無源醫(yī)療器械技術(shù)文檔和設(shè)計檔案材料指引0001

1、無源醫(yī)療器械技術(shù)文件和設(shè)計文檔指南Whereas the term T“echnical File “ is used for Medical Devices of class I, class IIa and class IIb, the term Desig“n Dossier “ is used for the class III products. 標(biāo)題中的“技術(shù)文件”適用于 I類， IIa類,IIb 類醫(yī)療器械，“設(shè)計文檔”適用于 III類醫(yī)療 器械Technical Files are retained in the premises of the manufacturer or

2、the AuthorizedRepresentative for potential review of Competent Authorities and Notified Body.Part B of the Technical File may be available at the manufacturer only.技術(shù)文件是保留在制造商或授權(quán)代表單位的主管部門和認(rèn)證機(jī)構(gòu)。部分技術(shù)文件B部分只保留在制造商處Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE-M

3、arking of the product (use form Application for CE Conformity Assessment (Product)MED_F_03.03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. Af

4、ter successful review, the Notified Body issues a design examination certificate according to Annex II.4 of the Council Directive certifying compliance with the relevant provisions of Annex I of the MDD.設(shè)計檔案材料已被提交到公告機(jī)構(gòu)用于需要CE 認(rèn)證前的產(chǎn)品審查(用 CE合格評定(產(chǎn)品) MED_F_03.03 規(guī)定的格式)。我們將委派一個項目經(jīng)理，他將委托一個或多個資 深專家審查特定的模塊。

5、 所有專家會直接或通過項目經(jīng)理間接與你接觸，在成功的審查 后，公告機(jī)構(gòu)會按照 MDD法規(guī)附件 I和附件II.4相關(guān)規(guī)定簽發(fā)檢驗證書。Article 5 of the Council Directive describes consideration of the European harmonized standards by the manufacturer in order to demonstrate compliance with the Essential Requirements.This aspect is even more important as International

6、 Standard Organizations have adopted European Norms (and vice versa) and demonstrating compliance with these standards could be very helpful in international mutual recognition of the CE-Marking process.理事會指令 5 描述了制造商要遵守的歐洲統(tǒng)一標(biāo)準(zhǔn)，以證明附合基本要求，這方面更重 要的是為國際標(biāo)準(zhǔn)組織已經(jīng)通過了歐洲規(guī)范(反之亦然)，并且遵守這些標(biāo)準(zhǔn)可能非常 有助于國際的相互承認(rèn)在 CE 認(rèn)證

7、過程中。It is not necessary to include all documents in the Design Dossier which have already been subject to an ISO / EN / MDD Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower level documents.設(shè)計檔案材料不必一定包括那些已經(jīng)提交給 ISO / EN / MDD 審查公告機(jī)構(gòu)的所

8、有的文 檔，例如文檔不必包括質(zhì)量手冊和一些相關(guān)更下層文檔。If the manufacturer of a class III device provides detailed information according to the checklist described below, the requirements of the Directive are appropriately addressed.如果一個類 III 器件制造商提供詳細(xì)的資料按下述清單，該指令的要求得到適當(dāng)處理This is even more important in case a Competent Autho

9、rity or another Notified Body wishes to review the documentation.這樣很重要如果主管部門或其他認(rèn)證機(jī)構(gòu)要審查文件Generally, the information should be provided as conclusions, summaries, reports, tables or flow charts (with reference to the full documentation in the Essential Requirement checklist). 一般的，提供的信息應(yīng)包括結(jié)論，摘要，報告，表或流程

10、圖(參照完整文檔在基本要求 檢查表中)Special care should be taken to ensure that any information is consistent throughout the Design Dossier (e.g. description and variants of the device in different documents; adverse events as stated in the IFU and hazards in normal condition as well as in fault condition in the Ris

11、k Management). 特別應(yīng)注意確保任何信息在整個卷中是一致的 (例如：在不同的文檔中器械的規(guī)格描述； 說明書中不良事件的聲明和在正常情況下的危害，以及在故障情況下的風(fēng)險管理)A complete pagination of the Design Dossier or another type of control mechanism is necessary, e.g. revision control of each section. Two copies of the documentation and an electronic version, if possible are

