Where changes are made to an ancillary substance incorporated in a device,inparticular related to its manufacturing process,the not

27、ified body shall beinformed of the changes and shall consult the relevant medicines competentauthority(i.e.the one involved in the initial consultation),in order to confirmthat the qualityand safety of the ancillary substance are maintained.The competent authorityshall take into account the data rel

28、ated to the usefulness of incorporation of thesubstance into the device as determined by the notified body,in order toensure that the changes have no negative impact on the established benefit/riskprofile of the addition of the substance in the medical device.如果器械整合的輔助物質發(fā)生了變更，特別是關系到其生產過程，公告機構應被通知并向相

29、關的藥品主管當局（也就是最初的咨詢機構）咨詢，以確認輔助物質的質量和安全性得以維持。主管當局應考慮公告機構認定的關于該物 質與器械整合有效性的數(shù)據(jù)，以確保這種變更對已經(jīng)建立 的醫(yī)療器械中的增加物質的臨床受益/風險特性沒有負面影 響。When the relevant medicines competent authority(i.e.the one involved in theinitial consultation)has obtained information on the ancillary substance,which could have an impact on the es

30、tablished benefit/risk profile of theaddition of the substance in the medical device,it shall provide the notifiedbody with advice,whether this information has an impact on the establishedbenefit/risk profile of the addition of the substance in the medical device ornot.The notified body shall take t

31、he updated scientific opinion into account inreconsidering its assessment of the conformity assessment procedure.當相關的藥品主管當局（也就是最初的咨詢機構）得到關 于輔助物質對已經(jīng)建立的醫(yī)療器械中的增加物質的臨床受 益/風險特性有影響的信息后，應向公告機構提出建議，該 信息是否影響已經(jīng)建立的醫(yī)療器械中增加物質的臨床受益/風險特性。公告機構應考慮到更新的科學意見，以重新考 慮對符合性評價程序的評價。7.5The devices must be designed and manufac

32、tured in such a way as to reduce toa minimum the risks posed by substances leaking from the device.Specialattention shall be given to substances which are carcinogenic,mutagenic ortoxic to reproduction,in accordance with Annex I to Council Directive67/548/EEC2 of 27 June1967 on the approximation of

33、laws,regulations and administrative provisionsrelating to the classification,packaging and labelling of dangeroussubstances3.器械的設計和制造，必須將源自器械的物質泄漏的風險降 至最低。應當特別注意按1967年6月27日成員國法律中67/548/EEC2委員會指令附錄I界定的致癌物、誘基因突變物和生殖毒性物質相關的危險物質3對分類、包裝和標簽的 法律法規(guī)，行政條款的符合。If parts of a device(or a device itself)intended to

34、 administer and/or removemedicines,body liquids orother substances to or from the body,or devices intended for transport andstorage of such body fluids or substances,contain phthalates which areclassified as carcinogenic,mutagenic or toxic to reproduction,of category 1 or2,in accordance with Annex I

35、 to Directive67/548/EEC2,these devices must be labelled on the device itself and/or on thepackaging for each unit or,where appropriate,on the sales packaging as adevice containing phthalates.如果器械的一部分（或器械本身）預期用于對身體給藥或 除藥、體液或其它物質，或預期用于運輸或存儲這些體液或物質，包含有按67/548/EEC2指令附錄I界定的1類或2類 致癌物、誘基因突變物或生殖毒性物質的鄰苯二甲酸鹽，

36、該器械必須在自身和/或每臺的包裝上作出標識，及適當時 在器械的銷售包裝上作出含有鄰苯二甲酸鹽的標識。If the intended use of such devices includes treatment of children or treatmentof pregnant or nursing women,the manufacturer must provide a specificjustification for the use of these substances with regard to compliance with theessential requirements

37、,in particular of this paragraph,within the technicaldocumentation and,within the instructions for use,information on residualrisks for thesepatient groups and,if applicable,on appropriate precautionary measures.如果器械的預期用途包括對兒童、孕婦或哺乳期婦女的治 療，制造商必須在技術文檔和使用說明書中提供具體的使 用這些物質的理由，及關于對這些患者群的殘留風險，如 適用，和合適的防范措

38、施等信息，以符合基本要求，特別 是本條的要求。7.6The devices must be designed and manufactured in such a way as to reduce asmuch as possible,risks posed by the unintentional ingress of substances intothe device taking into account the device and the nature of the environment inwhich it is intended to be used.考慮到器械和預期使用的環(huán)境

39、，器械的設計和生產必須保 證，最大限度地降低由于異物進入而造成危害的可能性。8.Infection and microbial contamination感染和微生物污染8.1The devices and their manufacturing processes must be designed in such away as to eliminate or reduce as far as possible the risk of infection to thepatient,user and third parties.The design must allow easy handl

40、ing and,where necessary,minimise contamination of the device by the patient or viceversa during use.器械設計和制造工藝應當保證最大限度地降低甚至避免患 者、使用者和其他人員之間交叉感染的可能性；器械應當 操作簡單，必要時，減少患者對器械、器械對患者的接觸 污染。8.2Tissues of animal origin must originate from animals that have been subjectedto veterinary controls and surveillance

