醫(yī)療器械指令MDD基本要求檢查表

1、德信誠培訓(xùn)網(wǎng)93/42/EEC in cludi ng 2007/47/EC Annex IEsse ntial Requireme nts Checklist93/42/EEC 包括 2007/47/EC 基本要求檢查表Product n ame:產(chǎn)品名：Type(s)/Model(s):類型/型號Product group:產(chǎn)品族Issue date of Tech nicalFile:技術(shù)文檔發(fā)布日：Legal Man ufacturer:法定制造商N(yùn)ame 名字：Street 街道：Postal code 郵編Place 地點(diǎn)Country 國家Accessories附件：Date 日

2、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uuuuu;.55bo叫好好學(xué)3天天向上Revisi on of TechnicalFile:技術(shù)文檔修訂版本：德信誠培訓(xùn)網(wǎng)更多免費(fèi)資料下載請進(jìn)：http:/好好學(xué)習(xí)社區(qū)德信誠培訓(xùn)網(wǎng)更多免費(fèi)資料下載請進(jìn)：http:/好好學(xué)習(xí)社區(qū)uuuuuu55bopcon丨好好學(xué)習(xí)天天向上Checklist according to annex I of the Medical

3、 Device Directive (MDD)A/NA適用/ 不適用Standards, other directives and otherrules 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 noapplicability)支持性文件(測試報告，方案， 文獻(xiàn)或不適用的理由)Requirements fulfilled(tobe filled in by Notified Body)要求滿足(由公告機(jī)構(gòu)填寫)Ok /Fail符合

4、/不符合按醫(yī)療器械指令（MDD）附錄一的 基本要求檢查表I.Gen eral Requireme nts 通用要求1.The devices must be designed and manufactured in such a waythat, when used under the conditions and for the purposes intended,they will not compromise the clinical condition or the safety ofpatients, or the safety and health of users or, whe

5、re applicable,other persons, provided that any risks which may be associated withtheir intended use constitute acceptable risks when weighed againstthe benefits to the patient and are compatible with a high level ofprotection of health and safety.器械的生產(chǎn)和設(shè)計必須保證：按照其預(yù)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

6、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，與之給患者帶來的益處相比，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 theergonomic features of the device and the environment in whichthe device is intended to be used (design for patient safety), and*consideration of the technic

7、al knowledge, experience,education and training and where applicable the medical andphysical 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)計的)的錯誤使用而產(chǎn)生的風(fēng)P德信誠培訓(xùn)網(wǎng)更多免費(fèi)資料下載請進(jìn)：http:/好好學(xué)習(xí)社區(qū)uuuuuu55bopcon丨好好學(xué)習(xí)天天向上Checklist accordin

8、g 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 otherrules 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 noapplicability)支持性文件(測試報告，方案， 文獻(xiàn)或不適用的理由)Requirements fulfilled(tobe

9、 filled in by Notified Body)要求滿足(由公告機(jī)構(gòu)填寫)Ok /Fail符合/不符合險，和考慮技術(shù)知識、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。2.The solutions adopted by the manufacturer for the design andconstruction of the devices must conform to safety principles, takingaccount of the generally acknowledged state of the art.In

10、selecting the most appropriate solutions, the manufacturer mustapply the following principles in the following order:* eliminate or reduce risks as far as possible (inherently safedesign and construction), where appropriate take adequate protection measures includingalarms if necessary, in relation to risks that cannot be eliminated,(l) Inform users of the residual risks due to any shortcomings of theprotection