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About This Item

 

Full Description

Addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting.
 

Document History

  1. AAMI/ISO 14155:2020


    Clinical investigation of medical devices for human subjects - Good clinical practice

    • Most Recent
  2. AAMI/ISO 14155:2011

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    Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)

    • Historical Version
  3. AAMI/ISO 14155-2:2003/(R)2008


    Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

    • Historical Version
  4. AAMI/ISO 14155-1:2003/(R)2008


    Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 14155:2011 Errata

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    Erratum for Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)