基于47EC法規(guī)的基本要求檢查表

1、 基于200747ec法規(guī)的基本要求檢查表93/42/eec including 2007/47/ecannex iessential requirements checklist93/42/eec 包括 2007/47/ec附錄一 基本要求檢查表 product name: ultrasonic scaler產(chǎn)品名： type(s)/model(s): k08類型/型號(hào)product group: ultrasonic scaler; handpiece; scaler tip;產(chǎn)品族issue date of technical file: 技術(shù)文檔發(fā)布日： revision of tec

2、hnical file: 技術(shù)文檔修訂版本： legal manufacturer: 法定制造商 name 名字 street 街道 postal code郵編 place地點(diǎn) country 國(guó)家accessories: 附件：date 日期 name reviewer 1/審核人1的名字 signature reviewer 1/審核人1簽字date日期 name reviewer 2/審核人2的名字 signature reviewer 2/審核人2簽字checklist according to annex i of the medical device directive (mdd)

3、 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standards, other directives and other rules applied by manufacturer制造商引用的標(biāo)準(zhǔn)，其它指令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability)支持性文件(測(cè)試報(bào)告，方案，文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body)

4、要求滿足(由公告機(jī)構(gòu)填寫)ok /fail符合 /不符合i.general requirements通用 要 求1.the devices must be designed and manufactured in such a way that, when used under 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, w

5、here applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.器械的生產(chǎn)和設(shè)計(jì)必須保證：按照其預(yù)定用途和條件使用，器械不會(huì)損害臨床條件、或患者安全、或操作者

6、或其他人員的安全和健康；假設(shè)與器械預(yù)期用途相關(guān)的任何風(fēng)險(xiǎn)，與之給患者帶來(lái)的益處相比，并與健康安全的保護(hù)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 ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and consideration of the tec

7、hnical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).應(yīng)包括： 盡可能地降低由于器械的人體工學(xué)特征和器械預(yù)期使用的環(huán)境（為患者安全設(shè)計(jì)的）的錯(cuò)誤使用而產(chǎn)生的風(fēng)險(xiǎn)， 和 考慮技術(shù)知識(shí)、經(jīng)驗(yàn)、教育和培訓(xùn)，預(yù)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。checklis

8、t 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standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)

9、或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合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 acknowledged state of the art.in selecting

10、the most appropriate solutions, the manufacturer must apply the following principles in the following order: eliminate or reduce risks as far as possible (inherently safe design and construction), where appropriate take adequate protection measures including alarms if necessary, in relation to risks

11、 that cannot be eliminated, inform users of the residual risks due to any shortcomings of the protection measures adopted.制造商采用的器械結(jié)構(gòu)和設(shè)計(jì)方案，必須考慮在當(dāng)前工藝技術(shù)條件下遵守安全原則。在選擇最合適方案時(shí)，制造商應(yīng)按照以下順序遵守原則： 盡可能地降低或避免風(fēng)險(xiǎn)（固有的安全設(shè)計(jì)和結(jié)構(gòu)） 對(duì)無(wú)法避免的風(fēng)險(xiǎn)，如適用，采取適當(dāng)?shù)姆雷o(hù)措施，包括必要的報(bào)警。 告知用戶由于所提供防護(hù)措施的缺陷而帶來(lái)的殘留風(fēng)險(xiǎn)。3. the devices must achieve the pe

12、rformances 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 manufacturer. 器械最后必須取得制造商期望獲得的功能。器械設(shè)計(jì)、制造和包裝應(yīng)與第1條(2)(a)制造商所規(guī)定的一項(xiàng)或多項(xiàng)功能相適應(yīng)。checklist according t

13、o 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standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requi

14、rements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合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 pers

15、ons are compromised during 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. 在制造商確定的器械使用壽命期內(nèi)，在正常使用可能出現(xiàn)的壓力下，第1，2，3款指的各項(xiàng)特征和性能應(yīng)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 an

16、d packed in such a way that 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. 器械設(shè)計(jì)、生產(chǎn)和包裝應(yīng)當(dāng)保證器械的特征和性能在運(yùn)輸和儲(chǔ)存過(guò)程中，只要遵守制造商提供的有關(guān)說(shuō)明和信息，就不會(huì)受到重大影響。6. any

17、 undesirable side effects must constitute an acceptable risk when weighed against the performances intended. 副作用的大小同器械的預(yù)期性能相比，是可接受的風(fēng)險(xiǎn)。 6a. demonstration of conformity with the essential requirements must include a clinical 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(píng)估 checklist accor

18、ding 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standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由

19、)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合ii. requirements regarding design and construction 設(shè)計(jì)和結(jié)構(gòu)的要求7. chemical, physical and biological properties 化學(xué)、物理和生物特征 7.1 the devices must be designed and manufactured in such a way as to guarantee the charac

