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BS EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects-Clinical investigation plans

standard by British Standard / European Standard / International Organization for Standardization , 01/31/2010

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About This Item

 

Full Description

BS EN ISO 14155-2:2009 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.

BS EN ISO 14155-2:2009 does not apply to in vitro diagnostic medical devices.



Cross References:
EN ISO 14155-1:2003
ISO 14155-1:2001
EN ISO 14971
EN ISO 10993
93/42/EEC
90/385/EEC


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
01/31/2010
ISBN(s):
9780580690112
Number of Pages:
20
File Size:
1 file , 810 KB
Product Code(s):
30209183, 30209183, 30209183
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 14155:2020


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

    • Most Recent

  2. BS EN ISO 14155:2011


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

    • Historical Version

  3. BS EN ISO 14155-1:2009


    Clinical investigation of medical devices for human subjects-General requirements

    • Historical Version

  4. BS EN ISO 14155-2:2009

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    viewing


    Clinical investigation of medical devices for human subjects-Clinical investigation plans

    • Historical Version

  5. BS 08/30116059 DC


    BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

    • Historical Version

  6. BS EN ISO 14155-2:2003


    Clinical investigation of medical devices for human subjects-Clinical investigation plans

    • Historical Version

  7. BS EN ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects-General requirements

    • Historical Version

  8. BS EN 540:1993


    Clinical investigation of medical devices for human subjects

    • Historical Version