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NS-EN ISO 14155:2011

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

standard by Standards Norway NS-EN ISO , 05/01/2011

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Full Description

ADOPTED_FROM:EN ISO 14155:2011 ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
 

Product Details

Published:
05/01/2011
Number of Pages:
76
File Size:
1 file , 1.2 MB
Product Code(s):
1d9e60bf-8816-44e9-a594-32dddc743761, c1699f79-11bd-4f97-ad95-f2114c6769bd, 1d9e60bf-8816-44e9-a594-32dddc743761, c1699f79-11bd-4f97-ad95-f2114c6769bd, 1d9e60bf-8816-44e9-a594-32dddc743761, c1699f79-11bd-4f97-ad95-f2114c6769bd
 

Document History

  1. NS-EN ISO 14155:2011

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    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    • Most Recent

  2. NS-EN ISO 14155-1:2009


    Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

    • Historical Version

  3. NS-EN ISO 14155-2:2009


    Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

    • Historical Version

  4. NS-EN ISO 14155-1:2003


    Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)

    • Historical Version

  5. NS-EN ISO 14155-2:2003


    Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)

    • Historical Version

  6. NS-EN 540:1993


    Clinical investigation of medical devices for human subjects

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. NS-EN ISO 14155:2011/AC:2011

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    Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)