中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

無源醫(yī)療器械的指導(dǎo)技術(shù)文檔和設(shè)計(jì)文檔編寫指南（25頁）

• 資料介紹

  醫(yī)療器械技術(shù)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?。?/label>
  390.37KB
• 所屬類別：
  法規(guī)標(biāo)準(zhǔn)
• 更新日期：
  2020-03-22
• 適用行業(yè)：
  醫(yī)療器械
• 上傳人：
  Specth550
• 標(biāo) 簽：

  CE MDD TF

  下載資料 上傳資料