1、精選優質文檔-傾情為你奉上 Essential Requirements of the MDD (07/47/EC) 醫療器械指令（07/47/EC）基本要求Applicable(Y/N)適用（是/否）Requirements Standard 所符合的標準要求ManufacturersCompliance/Records 制造商符合性文件/記錄Ok / Fail符合/不符合 I.GENERAL REQUIREMENTS基本要求1.The devices must be designed and manufactured in such a way that, when used under

2、the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed agai

3、nst the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patie

4、nt safety), and consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).必須確保醫療器械的設計和制造在使用時或將被使用時不危害臨床狀況或不傷害到患者的健康，或使用者或其他人員的健康和安全，在產品使用過程中產生的與患者利益相關

5、的風險應是可接受的且符合高級別的健康安全防護措施。應包括以下內容：盡可能地降低由于醫療器械的性能特征及其使用時所處的環境（為患者安全所設計）而導致的使用錯誤風險。考慮技術知識、經驗、教育及培訓程度、使用者的醫療條件和物理條件（為非專業人士、專業人士、殘疾人士及其它使用者所設計）。2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally ac

6、knowledged state of the art.In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:制造商所采用的醫療器械的設計方法和結構方法必須符合安全準則，符合大眾公認的技術聲明文件。制造商必須依次采用以下準則以選擇最適合的方法：· eliminate or reduce risks as far as possible (inherently safe design and cons

7、truction),· 盡可能地消除或降低風險（固有安全設計和結構）· where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,· 有關風險不能被消除時，應采取適當的防護措施，必要時包括安裝警報裝置。· inform users of the residual risks due to any shortcomings of the protection

8、 measures adopted.· 把采取了安全措施后仍然可能存在的風險告知給使用者。3.The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufactur

9、er.制造商所設計的醫療器械必須達到預期的性能，并且其設計、生產和包裝必須符合條款1（2）（a），由制造商規定的至少一項功能。4.The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromised duri

10、ng the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.涉及條款1,2和3的產品的特征和性能在制造商所指明的產品有效期內、在正常使用條件下受到擠壓時必須不影響臨床狀況、患者安全以及其他人員的安全。5.The devices must be designed, manufactured and packed in such a way tha

11、t their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer醫療器械的設計、制造和包裝在其預期使用過程中其特性和性能不應受到損害，在按制造商提供的說明書和資料進行運輸和儲存時要保證其特性和性能的完整性。6.Any undesirable side

12、effects must constitute an acceptable risk when weighed against the performances intended.6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.當醫療器械的預期性能受到影響時，任何不良副作用必須是可接受的風險。6a.依據附錄X，符合性聲明和基本要求中必須含有臨床評估。II.REQUIREMENTS REGARD

13、ING DESIGN AND CONSTRUCTION 設計和結構要求7. Chemical, physical and biological properties 化學性能、物理性能和生物性能7.1The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section 1 on the "General requirements". Particular attention

14、must be paid to:醫療器械的設計和制造必須確保其符合“一般要求”中條款1所描述的特征和性能。應特別注意：· the choice of materials used, particularly as regards toxicity and, where appropriate flammability,· 所用物料的選擇，尤其要注意其毒性，必要時還要考慮其可燃性。· the compatibility between the materials used and biological tissues, cells and body fluids,

15、taking account of the intended purpose of the device.· where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.· 根據醫療器械的預期用途，確保其所使用的物料與生物組織、細胞和體液之間的兼容性。· 必要時，生物或模化研究結果的有效性事先應得到驗證。7.2The devices must be designed, manufactured

16、and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and the du

17、ration and frequency of the exposure.考慮到醫療器械的預期用途，醫療器械的設計、制造和包裝必須使污染物和殘余物質對在運輸、存儲和使用過程中所涉及到的人員和患者所造成的風險降低到最低。尤其要注意暴露組織、持續時間和暴露頻率。7.3The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact dur

18、ing their normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and tha

19、t their performance is maintained in accordance with the intended use.醫療器械的設計和制造必須確保其所使用的物料、物質和氣體在正常使用或慣常使用情況下能安全使用。如果醫療器械用于施用醫療產品，其設計和制造必須符合醫療的相關條款和制度，并按照預期用途保持其性能。7.4Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product

20、 as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/ EC.當醫療器械組合成一個整體部件，其組合所使用的

21、物質在單獨使用時按照2001/83EC指令中章節1的規定可視作醫療產品，當作用于人體時，該物質在醫療器械組合部件中起輔助作用，必須根據2001/83/EC指令附錄 1中規定的方法類似的方法對物質的質量、安全和效用進行驗證。 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 device and taking account of the inte