12、 required to achieve an appropriate review time.設(shè)計檔案材料必須有完整的頁碼控制或者另外形式的控制機(jī)制，例如， 每個章節(jié)的版本控制。 兩份拷貝和一個電子版本，如果可能還需要一個審查時間。In general, design changes described in the MDD (93/42/EEC), Annex II.4.4 shall be reported to the Notified Body (use form Change Notification MED_F_09.04) in order to ensure conformi

13、ty with the requirements defined in the Annex II.4.4 and in order to ensure that the Design Dossiers retained at the Notified Body s archive are completeand up-to-date .一般來說， 設(shè)計更改在 MDD (93/42/EEC), 附肵II.4.4有說明，應(yīng)向公告機(jī)構(gòu)報告確保更 改合適(按 MED_F_09.04 更改通知書格式)。Furthermore at least one sample of the device shoul

14、d be provided. 此外，至少應(yīng)提供一個設(shè)備樣品For all data SI units of measurementshall be used.對于所有 SI單位的測量數(shù)據(jù)應(yīng)得到使用。Important hint: Design Dossiers that accurately conform to the below guidance can be reviewed more efficiently!重要提示： 設(shè)計檔案材料準(zhǔn)確地符合以下指導(dǎo)可以更有效地進(jìn)行審查In this regard it is recommended to compile a Design Dossie

15、r or Technical File as follows 在這方面，建議編制設(shè)計檔案材料或技術(shù)文件如下(也可看 NB-MED/2.5.1 和 GHTF 文檔SG1 (PD)/N011R20: STED):PART A: Technical FileA 部分 技術(shù)文件1. Table of Content 目錄2. Introduction 介紹3. Design Dossier/Technical File Summary Information設(shè)計檔案材料 / 技術(shù)文件摘要信息PART B: Annexes B部分 附件1. Essential Requirements Checklis

16、t基本要求檢查表2. Risk Analysis 風(fēng)險分析3. Drawings, Design -, Product - Specifications 圖紙，設(shè)計 - 產(chǎn)品 - 規(guī)格4. Chemical, Physical and Biological Tests4.1 In Vitro Testing - Preclinical Studies4.2 In Vivo Testing - Preclinical Studies化學(xué)，物理和生物測試 體外試驗 - 臨床前研究 體內(nèi)試驗 - 臨床前研究4.3 Biocompatibility Tests 生物相容性測試4.4 Bio-stabi

17、lity Tests 生物穩(wěn)定性試驗4.5 Microbiological Safety, Animal Origin Tissue微生物安全，動物保護(hù)組織4.6 Drug / medical device combination藥物 /醫(yī)療設(shè)備組合4.7 Blood Derivates, Human Tissue / medical device combination血液衍生物，人體組織 /醫(yī)療設(shè)備組合4.8 Coated Medical Devices 涂層醫(yī)療器械5. Clinical Data臨床資料6. Labels and Instructions for Use 標(biāo)簽和使用說明

18、7. Manufacturing 制造8. Package Qualification and Shelf life包裝和保質(zhì)期9. Sterilization 滅菌10. Conclusion 結(jié)論11. Declaration of Conformity (Draft) 符合性聲明(草稿)PART A: Technical File A 部分 技術(shù)文件1. Table of Content目錄Content of both Parts A and B 目錄包括 A 部分和 B 部分2. Introduction 介紹Revision history of Design Dossier: c

19、hange notifications, revision numbers and approvals of all documents including all amendments.設(shè)計文檔案修訂歷史： 更改通知， 版本號和 批準(zhǔn)的所有文件，包括所有的修訂Regulatory Information 法規(guī)信息o Name, postal address, Notified Body, certifications (valid copies attached!) of: 以下機(jī)構(gòu)的名稱，通訊地址，公告機(jī)構(gòu)，證書(有效的復(fù)的復(fù)印件)the manufacturer (incl. conta

20、ct person) 制造商(包括聯(lián)系人)OEM, critical suppliers, subcontractors (e.g. contract sterilizer) OEM，關(guān)鍵供應(yīng)商，外協(xié)商(例如：合同滅菌商)European Representative (if applicable) 歐盟代表(如果適用)o Product and accessory classification, rule according to MDD, Annex IX and according to ISO 10993-1 Table 1 and 2產(chǎn)品及配件分類：按照 MDD 規(guī)定的附錄 9和IS

21、O10993-1 表1和表2o Conformity Assessment Route 合格評定路徑 Annex II.3+II.4o UMDNS-/GMDS-code UMDNS-/GMDS 編號o Product History: approvals (e.g. FDA 510(k) or PMA clearance), market release,status of any pending request for market clearance; items sold上市銷售歷史，證書，時間，數(shù)量Brief description of the product 產(chǎn)品簡要描述o Int