41、 adapted to the intended use of thetissues.動物源組織必須從對按組織的預期用途被進行控制和監(jiān)管的動物中取得。Notified Bodies shall retain information on the geographical origin of theanimals.公告機構應保留動物的原生地的信息。Processing,preservation,testing and handling of tissues,cells and substancesof animal origin must be carried out so as to prov

42、ide optimal security.Inparticular safety with regard to viruses and other transmissible agents must beaddressed by implementation of validated methods of elimination or viralinactivation in the course of the manufacturing process.對動物組織、細胞和其它動物源物質的加工、貯存、檢驗 和處理，必須提供最可靠的安全保障。特別是病毒和其它 傳染物質的安全，在生產過程中有采取有

43、效的消除方法或 進行病毒滅活。8.3Devices delivered in a sterile state must be designed,manufactured andpacked in a non-reusable pack and/or according to appropriate procedures toensure they are sterile when placed on the market and remain sterile,under thestorage and transport conditions laid down,until the protec

44、tive packaging isdamaged or opened.無菌器械的設計、生產和包裝應采用一次性使用包裝方 式，并且在一定工作程序下保證器械上市時處于無菌狀 態(tài)，在貯藏、運輸條件下只要包裝不破損或開封，能夠保 持無菌狀態(tài)。8.4Devices delivered in a sterile state must have been manufactured and sterilisedby an appropriate,validated method.無菌器械必須通過專門、有效的方法進行生產和滅菌。8.5Devices intended to be sterilised must

45、be manufactured in appropriatelycontrolled(e.g.environmental)conditions.需要滅菌的器械在專門控制的環(huán)境下生產。8.6Packaging systems for non-sterile devices must keep the product withoutdeterioration at the level of cleanliness stipulated and,if the devices are to besterilised prior to use,minimise the risk of microbial

46、 contamination.Thepackaging system must be suitable taking account of the method ofsterilisation indicated by the manufacturer.非滅菌器械的包裝系統(tǒng)，應當保證產品達到規(guī)定的清潔 度。如果器械需要在使用前滅菌，應減少器械滅菌前微生 物污染的可能性。包裝系統(tǒng)必須適合于制造商所指定的滅 菌方式。8.7The packaging and/or label of the device must distinguish between identical orsimilar pro

47、ducts sold in both sterile and non-sterile condition.相同或相似的產品銷售時處于無菌狀態(tài)還是非無菌狀態(tài)，器械必須具有不同的包裝和/或標簽。9.Construction and environmental properties結構和環(huán)境特征9.1If the device is intended for use in combination with other devices orequipment,the whole combination,including the connection system must besafe and mu

48、st not impair the specified performance of the devices.Anyrestrictions on use must be indicated on the label or in the instruction for use.器械如果需要同其它器械或設備配合在一起使用，整個系 統(tǒng)應保證安全，包括聯(lián)接系統(tǒng)必須安全，不得改變器械的預定功能。必須在使用說明或標簽上注明使用限制。9.2Devices must be designed and manufactured in such a way as to remove orminimise as f

49、ar as possible:器械的設計和生產必須盡可能降低或避免：the risk of injury,in connection with their physical features,including thevolume/pressure ratio,dimensional,and where appropriate the ergonomicfeatures,由于器械物理性能特性，如體積壓力比、外觀尺寸、人 體工學，對人體造成傷害的可能性。risks connected with reasonably foreseeable environmental conditions,suc

50、has magnetic fields,external electrical influences,electrostatic discharge,pressure,temperature or variations in pressure,and acceleration,在合理的環(huán)境條件下，如電磁場、外部電子干擾，靜電 放射、大氣壓、氣溫以及壓力變化和加速度等條件下，對人體造成傷害的可能性。the risks of reciprocal interference with other devices normally used in theinvestigations or for th

51、e treatment given,在治療或試用時，同其它器械相互干擾對人體造成傷害 的可能性。risks arising where maintenance or calibration are not possible(as withimplants)from ageing of the materials used or loss of accuracy of anymeasuring or control mechanism.如果無法維修或矯正(如植入人體后),由于材料老化、測 試或控制機能精度不夠，對人體造成傷害的可能性。9.3Devices must be designed and

52、 manufactured in such a way as to minimise therisks of fire or explosion during normal use and in single fault condition.Particular attention must be paid to devices whose intended use includesexposure to flammable substances which could cause combustion.器械的設計和生產必須保證，在正常使用情況下或單一故 障的情況下，器械不至于起火或爆炸。對在

53、暴露于易燃物 質環(huán)境下使用的器械必須給予特別注意。10.Devices with a measuring function具有測量功能的器械10.1Devices with a measuring function must be designed and manufactured insuch a way as to provide sufficient accuracy and stability within appropriatelimits ofaccuracy and taking account of the intended purpose of the device.The

