# C_2016249EN.01020601.xml

| 8.7.2016 | EN | Official Journal of the European Union | C 249/206 |
| --- | --- | --- | --- |

8.7.2016

EN

Official Journal of the European Union

C 249/206

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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
  )

Official Journal of the European Union C 173 of 13 May 2016

(2016/C 249/05)

On page 139, standard EN ISO 15197:2015:

for:

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| For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.’, |

‘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For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.’,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:

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| For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.’; |

‘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For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.’;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:

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’, |
| --- | --- | --- | --- | --- |

‘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:

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’. |
| --- | --- | --- | --- | --- |

‘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’.

---