22、nded purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the substance

23、including the clinical benefit/risk profile of the incorporation of the substance into the device. 關于第一段中所提到的物質，根據第726/2004號規則（1）中的規定，報告主體應對視作醫療產品組成部分的物質的效用進行驗證并考慮到醫療器械的預期用途，關于物質的質量和安全，包括物質組合成醫療器械后產生的臨床效益和風險，應通過其委員會尋求來自成員國或歐洲醫療代理機構指定的權威機構的科學觀點。When issuing its opinion, the competent authority or the

24、 EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. 當提出觀點時，權威機構或歐洲醫療代理機構應把報告主體所規定的制造過程和物質組合成醫療器械后的相關效用數據考慮在內。Where a device incorporates, as an integral part, a human bloo

25、d derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substa

26、nce including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. 當醫療器械組合成一個整體部件，一個人體血液衍生物，報告主體應對視作醫療產品組成部分的物質的效用進行驗證并考慮到醫療器械的預期用途，關于物質的質量和安全，包括物質組合成醫療器械后產生的臨床效益和風險，應通過其委員會尋求來自成員國或歐洲醫療代理機構指定的權威機構的科學觀點。When issuing its opinion, the EMEA shall take int

27、o account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.當提出觀點時，權威機構或歐洲醫療代理機構應把報告主體所規定的制造過程和物質組合成醫療器械后的相關效用數據考慮在內。Where changes are made to an ancillary substance incorporated in a device, in parti

28、cular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation) , in order to confirm that the quality and safety of the ancillary substance are maintained.

29、當組合到醫療器械的輔助性物質發生變化時，特別是與之相關的制造過程發生變化時，應把這些變化通知到報告主體且咨詢相關醫療權威機構（例如首次咨詢的機構），以確保輔助性物質的質量和安全得到保持。The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in ()Regulation (EC) No 726/2004 of th

30、e European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) . Regulation as last amended by Regulation (EC)

31、 No 1901/2006.根據歐洲議會制定的第726/2004號（EC）規定第（*）條款和和歐洲委員會2004年3月31日制定的關于用于人類和動物的醫療產品的授權和監督程序以及建立歐洲醫療代理機構（OJL 136，30.4.2004，p.1)的決議，權威機構應把報告主體所規定的制造過程和物質組合成醫療器械后的相關效用數據考慮在內。7.5The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from t

32、he device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, pac

33、kaging and labelling of dangerous substances (*) . If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which

34、 are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing

35、phthalates.醫療器械的設計和制造必須確保由于醫療器械的物質泄漏所引起的風險降低到最小值。根據1967年6月27日制定的67/548/EEC指令附錄1中的規定以及其它相關的法規、規章和管理規定中關于危險物質的分類、包裝和貼標，要特別注意致癌物質、誘導有機體突變的物質或影響生殖的有毒物質。當醫療器械的部件（或醫療器械本身）用于向人體施用和/或移除來自人體的藥物、體液或其它物質，或用于運輸和存儲這些體液或物質，包括根據67/548/EEC指令附錄I中目錄1或目錄2被歸類為致癌物質、誘導有機體突變的物質或影響生殖的有毒物質的鄰苯二甲酸鹽，必須在醫療器械產品上和/或在每一個包裝上或必要時在其銷

36、售包裝上貼上標簽，表明其含有鄰苯二甲酸鹽。If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this p

37、aragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures當醫療器械的使用對象包括兒童或孕婦或哺乳婦女，制造商必須提供使用這些物質的詳細理由及其所符合的基本要求，特別是本節要求，所要提供的資料包括技術性文件、使用說明書、殘余風險相關信息，若可以，應提供相關預防措施。7

38、.6The devices must be designed and manufactured in such a way as to reduce as much as possible, risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.考慮到醫療器械及其預期使用的環境特性，醫療器械的設計和制造必須盡可

39、能的降低由于外來物質進入醫療器械所造成的風險。8.Infection and microbial contamination病毒傳染和微生物污染8.1 The devices and their manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and,

40、 where necessary, minimise contamination of the device by the patient or vice versa during use.醫療器械及其生產過程的設計必須盡可能的消除或降低患者、使用者和第三方被傳染的風險。醫療器械的設計必須易于操作，必要時，降低醫療器械在使用過程中被患者污染的程度或醫療器械對患者的污染程度。8.2Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surv

