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

ISO-14155 - 2ND EDITION - CURRENT
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Included in this current edition are the following subparts:

 2ND EDITION - Feb. 1, 2011
 2ND EDITION CORRIGENDUM 1 - July 15, 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.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 14155:2011

Revision Level

2ND EDITION

Status

Current

Publication Date

Feb. 1, 2011

Committee Number

ISO/TC 194