DS/EN ISO 15197:2013
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Standard No.

DS/EN ISO 15197:2013

Release Date

2013

Published By

Danish Standards Foundation

Latest

DS/EN ISO 15197:2013

Replace

DS/EN ISO 15197:2003 DS/EN ISO 15197/AC:2005

Scope

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These sy

DS/EN ISO 15197:2013 history

• 2013 DS/EN ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
• 2011 DS/EN 16020:2011 Explosion diverters
• 0000 DS/EN ISO 15197/AC:2005
• 0000 DS/EN ISO 15197:2003