54、limitsof accuracy must be indicated by the manufacturer.檢測器械的設計和生產必須保證足夠的精度和穩(wěn)定性、符 合器械預定功能的要求。制造商必須注明其精度范圍。10.2The measurement,monitoring and display scale must be designed in line withergonomic principles,taking account of the intended purpose of the device.必須根據(jù)器械的預定功能，按照人體工學的原理設計器械 的度量、監(jiān)控和顯示刻度。10.3

55、The measurements made by devices with a measuring function must beexpressed in legal units conforming to the provisions of Council Directive80/181/EEC4.測量器械必須使用法定度量單位，符合理事會法令80/181/EEC4的規(guī)定。11.Protection against radiation輻射保護11.111.1.1General原則Devices shall be designed and manufactured such that expo

56、sure of patients,users and other persons to radiation shall be reduced as far as possiblecompatible with the intended purpose,whilst not restricting the application ofappropriate specified levels for therapeutic and diagnostic purposes.器械的設計和生產必須保證在達到預定功能的情況下，盡 量減少對患者、使用者和其它人員的輻射，但不限制為治 療和診斷疾病使用規(guī)定合理

57、的劑量。11.211.2.1Intended radiation預期的輻射Where devices are designed to emit hazardous levels of radiation necessaryfor a specific medical purpose the benefit of which is considered to outweighthe risks inherent in the emission,it must be possible for the user to controlthe emissions.Such devices shall b

58、e designed and manufactured to ensurereproducibility and tolerance of relevant variable parameters.用于特定醫(yī)療目的，有的器械輻射危害人體健康的射線，這種器械對患者的治療作用同射線相比可以為人們所接 受。器械輻射劑量必須能夠控制，(設計和生產時)必須考 慮其可變參數(shù)的可重復性和容差。11.2.2Where devices are intended to emit potentiallyhazardous,visible and/or invisible radiation,they must be

59、 fitted,wherepracticable,with visual displays and/or audible warnings of such emissions.設計器械發(fā)射危害性射線，不論射線是否可見，都應根據(jù) 實際需要安裝可見的顯示裝置和發(fā)聲的報警裝置，指示射 線的發(fā)射狀態(tài)。11.311.3.1Unintended radiation非預期的輻射Devices shall be designed and manufactured in such a way that exposure ofpatients,users and other persons to the emis

60、sion of unintended,stray orscattered radiation is be reduced as far as possible.器械的設計和制造應當保證，盡量減少對患者，使用者以 及其它人員產生非預期的意外輻射。11.411.4.1Instructions使用說明The operating instructions for devices emitting radiation must give detailedinformation as to the nature of the emitted radiation,means of protecting th

61、epatient and the user and on ways of avoiding misuse and of eliminating therisks inherent in installation.放射性醫(yī)療器械應詳細說明輻射特性、對患者和操作者的 保護措施、任何防止操作錯誤以及消除由于安裝器械帶來 的潛在危險。11.511.5.1Ionising radiation電離輻射Devices intended to emit ionising radiation must be designed andmanufactured in such a way as to ensure

62、that,where practicable,the quantity,geometry and quality of radiation emitted can be varied and controlled takinginto account the intended uses.電離輻射器械的設計和生產必須保證，可以改變和控制電 離輻射的數(shù)量，形狀和質量，滿足預定使用功能的實際需 要。11.5.2Devices emitting ionising radiation intended for diagnostic radiology shall bedesigned and manuf

63、actured in such a way,as to achieve appropriate imageand/or outputquality for the intended medical purpose whilst minimising radiation exposureof the patient and user.診斷用電離輻射器械的設計和生產必須保證，在獲得清晰 圖象、提高輸出質量、達到預定醫(yī)療目的的情況下，盡量 減少對患者和使用者的照射。11.5.3Devices emitting ionising radiation intended for therapeutic r

64、adiology shall bedesigned and manufactured in such a way as to enable reliable monitoring andcontrol of the delivered dose,the beam type and energy and where appropriatethe quality of the radiation.治療用電離輻射器械的設計和生產必須保證，能夠有效地 監(jiān)控照射劑量、離子束類型、能量大小以及離子束的質 量。12.Requirements for medical devices connected to

65、or equipped with an energysource 連接或配備能源的醫(yī)療器械的要求12.1Devices incorporating electronic programmable systems must be designed toensure the repeatability,reliability and performance of these systemsaccording to their intended use.In the event of a single fault condition(in thesystem)appropriate means sh

66、ould be adopted to eliminate or reduce as far aspossible consequent risks帶有可編程系統(tǒng)的器械設計應保證其可重復性、可靠性、滿足預定功能的需要。應當采取必要措施、減少因出現(xiàn)單 一故障狀態(tài)而造成危害的可能性。12.1aFor devices which incorporate software or which are medical software inthemselves,the software must be validated according to the state of the arttaking into account the principles of development lifecycle,risk management,validation and verification.對于合并軟件使用的或本身是醫(yī)療軟件的器械，軟件必須 考慮研發(fā)生命周期、風險管理、確認和驗證的原則，按照 當前的技術發(fā)展水平進行確認。12.2Devices where the safety of the pati