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About This Item

 

Full Description

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimizing the scientific validity and reproducibility of the results of a clinical investigation.

This Standard does not apply to in vitro diagnostic 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

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    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