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英文字典中文字典相关资料:


  • ISO 14155:2020 (en), Clinical investigation of medical devices for . . .
    The procedures used to develop this document and those intended for its further maintenance are described in the ISO IEC Directives, Part 1 In particular the different approval criteria needed for the different types of ISO documents should be noted
  • ISO 14155:2026 (en), Clinical investigation of medical devices for . . .
    The procedures used to develop this document and those intended for its further maintenance are described in the ISO IEC Directives, Part 1 In particular, the different approval criteria needed for the different types of ISO document should be noted
  • INTERNATIONAL ISO STANDARD 14155
    If national or regional EC requirements are less strict than the requirements of this International Standard, the sponsor shall apply the requirements of this International Standard to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts
  • ISO 14155:2020 - ISO 14155:2020 - iTeh Standards
    International devel ped by ISO TC 194 are intended to be applied to medical devices
  • INTERNATIONAL ISO STANDARD 14155 - NormSplash
    Note 1 to entry: For the purpose of this document, “data and safety monitoring board (DSMB)”, “data and safety monitoring committee (DSMC)" or "independent data monitoring committee (IDMC)” are synonymous with DMC
  • EN ISO 14155:2020 - mdr-ce. com
    EN ISO 14155:2020 This European Standard was approved by CEN on 2 May 2020 CEN members are bound to comply with the CEN CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration
  • ISO 14155:2020 - 32352161. s21i. faiusr. com
    The permission obtained, data shall be permission to performance, follow-up effectiveness or The collection of follow-up data collect investigation from discontinued subjects can be subject to national regulations
  • ISO 14155:2020 - Clinical investigation of medical devices for human . . .
    This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices
  • ISO 14155
    For clinical investigations involving emergency treatments, when prior informed consent of the subject is not possible because of the subject's medical condition, the informed consent of the subject's legally authorized representative, if present, shall be requested
  • ISO 14155:2020 - REDLINE ISO 14155:2020 - cdn. standards. iteh. ai
    International devel ped by ISO TC 194 are intended to be applied to medical devices





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