22、ended use, model names, configurations, variants 產(chǎn)品預(yù)期用途， 型號規(guī)格名稱， 配置和規(guī)格表o Accessories for the product, integral parts of package 產(chǎn)品的附件 , 同一包裝的部件o Applied standards （list or table including the full title, identifying numbers, date, andthe organization that created the standard）適用標(biāo)準(zhǔn)（全名的列標(biāo)，包括編號，日期和該標(biāo)準(zhǔn)的

23、編制機(jī)構(gòu)）特別協(xié)調(diào)標(biāo)準(zhǔn)Note: Please make sure to use current standards only or provide a gap analysisand rationale 注： 請務(wù)必使用唯一最新標(biāo)準(zhǔn)或提供差距分析和理由o Rationale if applicable standards or parts thereof have not been considered如為何沒有采用當(dāng)前標(biāo)準(zhǔn)或部分標(biāo)準(zhǔn)的理由3. Design Dossier / Technical File Summary Information （reference tosupportin

24、g documents filed in Part B）設(shè)計檔案材料 /技術(shù)文件摘要信息（參照 B部分支持文檔）Comprehensive description of the system and each functional component of the device and the related accessories including utilized material or ingredient （animal/human origin, drug device combination?）, packaging, method of sterilization, shelf

25、 life, combination with active medical devices. The description should be supported by diagrams, photographs or drawings, as appropriate. 綜合描述：整個系統(tǒng)的（包括包裝），產(chǎn)品的每個功能部件和相關(guān)的附件包括關(guān)鍵材料 或組成部分（動物/人類,藥物組合裝置 ）,包裝,滅菌方法,有效期,配合使用的有源醫(yī)療器械 , 描述應(yīng)有適用的簡圖 ,照片或工程圖 .Basic scientific concepts that form the fundamentals for

26、the device including medical, biological, chemical, and physical background information 產(chǎn)品依據(jù)的基本的科學(xué)概念 ,包括材料 ,生物 ,化學(xué)和物理背景資料 .In case of a Change Notification: description of all changes in comparison with the previous design or manufacturing process （e.g. tabular format） 更改通知 : 所有的變化描述與先前的設(shè)計或制造過程中的比較

27、（例如:列表的格式 ）Summary of the essential data and results as detailed in Part B B部分中關(guān)鍵數(shù)據(jù)和結(jié)果摘要Information as provided in the Instructions / Directions for Use （detailed in section B）: Intended Use, Indication, Contraindications, Warnings, Adverse events, Operation and use of accessories 使用說明提供的信息 :使用指導(dǎo)（詳細(xì)

28、見B部分）,用途,標(biāo)志,禁忌,警告,不良反應(yīng), 操作和使 用的配件Planned changes 計劃中的改變（規(guī)格型號）Summary description of manufacturing process簡要介紹制造過程Any other important safety/performance related information.任何其他重要的安全特性 :性能相關(guān)的信息This structure enables efficient project planning and management. Part A can be used for a pre-review in ord

29、er to instantly notify the manufacturer of open issues or in caseparticular aspects are not covered in the Design Dossier. 這種結(jié)構(gòu)應(yīng)該能夠有效的項目規(guī)劃和管理。A 部分可用于預(yù)先審查，以便即時通知制造商顯爾易見的問題或某些具體方面沒有包括在設(shè)計開發(fā)資料中的問題PART B: Annexes B 部分 附件1. Essential Requirements Checklist 基本要求檢查表 Example: 例 :E.R. 基本要求applicability all ap

30、plied 是否適用standards (with date of issue) 標(biāo)準(zhǔn) ( 帶有效發(fā)布時 間)compliance demonstrated by(referenced documents) 證明材料 (參考文檔 )location section 所在章節(jié)7.1 (text) 內(nèi)容Yes 是/否ENISO10993-1:2003-5:1999等EN62336=IEC62336laboratory test reports:- cytotoxicity (report number and date) 實驗室測試報告 -細(xì)胞毒性 (報告 編號和日期 )Section a) b)

31、 c) 6.1節(jié)See also Attachment I: European Norms and Standards and other Documents supporting Technical Files and Design Dossiers.另見附件 I: 歐洲的規(guī)范和標(biāo)準(zhǔn)及配套技術(shù)文件和其他設(shè)計檔案材料2. Risk Analysis 風(fēng)險分析The document (Risk Management File) which describes the result of the risk management (including risk analysis, evaluati