20、teristics and performances referred to in section 1 on the general requirements. particular attention must be paid to: the choice of materials used, particularly as regards toxicity and, where appropriate flammability, the compatibility between the materials used and biological tissues, cells and bo

21、dy fluids, taking account of the intended purpose of the device. where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand. 器械的設(shè)計(jì)和生產(chǎn)必須保證達(dá)到本附錄第i部分的通用要求，另外應(yīng)特別注意： 合理選擇原料，特別是易燃物質(zhì)和有毒物質(zhì)的選擇； 從器械預(yù)定功能出發(fā)考慮所選材料同人體生物組織、細(xì)胞和體液的相容性。 如適用，事先已確認(rèn)有效的生物物理學(xué)或模型研究的結(jié)

22、果7.2 the devices must be designed, manufactured 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 attentio

23、n must be paid to the tissues exposed and the duration and frequency of the exposure.器械的設(shè)計(jì)、制造和包裝應(yīng)當(dāng)保證器械在運(yùn)輸、儲(chǔ)存和使用過(guò)程中的污染和殘留物對(duì)人體危害最低，應(yīng)特別注意觀察暴露于器械下的人體組織及其時(shí)間和頻率。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standards, other direc

24、tives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合7.3 the devices must be designed and m

25、anufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during 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 a

26、s to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use. 器械設(shè)計(jì)和生產(chǎn)必須保證在正常使用和常規(guī)過(guò)程中接觸其它材料、物質(zhì)和氣體不會(huì)影響其安全使用；如果器械需要加載其它藥品，器械的設(shè)計(jì)和生產(chǎn)必須保證同該藥品相兼容，必須考慮法規(guī)對(duì)該藥品的規(guī)定和限制，保

27、證器械達(dá)到預(yù)定功能。7.4 where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product 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

28、 and usefulness of the substance must be verified by analogy with the methods specified in annex i to 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standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)

29、準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合directive 2001/83/ec. 如果某種器械含有某種物質(zhì)作為其組成部分，而且該物質(zhì)單獨(dú)使用時(shí)可被認(rèn)為是2001/83ec第1條含義內(nèi)的藥品，并且它能夠幫助該器械對(duì)人體產(chǎn)生

30、輔助作用，這種物質(zhì)的安全性、質(zhì)量和有效性必須通過(guò)2001/83/ec指令附錄i涉及的適用方法進(jìn)行類推來(lái)確認(rèn)。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 intended purpose of the device, seek a scientific opinion from

31、 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 726/20041 on the quality and safety of the substance including the clinical benefit/risk profile of the incorporat

32、ion of the substance into the device. when issuing its opinion, the competent authority or the 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. 對(duì)于第一段提到的物質(zhì)，在考慮到該器械的預(yù)期用途時(shí)確

33、認(rèn)了該物質(zhì)作為醫(yī)療器械一部分的有效性之后，公告機(jī)構(gòu)應(yīng)按regulation (ec) no 726/20041法規(guī)，就該物質(zhì)的質(zhì)量和安全性包括該物質(zhì)與器械整合的臨床受益/風(fēng)險(xiǎn)特性，向成員國(guó)指定的一個(gè)主管當(dāng)局或歐洲藥品評(píng)價(jià)署（emea）特別是其委員會(huì)尋求科學(xué)意見(jiàn)。當(dāng)發(fā)表其意見(jiàn)時(shí)，主管當(dāng)局或emea應(yīng)考慮公告機(jī)構(gòu)認(rèn)定的關(guān)于該物質(zhì)與器械整合有效性的生產(chǎn)過(guò)程和數(shù)據(jù)。1 regulation (ec) no 726/2004 of the european parliament and of the council of 31 march 2004 laying down community proce

34、dures 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) no 1901/2006.checklist according to annex i of the medical device directive (mdd) 按醫(yī)

35、療 器 械 指 令 （mdd） 附 錄 一 的 基 本 要 求 檢 查 表 a/ na 適用/ 不適用standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified bod

36、y) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合where a device incorporates, as an integral part, a human blood 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

37、from the emea, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. when issuing this opinion, the emea shall take into account the manufacturing process a

38、nd the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. 如果某種器械含有人血制品作為其組成部分，在確認(rèn)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(yù)期用途的基礎(chǔ)上，公告機(jī)構(gòu)應(yīng)就該制品的質(zhì)量和安全性包括該制品與器械整合的臨床受益/風(fēng)險(xiǎn)特性，向歐洲藥品評(píng)價(jià)署（emea）特別是其委員會(huì)尋求科學(xué)意見(jiàn)。當(dāng)發(fā)表其意見(jiàn)時(shí)，主管當(dāng)局或emea應(yīng)考慮公告機(jī)構(gòu)認(rèn)定的關(guān)于該物質(zhì)與器械整合有效性的生產(chǎn)過(guò)程和數(shù)據(jù)。whe

