DIN Standards Committee Health Technologies
DIN EN ISO 15197
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung bei Diabetes mellitus (ISO 15197:2013); Deutsche Fassung EN ISO 15197:2015
Document: references other documents
Responsible national committee
NA 176-08-06 AA - Point-of-Care-Testing (POCT)
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices