Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Design and development<br>5 Safety and reliability testing<br>6 Analytical performance evaluation<br>7 Information supplied by the manufacturer<br>8 User performance evaluation<br>Annex A (informative) - Possible interfering substances<br>Annex B (informative) - Traceability chain<br>Annex C (informative) - Rationale for the analytical<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;performance requirements<br>Annex ZA (informative) - Relationship between <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;this European Standard and the Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directive 98/79/EC <br>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	British Standards Institution
Pages
ISBN
Committee	CH/212
Supersedes	11/30208525 DC : 0 00/560160 DC : DRAFT JAN 2000