無源醫療器械的指導技術文檔和設計文檔編寫指南（25頁）

• 資料介紹

  醫療器械技術文檔編寫指南（25頁）

  PART A: Technical Documentation / Design Dossier
  1.Table of Content
  2.Introduction
  3.Design Dossier/Technical Documentation Summary Information
  PART B: Annexes
  1.Essential Requirements Checklist
  2.Risk Analysis
  3.Drawings, Design -, Product - Specifications
  4.Chemical, Physical and Biological Tests
  4.1 In Vitro Testing - Preclinical Studies
  4.2 In Vivo Testing - Preclinical Studies
  4.3 Biocompatibility Tests
  4.4 Bio-stability Tests
  4.5 Microbiological Safety, Animal Origin Tissue
  4.6 Drug / medical device combination
  4.7 Blood Derivates, Human Tissue / medical device combination
  4.8 Coated Medical Devices
  5.Clinical Data
  6.Labels and Instructions for Use
  7.Manufacturing
  8.Package Qualification and Shelf life
  9.Sterilization
  10.Measuring Function
  11.Combination with other Medical Devices
  12.Compatibility to drugs
  13.Other applicable directives and regulations
  14.Conclusion
  15.Declaration of Conformity (Draft)

• 資料大小：
  390.37KB
• 所屬類別：
  法規標準
• 更新日期：
  2020-03-22
• 適用行業：
  醫療器械
• 上傳人：
  Specth550
• 標 簽：

  CE MDD TF

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