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Norm

ÖNORM EN ISO 14155

Issue date: 2011 05 15

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

This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to...
Withdrawn: 2012 02 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 67 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This International Standard 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 this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard specifies general requirements intended to protect the rights, safety and well-being of human subjects; to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results; to define the responsibilities of the sponsor and principal investigator, and to assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It does not apply to in vitro diagnostic medical devices.
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ISO 14971:2007
Issue date : 2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
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Issue date : 2012 02 15
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