39、re changes are made to an ancillary substance incorporated in a device, in particular 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

40、 confirm that the quality and safety of the ancillary substance are maintained. 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 order to ensure that the changes have no negativ

41、e impact on the established benefit/risk profile of the addition of the substance in the medical device. 如果器械整合的輔助物質(zhì)發(fā)生了變更，特別是關(guān)系到其生產(chǎn)過(guò)程，公告機(jī)構(gòu)應(yīng)被通知并向相關(guān)的藥品主管當(dāng)局（也 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standards, other dire

42、ctives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合就是最初的咨詢機(jī)構(gòu)）咨詢，以確認(rèn)輔助物質(zhì)的質(zhì)量和安全性得以維持。主管當(dāng)局應(yīng)

43、考慮公告機(jī)構(gòu)認(rèn)定的關(guān)于該物質(zhì)與器械整合有效性的數(shù)據(jù)，以確保這種變更對(duì)已經(jīng)建立的醫(yī)療器械中的增加物質(zhì)的臨床受益/風(fēng)險(xiǎn)特性沒(méi)有負(fù)面影響。when the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the additio

44、n of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. the notified body shall take the updated scientific opinion into acc

45、ount in reconsidering its assessment of the conformity assessment procedure. 當(dāng)相關(guān)的藥品主管當(dāng)局（也就是最初的咨詢機(jī)構(gòu)）得到關(guān)于輔助物質(zhì)對(duì)已經(jīng)建立的醫(yī)療器械中的增加物質(zhì)的臨床受益/風(fēng)險(xiǎn)特性有影響的信息后，應(yīng)向公告機(jī)構(gòu)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(zhì)的臨床受益/風(fēng)險(xiǎn)特性。公告機(jī)構(gòu)應(yīng)考慮到更新的科學(xué)意見(jiàn)，以重新考慮對(duì)符合性評(píng)價(jià)程序的評(píng)價(jià)。7.5 the devices must be designed and manufactured in such a way as to reduce to a m

46、inimum the risks posed by substances leaking from the 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/eec2 of 27 june 1967 on the approximation of laws, regulations and administr

47、ative provisions relating to the classification 2 internal note: replaced by (ec) 1272/2008 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standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則

48、documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 / 不符合packaging and labelling of dangerous substances3. 器械的設(shè)計(jì)和制造，必須將源自器械的物質(zhì)泄漏的風(fēng)險(xiǎn)降至最低。應(yīng)當(dāng)特別注意按1967年6月27日成員國(guó)法律

49、中67/548/eec2委員會(huì)指令附錄i界定的致癌物、誘基因突變物和生殖毒性物質(zhì)相關(guān)的危險(xiǎn)物質(zhì)3對(duì)分類、包裝和標(biāo)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 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, cont

50、ain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with annex i to directive 67/548/eec2, 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

51、 a device containing phthalates. 如果器械的一部分（或器械本身）預(yù)期用于對(duì)身體給藥或除藥、體液或其它物質(zhì)，或預(yù)期用于運(yùn)輸或存儲(chǔ)這些體液或物質(zhì)，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(zhì)的鄰苯二甲酸鹽，該器械必須在自身和/或每臺(tái)的包裝上作出標(biāo)識(shí)，及適當(dāng)時(shí)在器械的銷售包裝上作出含有鄰苯二甲酸鹽的標(biāo)識(shí)。if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, t

52、he manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient g

53、roups and, if applicable, on appropriate3 oj 196, 16.8.1967, p. 1. directive as last amended by directive 2006/121/ec of the european parliament and of the council (oj l 396, 30.12.2006, p. 850). 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

54、檢 查 表 a/ na 適用/ 不適用standards, other directives and other rules applied by manufacturer 制造商引用的標(biāo)準(zhǔn)，其它指 令或規(guī)則documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(測(cè)試報(bào)告，方案， 文獻(xiàn)或不適用的理由)requirements fulfilled ( to be filled in by notified body) 要求滿足 (由公告機(jī)構(gòu)填寫)ok / fail 符合 /

55、不符合precautionary measures. 如果器械的預(yù)期用途包括對(duì)兒童、孕婦或哺乳期婦女的治療，制造商必須在技術(shù)文檔和使用說(shuō)明書中提供具體的使用這些物質(zhì)的理由，及關(guān)于對(duì)這些患者群的殘留風(fēng)險(xiǎn)，如適用，和合適的防范措施等信息，以符合基本要求，特別是本條的要求。7.6 the 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 devi

56、ce taking into account the device and the nature of the environment in which it is intended to be used. 考慮到器械和預(yù)期使用的環(huán)境，器械的設(shè)計(jì)和生產(chǎn)必須保證，最大限度地降低由于異物進(jìn)入而造成危害的可能性。8. infection and microbial contamination 感染和微生物污染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, w