ISO 14155-2:2003 Historical

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Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

standard by International Organization for Standardization , 05/15/2003

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Full Description

1 Scope

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 optimising the scientific validity and reproducibility of the results of a clinical investigation.

This Standard does not apply to in vitro diagnostic medical devices.

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Document History

  1. ISO 14155:2020 Plus Redline


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

    • Historical Version

  2. ISO 14155:2020


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

    • Most Recent

  3. ISO 14155:2011


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

    • Historical Version

  4. ISO 14155-2:2003

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    Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

    • Historical Version

  5. ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects - Part 1: General requirements

    • Historical Version

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Product Details

Published:

05/15/2003

Number of Pages:

9

File Size:

1 file

Same As:

DIN EN ISO 14155-2

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus