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About This Item
Full Description
The principles set forth in BS EN ISO 14155:2011 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.
BS EN 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 clinical investigation 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.
It does not apply to in vitro diagnostic medical devices.
NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of BS EN ISO 14155:2011 will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.
Cross References:
ISO 14971:2007
ISO 13485:2003
ISO 10993
ISO 15223-1
EN 1041
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 14155:2020
Clinical investigation of medical devices for human subjects. Good clinical practice- Most Recent
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BS EN ISO 14155:2011
viewing
Clinical investigation of medical devices for human subjects. Good clinical practice- Historical Version
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BS EN ISO 14155-1:2009
Clinical investigation of medical devices for human subjects-General requirements- Historical Version
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BS EN ISO 14155-2:2009
Clinical investigation of medical devices for human subjects-Clinical investigation plans- Historical Version
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BS 08/30116059 DC
BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice- Historical Version
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BS EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects-Clinical investigation plans- Historical Version
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BS EN ISO 14155-1:2003
Clinical investigation of medical devices for human subjects-General requirements- Historical Version
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BS EN 540:1993
Clinical investigation of medical devices for human subjects- Historical Version