DIN Standards Committee Health Technologies
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Abstract
ISO 15197:2013 specifies 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. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
Begin
2024-12-20
WI
00140167
Planned document number
prEN ISO 15197 rev
Responsible national committee
NA 176-08-06 AA - Point-of-Care-Testing (POCT)
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
