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About This Item

 

Full Description

Defines procedures for the conduct and performance of clinical investigations of medical devices.
 

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


    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

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

    • Historical Version