IS/ISO 14155 : 2020 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice
NATIONAL FOREWORD
This Indian Standard (First Revision) which is an identical adoption of ISO 14155 : 2020 'Clinical investigation of medical devices for human subjects - Good clinical practice' issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on the recommendation of In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.
This standard was first published as IS/ISO 14155 : 2011 'Clinical investigation of medical devices for human subjects - Good clinical practice'. This revision has been undertaken to align it with the latest edition of ISO 14155 : 2020.
The text of ISO standard may be approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:
a) Wherever the words 'International Standard' appear referring to this standard,they should be read as 'Indian Standard'; and
b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.