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EN ISO 15197:2015/prA11

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

General information

10.99 New project approved   Feb 21, 2024

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

Related legislation

Legislation related to this standard

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15197:2015

NOW

IN_DEVELOPMENT
EN ISO 15197:2015/prA11
10.99 New project approved
Feb 21, 2024

REVISED BY

IN_DEVELOPMENT
prEN ISO 15197 rev