32、on, mitigation and overall residual risk evaluation and production/post production information see ISO 14971 fig. B1 for an overview) process should contain at least the following information:風(fēng)險管理文檔描述了風(fēng)險管理的結(jié)果(包括風(fēng)險分析 ,風(fēng)險評估 ,風(fēng)險降低和剩余風(fēng)險評價以及按照 ISO 14971 fig. B1 進(jìn)行的生產(chǎn) /生產(chǎn)后信息評價 ),風(fēng)險分析程序到少包括下面 和信息 ;General

33、information 簡要信息o Summary 概要o Purpose of the document including project phase(s) / life cycle phase(s) for whichthe risk analysis was performed and reviewed Scope (e.g. design/product, manufacturing process, user/operation); product identification and description; intended use, shelf life.文件的目的包括項目階

34、段(第) /風(fēng)險分析進(jìn)行的生命周期階段( s)和審查范圍 (例:設(shè)計生產(chǎn)制造程序， 使用者操作 ) ；產(chǎn)品標(biāo)識和說明，用途，有效期。o Reference to: Risk Management SOP and Plan, Risk Management Policy, standards (EN ISO 14971, ISO 22442 part 1 -3 and MEDDEV 2.5-8 strongly recommended), specification documents, design documents, procedures, protocols, reports, manu

35、facturing and production process information 參考：風(fēng)險管理標(biāo)準(zhǔn)操作程序和計劃， 風(fēng)險管理政策， 標(biāo)準(zhǔn)(EN ISO 14971, ISO 22442 第 1 -3 和 MEDDEV 2.5-8 強制執(zhí)行)， 規(guī)范文件，設(shè)計文檔，規(guī)程，協(xié)議，報告，制造和生產(chǎn)過程的信息o Definition of terms, abbreviations and acronyms術(shù)語定義，縮略語o Participants of the risk analysis team (persons and organisations), their qualificati

36、on,responsibility and authority. 風(fēng)險分析團(tuán)隊(個人和組織)，他們的證書，職責(zé)和權(quán)力。o Note: the Risk Analysis shall include a medical knowledgeable and experiencedexpert in the corresponding field of application. 注：風(fēng)險分析應(yīng)有一個具有醫(yī)療知識和相關(guān)領(lǐng)域應(yīng)用經(jīng)驗的專家 o Note: The Risk Management Plan according to ISO 14971 -especially in relation tor

37、isk acceptance criteria- has to be defined by the top management under consideration of the estimated production volume to be sold per year and under consideration of regulatory requirements.注：風(fēng)險管理計劃根據(jù) ISO 14971 尤其是有關(guān)風(fēng)險接受準(zhǔn)則已被高層管理人員定義(考慮預(yù)計每年的 產(chǎn)量和銷售量以及監(jiān)管規(guī)定)o Identification of medical device characteri

38、stics that could impact on safety, e.g. according to ISO 14971.識別可能影響安全的醫(yī)療設(shè)備的特征，例：參照 ISO 14971o If applicable consideration of data obtained from literature review, usability testing, market surveillance of similar devices, post market surveillance or post market clinical follow-up (also related to

39、e.g. change notifications, predicate or otherwise comparable devices): complaint history, incidents per number of devices sold, analysis of underlying causes and final outcome, corrective and preventive action including proof of effectiveness 如果適用性審議的數(shù)據(jù)來自文獻(xiàn)回顧， 可用性測試， 市場類似產(chǎn)品對比， 產(chǎn)品售后信息和售后臨床隨訪 (其 他相關(guān)的如

40、：更改通知，其他方式類似裝置 )投訴歷史，事故占銷售設(shè)備的數(shù)量，分析事故原因及最終結(jié) 果，糾正和預(yù)防措施，包括有效的證明。o Revision history 修訂歷史Methodology 評估方法o Hazards / hazardous situations in normal condition : Hazard Analysis; patient/user related (top-down approach), e.g. Fault Tree Analysis, table format 在正常狀態(tài)下的危害 /危害性情況 ;危害分析 ;病人 /相關(guān)使用者 (自上而下方法 ),例如:

41、失效 的樹形分析 , 表格格式Clinical experience and clinical risks 臨床經(jīng)驗和臨床風(fēng)險Method for identification of applicable hazards; sources of information used 識別可適用性危害的方法 ;所用信息的來源Method for determination of the potential causes of hazards; sources of information used 判定危害的潛在原因的方法 ;所用信息的來源System used for categorization

42、 of severity levels (e.g. examples); descriptionof consequences to patients, users and other persons 嚴(yán)重程度的分類系統(tǒng) (例如:舉例);對病人 ,用戶和其它人產(chǎn)生的后果描述System used for categorization of occurrence of each hazard cause (probabilityestimate, frequency express ed as e.g. events per device and time)每種危害原因產(chǎn)生的分類系統(tǒng) (可能性估

43、計 ,頻率表述為 ”根據(jù)器械和次數(shù)的事件 ”)Method for combination of severity and occurrence to risk level (e.g. diagram,graph, formula) 風(fēng)險水平的嚴(yán)重和發(fā)生的組合方法 (例如:圖表 ,圖形 ,公式)Criteria for risk acceptance (e.g. acceptable, ALARP, unacceptable) underconsideration of the risk management plan and accumulated risks 考慮到風(fēng)險管理計劃和累計風(fēng)險情

44、況下的風(fēng)險可接受性標(biāo)準(zhǔn)(例如 :可接受 , 可操作又合理的最低情況 ,不可接受 )Note: If residual risks remain in ALARP region a rational should be ready tosubstantiate that no further mitigation was possible according to risk controloption analysis.注意 :如果剩余風(fēng)險是在 ”可操作又合理的最低情況 ”的范圍內(nèi) ,應(yīng)該根據(jù)風(fēng)險控制選擇分 析合理地證實沒有其它的緩解措施 .o Hazards / hazardous situa

45、tions in fault condition: e.g. FMEA; device related(bottom-up approach)在失效狀況下的危害 /危害性情況 :例如 : 潛在失效模式及后果分析 ;相關(guān)器械 ( 自下而上 方法)Method for identification of applicable failure modes; sources of informationUsed 適用的失效模式識別方法 ;所用信息來源Method for determination of the potential causes of failure modes; sources of

46、information used 失效模式的潛在原因的判定方法 ;所用信息來源System used for categorization of severity levels; description of consequencesto patients, users and other persons 嚴(yán)重程度分類系統(tǒng) ;對病人 ,用戶和其它人所產(chǎn)生的后果描述System used for categorization of occurrence of each failure mode (probabilityestimate, frequency expressed as e.g. e

47、vents per device and time)每種失效模式發(fā)生的分類系統(tǒng) (可能性估計 ,頻率表述為 ”根據(jù)器械和次數(shù)的事件 ”)System used for categorization of detectability of each failure mode (criteriafor detectability, frequency of in-process testing: 100%, sampling, or no testingi.e. validated process)每種失效模式的可檢測性分類系統(tǒng) (可檢測性標(biāo)準(zhǔn) , 進(jìn)程內(nèi)測試頻率 :100%, 抽樣 ,或者無 測

48、試 ,也就是經(jīng)驗證的過程 )Method for combination of severity, occurrence and detectability to risk level under consideration of the risk definition (see ISO 14971 2.16) (e.g. diagram, graph, formula）在考慮風(fēng)險定義 （參見ISO 14971 2.16）（例如:圖表,圖形,公式）情況下 , 風(fēng)險程度的嚴(yán)重 發(fā)生和可檢測的組合方法Criteria for risk acceptability （e.g. acceptable,

49、 ALARP, unacceptable） underconsideration of the risk management plan and under consideration of accumulated risks在考慮風(fēng)險管理計劃和累計風(fēng)險情況下 ,風(fēng)險可接受性的標(biāo)準(zhǔn) （例如:可接受 , 可操作又合 理的最低情況 ,不可接受 ）Note: If residual risks remain in ALARP region a rational should be ready tosubstantiate that no further mitigation was possible

50、 according to risk control option analysis.注意 :如果剩余風(fēng)險是在 ”可操作又合理的最低情況 ”的范圍內(nèi) ,應(yīng)該根據(jù)風(fēng)險控制選擇分 析合理地證實沒有其它的緩解措施 .Result （signed and dated documents）: Risk Management Report結(jié)果 （文件上有簽字和日期 ）:風(fēng)險管理報告o Hazards / hazardous situations in normal condition正常狀態(tài)下的危害 / 危害性狀況 : list of applicable hazards 列出適用危害 ;for each

