Reaffirmed 2020

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 15197 : 2013 ‘In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Surgical Dressings and Disposable Products Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was originally published in 2003. The first revision of this standard has been undertaken with a view to bring in line with the latest version of ISO 15197 : 2013.

Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetes mellitus is caused by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentrations of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood.

This standard is intended for blood-glucose monitoring systems used by lay persons. The primary objectives are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance to this standard.

This revision includes stricter criteria for accuracy. It adopts new analytical performance requirements for glucose meters intended for lay persons. The criteria now apply to the User Performance Evaluation in 8, a design validation activity that includes the added variability introduced by user technique. In the previous Indian Standard the system accuracy criteria only applies to the Analytical Performance Evaluation, which evaluated the analytical capability of the meter and system under controlled conditions.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies 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’.

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.