IVDD技術文件內容
Contents of TechnicalDocumentation
技術文件內容
Acc. to Annex I & III of IVDD98/79/EC按體外診斷醫(yī)療器械指令附錄III
Contents | 內容 | |
1. | Table of content | 目錄 |
2. 2.1 2.2 2.3 2.4 2.5 | General Information Manufacturer European Representative Short general description of the product Location of – design, -manufacturing facilities In case of contract design / manufacturing/sterilization | 一般信息 廠商 歐洲代表 產(chǎn)品的簡短描述 設計、生產(chǎn)場地 設計/生產(chǎn)/消毒的分承包方
|
3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9
| Product description Product family description Accessories Intended use Categorization Conformity assessment route Notified body Applicable standards Declaration of conformity Quality system certificate, approvals etc. | 產(chǎn)品描述 產(chǎn)品組描述 附件 預期用途 分類 符合性評審路徑 公告機構 適用的標準 符合性聲明 質量體系證書，批準等等 |
4 4.1 4.2 4.3 4.4
| 4.1 Product 4.2 Compliance with essential requirements 4.3 Risk Analysis Manufacturing Process Packaging specifications
| 產(chǎn)品 符合基本需求 風險分析 生產(chǎn)過程 包裝規(guī)格 |
5 5.1 5.2 5.3 5.4 5.5 5.6 5.7
| PRODUCT VERIFICATION Stability studies Performance evaluation studies For self testing devices Reference material, calibration and control materials Safety testing Software validation QC / QA processes
| 產(chǎn)品確認 穩(wěn)定性研究 性能評估研究 自我測試器械 參考材料，校準和對照材料 安全測試 軟件驗證 QC/QA 過程 |
6 6.1 6.2 | LABELING AND INSTRUCTION FOR USE Labels Instruction for use | 標簽和使用說明書 標簽 使用說明書 |
7 | LITERATURE, PUBLICATIONS
| 文獻，出版物 |
5.1 8 | REVISION HISTORY OF THE TECHNICAL FILE
| 技術文件的修訂記錄 |