无源医疗器械的指导技术文档和设计文档编写指南（25页）

• 资料介绍

  医疗器械技术文档编写指南（25页）

  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)

• 资料大小：
  390.37KB
• 所属类别：
  法规标准
• 更新日期：
  2020-03-22
• 适用行业：
  医疗器械
• 上传人：
  Specth550
• 标 签：

  CE MDD TF

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