C 185 Official Journal
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ISSN 1725-2423 Official Journal C 185 of the European Union Volume 54 English edition Information and Notices 25 June 2011 Notice No Contents Page II Information INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES European Commission 2011/C 185/01 Explanatory Notes to the Combined Nomenclature of the European Union . 1 IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES European Commission 2011/C 185/02 Euro exchange rates . 2 2011/C 185/03 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 ( 1 ) (Publication of titles and references of harmonised standards under the directive) . 3 Price: 1 EN EUR 3 ( ) Text with EEA relevance (Continued overleaf) Notice No Contents (continued) Page V Announcements ADMINISTRATIVE PROCEDURES European Investment Bank 2011/C 185/04 Call for proposals — The European Investment Bank proposes three new EIBURS sponsorships within its EIB-Universities Research Action . 7 OTHER ACTS European Commission 2011/C 185/05 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs . 10 2011/C 185/06 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs . 14 2011/C 185/07 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs . 18 EN 25.6.2011 EN Official Journal of the European Union C 185/1 II (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Explanatory Notes to the Combined Nomenclature of the European Union (2011/C 185/01) Pursuant to Article 9(1)(a), second indent, of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( 1 ), the Explanatory Notes to the Combined Nomenclature of the European Union ( 2) are amended as from 1 July 2011 as follows: On page 342: the Explanatory Note for CN code 8521 90 00 is deleted. On page 347: the Explanatory Notes for CN codes 8528 71 13, 8528 71 19 and 8528 71 90 are deleted. ( 1 ) OJ L 256, 7.9.1987, p. 1. ( 2 ) OJ C 137, 6.5.2011, p. 1. C 185/2 EN Official Journal of the European Union 25.6.2011 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Euro exchange rates ( 1) 24 June 2011 (2011/C 185/02) 1 euro = Currency Exchange rate Currency Exchange rate USD US dollar 1,4220 AUD Australian dollar 1,3473 JPY Japanese yen 114,06 CAD Canadian dollar 1,3961 DKK Danish krone 7,4587 HKD Hong Kong dollar 11,0767 GBP Pound sterling 0,88855 NZD New Zealand dollar 1,7482 SEK Swedish krona 9,1802 SGD Singapore dollar 1,7597 KRW South Korean won 1 534,15 CHF Swiss franc 1,1902 ZAR South African rand 9,7683 ISK Iceland króna CNY Chinese yuan renminbi 9,2059 NOK Norwegian krone 7,7825 HRK Croatian kuna 7,3740 BGN Bulgarian lev 1,9558 IDR Indonesian rupiah 12 232,84 CZK Czech koruna 24,378 MYR Malaysian ringgit 4,3300 HUF Hungarian forint 269,50 PHP Philippine peso 61,765 LTL Lithuanian litas 3,4528 RUB Russian rouble 40,1300 LVL Latvian lats 0,7093 THB Thai baht 43,627 PLN Polish zloty 3,9919 BRL Brazilian real 2,2707 RON Romanian leu 4,2240 MXN Mexican peso 16,8867 TRY Turkish lira 2,3207 INR Indian rupee 63,9830 ( 1 ) Source: reference exchange rate published by the ECB. 25.6.2011 EN Official Journal of the European Union C 185/3 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 harmonised standards under the directive) (2011/C 185/03) Date of cessation of presumption of Reference and title of the harmonised standard Reference of superseded ESO ( 1 ) First publication OJ conformity of superseded (and reference document) standard standard Note 1 CEN EN 556-1:2001 31.7.2002 EN 556:1994 + A1:1998 Date expired Sterilization of medical devices - Requirements for medical Note 2.1 (30.4.2002) devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001/AC:2006 15.11.2006 CEN EN 556-2:2003 9.8.2007 Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 2: Requirements for aseptically processed medical devices CEN EN 980:2008 23.7.2008 EN 980:2003 Date expired Symbols for use in the labelling of medical devices Note 2.1 (31.5.2010) CEN EN ISO 11737-2:2009 7.7.2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) CEN EN 12322:1999 9.10.1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media EN 12322:1999/A1:2001 31.7.2002 Note 3 Date expired (30.4.2002) CEN EN ISO 13485:2003 2.4.2004 EN ISO 13488:2000 Date expired Medical devices - Quality management systems - Requirements EN ISO 13485:2000 (31.7.2009) for regulatory purposes (ISO 13485:2003) Note 2.1 EN ISO 13485:2003/AC:2009 7.7.2010 CEN EN 13532:2002 17.12.2002 General requirements for in vitro diagnostic medical devices for self-testing CEN EN 13612:2002 17.12.2002 Performance evaluation of in vitro diagnostic medical devices EN 13612:2002/AC:2002 2.12.2009 CEN EN 13640:2002 17.12.2002 Stability testing of in vitro diagnostic reagents CEN EN 13641:2002 17.12.2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents CEN EN 13975:2003 21.11.2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects C 185/4 EN Official Journal of the European Union 25.6.2011 Date of cessation of presumption of Reference and title of the harmonised standard Reference of superseded ESO ( 1 ) First publication OJ conformity of superseded (and reference document) standard standard Note 1 CEN EN 14136:2004 15.11.2006 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures CEN EN 14254:2004 28.4.2005 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans CEN EN 14820:2004 28.4.2005 Single-use containers for human venous blood specimen collection CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 Date expired Sterilization of health care products - General requirements for Note 2.1 (30.4.2010) characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) CEN EN ISO 14971:2009 7.7.2010 EN ISO 14971:2007 Date expired Medical devices - Application of risk management to medical Note 2.1 (21.3.2010) devices (ISO 14971:2007, Corrected version 2007-10-01) CEN EN ISO 15193:2009 7.7.2010 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) CEN EN ISO 15194:2009 7.7.2010 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documen tation (ISO 15194:2009) CEN EN ISO 15197:2003 28.4.2005 In vitro diagnostic test systems - Requirements for blood- glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) EN ISO 15197:2003/AC:2005 2.12.2009 CEN EN ISO 17511:2003 28.4.2005 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) CEN EN ISO 18113-1:2009 7.7.2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) CEN EN ISO 18113-2:2009 7.7.2010 EN 375:2001 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) CEN EN ISO 18113-3:2009 7.7.2010 EN 591:2001 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) 25.6.2011 EN Official Journal of the European Union C 185/5 Date of cessation of presumption of Reference and title of the harmonised standard Reference of superseded ESO ( 1 ) First publication OJ conformity of superseded (and reference document) standard standard Note 1 CEN EN ISO 18113-4:2009 7.7.2010 EN 376:2002 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) CEN EN ISO 18113-5:2009 7.7.2010 EN 592:2002 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer