Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
5 Safety and reliability testing
6 Analytical performance evaluation
7 Information supplied by the manufacturer
8 User performance evaluation
Annex A (informative) - Possible interfering substances
Annex B (informative) - Traceability chain
Annex C (informative) - Rationale for the analytical
        performance requirements
Bibliography

Abstract

Describes requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 212
Supersedes	ISO/DIS 15197 : 60.00 (2013)