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Addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. It 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; and assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Author | ANSI/AAMI/ISO |
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Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2010-12-30 |
ICS | 11.100.20 : Biological evaluation of medical devices |
Replace | ANSI/AAMI/ISO 14155 (1996) |
Cross references | ISO 14155 (2011-02), IDT |
Year | 2010 |
Document history | ANSI/AAMI/ISO 14155 (2010) |
Country | USA |
Keyword | ANSI 14155;14155;ANSI/AAMI/ISO 14155-2010 |