IS 18298 : 2023/ISO 17593 : 2022 Clinical Laboratory Testing and In-vitro Medical Devices - Requirements for In-vitro Monitoring Systems for Self-Testing of Oral Anticoagulant Therapy
NATIONAL FOREWORD
This Indian Standard (First Revision) which is identical with ISO 17593 : 2022 'Clinical laboratory testing and in-vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Medical Laboratory Instruments
Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. This standard was first published in 2021 as IS/ISO 17593 : 2007 which was an identical adoption of ISO 17593 : 2007 'Clinical laboratory testing and In-vitro medical devices - Requirements for In-vitro monitoring systems for self-testing of oral anticoagulant therapy'. This revision has been undertaken to align with the latest version of ISO 17593.
The text of ISO standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions are, however, not identical to those used in 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.