41、eillance adapted to the intended use of the tissues.動物組織必須來源于組織的預期用途由獸醫控制和監督的動物。Notified Bodies shall retain information on the geographical origin of the animals.認證主體應保留動物原產地相關信息。Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so

42、as to provide optimal security. In particular safety with regard to viruses and other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.對動物組織、細胞和物質進行加工、存儲、測試和處理時必須能夠確保其最佳安全性。特別是在生產加工過程中，必須通過執行有

43、效的根除或滅菌方法對病毒和其它可傳播媒介進行處理。8.3Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down,

44、until the protective packaging is damaged or opened.以無菌形式提供的醫療器械的設計、制造和包裝必須采用一次性包裝，并且/或根據適當的程序確保其在規定的存儲和運輸條件下在上市時是無菌的并繼續有效，直到其包裝受損或被拆開。8.4Devices delivered in a sterile state must have been manufactured and sterilised by an appropriate, validated method.以無菌形式提供的醫療器械必須采用適當的、經認可的方法進行生產和滅菌。8.5Devices i

45、ntended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) conditions.無菌醫療器械的制造必須在有適當控制的（例如：環境控制）條件中進行。8.6Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be ste

46、rilised prior to use, minimise the risk of microbial contamination. The packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer.非無菌醫療器械的包裝系統必須確保產品在所規定的潔凈水平下沒有變質，醫療器械在使用前要消毒以降低微生物污染風險。包裝系統必須適當考慮制造商所指定的消毒方法。8.7The packaging and/or label of the devi

47、ce must distinguish between identical or similar products sold in both sterile and non-sterile condition.包裝和/或標簽必須能夠區分以無菌狀態或非無菌狀態銷售的同類產品或相似產品。9.Construction and environmental properties結構和環境特性9.1If the device is intended for use in combination with other devices or equipment, the whole combination,

48、including the connection system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or in the instruction for use.如果醫療器械與其它醫療器械或儀器結合使用，那么整個組合體、包括連接系統必須安全且不損害該醫療器械的特有性能。任何使用限制必須在標簽或使用說明書中標明。9.2Devices must be designed and m

49、anufactured in such a way as to remove or minimise as far as possible:醫療器械的設計和制造必須盡可能消除或減少：· the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional, and where appropriate the ergonomic features,· 由其物理特性，包括體積/壓力，尺寸，必要時還包括人體工程特性所引起的受傷

50、風險。· risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure, and acceleration,· 與一定的可預見性環境條件，例如磁場、外部電力影響，靜電放電，氣壓，溫度或壓力變化和加速度有關的風險。· the risk

51、s of reciprocal interference with other devices normally used in the investigations or for the treatment given,· 與通常用于研究或治療的其它醫療器械發生相互干擾的風險。· risks arising where maintenance or calibration are not possible (as with implants) from ageing of the materials used or loss of accuracy of any meas

52、uring or control mechanism.· 在不可能進行維修保養或校準（當移植時）時，由于所使用的物料老化或任何測量失準或操作不當所產生的風險。9.3Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended us

53、e includes exposure to flammable substances which could cause combustion.醫療器械的設計和制造必須能夠降低在其正常使用過程中和出現單一故障時所產生的火災風險或爆炸風險。應特別注意含有在使用時由于曝光而可能引起燃燒的易燃物質的醫療器械。10.Devices with a measuring function具有測量功能的醫療器械10.1Devices with a measuring function must be designed and manufactured in such a way as to provide

54、sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.具有測量功能的醫療器械的設計和制造應考慮其預期用途，并確保其在適當的精確限制值范圍內具有高精確度和穩定性。制造商必須指明精確度范圍。10.2The measurement, monitoring and display

55、 scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.考慮到醫療器械的預期用途，測量、監測和顯示刻度的設計必須符合人類工程學原理。10.3The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/1

56、81/EEC (OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28).具有測量功能的醫療器械的測量必須用 80/181/EEC 指令(OJ No L 39, 15. 2. 1980, p. 40. 由 89/617/EEC 指令(OJ No L 357, 7. 12. 1989, p. 28)修訂而來）所規定的法定單位表示。11.Protection against radiation輻射防護Gen

57、eral總則Devices shall be designed and manufactured such that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes. 在未對輻射用于治療和診斷時的標準進行規定時，醫療器械的設計和制造應盡可能的避免患者、使用者和其他人員受到過多的輻射。Intended radiation預期輻射Where devices are designed to emit hazardous levels of radiation necessary for a specific medic