Essential Requirements Checklist of the MDD(07 47 EC)基本要求检查表(中英文)
1、Esse ntial Requireme nts of the MDD (07/47/EC)Applicable(Y/N)适用(是/否)RequirementsStandard所符合的标准要求Manu facturersOk /Fail医疗器械指令(07/47/EC )Complia nce/Reco基本要求rds制造商符符合/合性文件/记录不符合I.GENERAL REQUIREME 基本要求ApplicableRequirementsManu facturersOk /Esse nt...
EssentialRequirementsofthe MDD(07/47/EC) 基本要求 医疗器械指令(07/47/EC) (Y/N)适用 (是/否) Standard所符合的标 准要求 Compliance/Reco rds制造商符 合性文件/记录 Fail 符合/ 不符合 1. Thedevicesmustbedesignedandmanufacturedinsuchawaythat,whenusedundertheconditionsandforthepurposesintended,theywill...
essentialrequirementschecklistofthemdd基本要求检查表(中英文).docx,Essential Requirements of the MDD (07/47/EC) 医疗器械指令(07/47/EC )基本要求 Applicable (Y/N)适用 (是/否) Requirements Standard所符合的标 准要求 Manufacturers Compliance/Records 制造商符合
"General requirements". Particular attention must be paid to: 医疗器械的设计和制造必须确保其符合“一般要求”中条款 1 所描述的特征和 性能。应特别注意: Essential Requirements Checklist of the MDD (07/47/EC) Essential Requirements of the MDD (07/47/EC) 医疗器械指令(07/47/EC)基本要求 Applicable...
Essential Requirements of the (Y/N) 适用 Standard 所符合的标 MDD (07/47/EC) (是 /否) 准要求 Fail Compliance/Reco 医疗器械指令( 07/47/EC ) 基本要求 rds 制造商符 符合 / 合性文件 / 记录 不符合 1. The devices must be designed and ...
[translate] a目标是跑3000米 goal was to go 3000m; [translate] a• Was an update of Essential Requirements checklist necessary • 是根本要求清单更新必要 [translate] 英语翻译 日语翻译 韩语翻译 德语翻译 法语翻译 俄语翻译 阿拉伯语翻译 西班牙语翻译 葡萄牙语翻译 意大利语翻译 荷兰语翻译 瑞典语翻译...
Essential Requirements Checklist of the MDD(07 47 EC)基本要求检查表(中英文) 热度: ivdd essential requirements checklist 热度: NEBS Requirements & Checklist Information 热度: 相关推荐 ESSENTIALREQUIREMENTSChecklistMDD93/42/EEC,AnnexI Device:___ No.EssentialRequirementsApplicable (yes/no) Standard/...
Therapeutic Goods Administration 摘要: Checklist for exporting medical devices from Australia to Europe showing Essential Requirements – Annex I, 93/42/EEC as amended by Directive 2007/47/EC DOI: http://www.tga.gov.au/industry/devices-forms-ecmra-ep-checklist. ...
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