BS EN 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 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. | File Size : | 1
file
, 1.5 MB |
| ISBN(s) : | 9780580760075, 9780580544736 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 70 |
| Product Code(s) : | 30249829, 30249829 |
| Published : | 09/30/2011 |
| Same As : | BS EN ISO 14155:2011 |
