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Document 52016XC0513(09)R(01)
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) (OJ C 173, 13.5.2016)
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) (OJ C 173, 13.5.2016)
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) (OJ C 173, 13.5.2016)
IO C 249, 8.7.2016, p. 206–206
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
- Date of document:
- 08/07/2016; Dáta foilsithe
- Author:
- An Coimisiún Eorpach
- Form:
- Ceartúchán Fógraí
- Link
- Link
- Link
- Select all documents mentioning this document
- Earlier related instruments:
-
- Corrigendum to 52016XC0513(09)
- Link
- EUROVOC descriptor:
|
8.7.2016 |
EN |
Official Journal of the European Union |
C 249/206 |
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)
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For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.’, |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’. |