51、 hazard （table format in hierarchical structure, if applicable）對于每一種危害 （層級結(jié)構(gòu)的表格形式 ,如果適用的話 ）List of potential worst case effects （description of consequences to patients,users and other persons 列出潛在的最壞情況的影響 （對病人 ,使用者和其他人所產(chǎn)生的 后果描述 ）List of potential causes of hazards as appropriate適當(dāng)列出危害的可能原因Estimatio

52、n of risk before mitigation （severity, occurrence, risk） including decisionon acceptability 緩解措施前的風(fēng)險評估 （嚴(yán)重 ,發(fā)生,危險 ）,包括可接受性的判定Definition of risk reduction measures including reference tomethods （e.g. design, testing, manufacturing） and results of verification （implementation and effectiveness） 風(fēng)險降低措施

53、的定義 ,包括方法（例如:設(shè)計,測試,制造）,確認(rèn)結(jié)果（實施和有效性 ）Estimation of risk after mitigation （severity, occurrence, risk） including decision on acceptability under consideration of the risk management plan and under consideration of accumulated risks 在考慮風(fēng)險管理計劃和累計風(fēng)險情況下 , 緩解措施后的風(fēng)險評估 (嚴(yán)重 ,發(fā)生 ,危險 ), 包 括可接受性的判定Risk / benefit

54、 weighting under consideration of the state of the art 在考慮工藝狀態(tài)情況下的風(fēng)險 /獲益權(quán)衡o Hazards / hazardous situations in fault condition : list of applicable failuremodes; for each failure mode (table format in hierarchical structure, if applicable):在失效情況下的危害 / 危害性情況 :列出適用的實失效模式 ; 對于每種失效模式 ( 層級結(jié)構(gòu) 的表格形式 , 如果適用的

55、話 ):List of potential failure modes 列出可能的失效模式List of potential worst case effects (description of consequences to patients,users and other) 列出潛在的最壞情況的影響對病人 , 使用者和其他人所產(chǎn)生的后果描 述)List of potential causes of failures (as appropriate)適當(dāng)列出危害的可能原因Estimation of risk before mitigation (severity, occurrence, d

56、etectability, risk) including decision on acceptability 緩解措施前的風(fēng)險評估 (嚴(yán)重,發(fā)生,可接受性 ,危險 ),包括可接受性的判定Definition of risk reduction measures including reference to methods (e.g. design,testing, manufacturing) and results of verification (implementation and effectiveness)風(fēng)險降低措施的定義 ,包括方法 (例如:設(shè)計 ,測試,制造)和驗證結(jié)果 (實

57、施和有效性 )Estimation of risk after mitigation (severity, occurrence, detectability, risk) includingdecision on acceptability緩解措施之后的風(fēng)險估計 (嚴(yán)重,發(fā)生,可檢測 ,危險),包括有關(guān)于可接受性的決定 .Risk / benefit weighting under consideration of the state of the art在考慮工藝水平情況下的風(fēng)險 /獲益權(quán)衡o New hazards: Assessment of risks associated with

58、 new hazards in normal andfault condition generated by risk mitigation measures. Corresponding risk reduction,if applicable新危害 :評估與在正常和失效狀態(tài)下由風(fēng)險緩解措施所產(chǎn)生的新危害有關(guān)聯(lián)的危害. 相應(yīng)的風(fēng)險降低 ,如果適用的話 .Final judgment, statement of 對以下內(nèi)容的最終判斷 ,陳述 :o Completeness of risk evaluation 風(fēng)險分析的完整性o Effectiveness of mitigation meas

59、ures including a link to the verification documents 緩解措施的有效性 ,包括連接到驗證文件o Overall acceptability of residual risk 剩余風(fēng)險的整體可接受性o Signed and dated by the team leader or responsible person團(tuán)隊領(lǐng)導(dǎo)或負(fù)責(zé)人簽字并署上日期3. Drawings, Design-, Product-Specifications圖紙 ,設(shè)計和產(chǎn)品規(guī)格Comprehensive description of the product產(chǎn)品的綜合描述C

60、omponents and materials: complete chemical, biological and physical characterization 部件和材料 :完整的化學(xué) ,生物和物理性特性描述Photographs, Blueprints 照片 ,圖紙F(tuán)unctional characteristics and technical performance specifications such as mechanical,physical, electrical, biological, chemical, sterility, stability, packagin