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Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic
medical devices
(Text with EEA relevance)
(Publication of titles and references of harmonid standards under the directive)
(2012/C 262/03)
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(1) ESO: European Standards Organisation:
— CEN: Avenue Marnix 17, 1000 Bruxelles/Brusl, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (u)
— Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brusl, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (lec.eu) — ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716, (si.eu)
祁同伟扮演者Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), t by the European Standardisation Organisation, but attention of urs of the
standards is drawn to the fact that in certain exceptional cas this can be otherwi.
Note 2.1: The new (or amended) standard has the same scope as the superded standard. On the date stated, the superded standard ceas to give presumption of conformity with the esntial
requirements of the directive.7字古诗
Note 2.2: The new standard has a broader scope than the superded standard. On the date stated the superded standard ceas to give presumption of conformity with the esntial requirements of
the directive.
Note 2.3: The new standard has a narrower scope than the superded standard. On the date stated the (partially) superded standard ceas to give presumption of conformity with the esntial
requirements of the directive for tho products that fall within the scope of the new
standard. Presumption of conformity with the esntial requirements of the directive for
products that still fall within the scope of the (partially) superded standard, but that do not
fall within the scope of the new standard, is unaffected.
Note 3: In ca of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superded standard therefore consists of EN
CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment.
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On the date stated, the superded standard ceas to give presumption of conformity with the
esntial requirements of the directive.
NOTE:
— Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to
the Directive 98/34/EC of the European Parliament and Council (1) amended by the Directive
98/48/EC (2).
— Harmonid standards are adopted by the European Standardisation Organisations in English (CEN and Cenelec also publish in French and German). Subquently, the titles of the harmonid standards are
translated into all other required official languages of the European Union by the National Standards
Bodies. The European Commission is not responsible for the correctness of the titles which have been
prented for publication in the Official Journal.
(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.
—
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.
— This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.
— More information about harmonid standards on the Internet at
ec.europa.eu/enterpri/policies/european-standards/harmonid-standards/i n dex_en.htm
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