IS 18376 : 2023/ISO/TR 20416 : 2020 Medical Devices - Post-Market Surveillance for Manufacturers
NATIONAL FOREWORD
The Indian Standard which is identical with adoption of IS/ISO/TR 20416 : 2020 'Medical devices - Postmarket surveillance for manufacturers' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.
The text of the ISO standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are however not identical to those used in Indian Standards. Attention is particularly drawn to the following:
a) Wherever the words 'International Standard' appears referring to this standard, they should be read as 'Indian Standard'; and
b) Comma (,) has been used as a decimal marker while in Indian Standard, the current practice is to use a point (.) as the decimal marker.
In reporting the result of a test or analysis made in accordance with this standard, is to be rounded off, its shall be done in accordance with IS 2 : 2022 'Rules for rounding off numerical values (second revision)'