Document Center now has the new ISO 14155:2011 Edition available for purchase. The standard, titled Clinical investigation of medical devices for human subjects — Good clinical practice, withdraws and replaces both the ISO-14155-1 and the ISO-14155-2.
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.
This new edition, as well as all the ISO standards, is available from Document Center Inc. at our website www.document-center.com. You can also contact us by phone at 650-591-7600, fax at 650-591-7617 or by email at info@document-center.com. We’re always happy to help you with any standards needs you may have.