Corrigendum to Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation) (Official Journal of the European Union C 173 of 13 May 2016) 2016/C 249/05
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Address https://gelex.eu/eli/EU/corrigendum/oj/C/2016/249/05@2016-07-08/en
Contents
On page 139, standard EN ISO 15197:2015: for: CEN 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) This is the first publication EN ISO 15197:2013 Note 2.1 30.6.2017 For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017., read: CEN EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing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) 13.5.2016 EN ISO 15197:2003 Note 2.1 31.7.2016 For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.;
on page 140, standard EN ISO 23640:2015: for: CEN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) This is the first publication EN ISO 23640:2013 Note 2.1 30.6.2017, read: CEN EN ISO 23640:2015 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) 13.5.2016 EN ISO 13640:2002 Note 2.1 30.6.2017.