EN ISO 15197:2003
In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003

Standard No.

EN ISO 15197:2003

Release Date

2003

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2013-05

Replace By

EN ISO 15197:2013

Latest

EN ISO 15197:2015

Scope

This International Standard specifies requirements for仍vitro glucose monitoring systems that measureglucose concentrations in capillary blood samples and procedures forThe verification andThe validation ofperformance byThe intended users. These systems are intended for self-testing by laypersons formanagement of diabetes mellitus.

EN ISO 15197:2003 history

• 2015 EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
• 2013 EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
• 2003 EN ISO 15197:2003 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197:2003