BS ISO 11249:2018
Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies
standard by British Standard / International Organization for Standardization , 02/16/2018
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About This Item
Full Description
BS ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies.
It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.
Cross References:
ISO 15223
ISO 16142
ISO/TS 19218
EN 1041
ISO 13485
ISO 14155
ISO 10993
ISO 14971
ISO 15225
ISO 7439:2015 ED3
All current amendments available at time of purchase are included with the purchase of this document.
It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.
Cross References:
ISO 15223
ISO 16142
ISO/TS 19218
EN 1041
ISO 13485
ISO 14155
ISO 10993
ISO 14971
ISO 15225
ISO 7439:2015 ED3
All current amendments available at time of purchase are included with the purchase of this document.
