# Official Journal C 41/2009

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 41 |
| | |
| English edition | Information and Notices | Volume 5219 February 2009 |

ISSN 1725-2423

Official Journal

of the European Union

C 41

English edition

Information and Notices

Volume 5219 February 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Resolutions, recommendations and opinions |
| | OPINIONS |
| | Commission |
| 2009/C 041/01 | Notice regarding the adaptation in line with inflation of certain amounts laid down in the Life and Non-Life Insurance Directives | 1 |

Notice No

Contents

page

I   Resolutions, recommendations and opinions

OPINIONS

Commission

2009/C 041/01

Notice regarding the adaptation in line with inflation of certain amounts laid down in the Life and Non-Life Insurance Directives

1

| | II   Information |
| --- | --- |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 041/02 | Communication from the Commission concerning Council Regulation (Euratom) No 1493/93 on shipments of radioactive substances between Member States | 2 |

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 041/02

Communication from the Commission concerning Council Regulation (Euratom) No 1493/93 on shipments of radioactive substances between Member States

2

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 041/03 | Euro exchange rates | 7 |
| 2009/C 041/04 | Adoption of a reference document for the purpose of Council Directive 2008/1/EC concerning integrated pollution prevention and control | 8 |
| | NOTICES FROM MEMBER STATES |
| 2009/C 041/05 | Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (
  1
  ) | 9 |
| 2009/C 041/06 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (
  1
  ) | 13 |
| 2009/C 041/07 | Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (
  1
  ) | 27 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 041/03

Euro exchange rates

7

2009/C 041/04

Adoption of a reference document for the purpose of Council Directive 2008/1/EC concerning integrated pollution prevention and control

8

NOTICES FROM MEMBER STATES

2009/C 041/05

Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (
  1
  )

1

9

2009/C 041/06

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (
  1
  )

1

13

2009/C 041/07

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (
  1
  )

in vitro

1

27

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2009/C 041/08 | Call for proposals under the annual work programme for grants in the field of the Trans-European Energy Network (TEN-E) for 2009 (Commission Decision C(2009) 1360) | 30 |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2009/C 041/09 | Action brought on 3 February 2009 by the EFTA Surveillance Authority against the Principality of Liechtenstein (Case E-1/09) | 31 |
| 2009/C 041/10 | Action brought on 6 February 2009 by the EFTA Surveillance Authority against Iceland (Case E-2/09) | 32 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 041/11 | Prior notification of a concentration (Case COMP/M.5456 — AIP/BBEIF/BBI Europe/Euroports) — Candidate case for simplified procedure (
  1
  ) | 33 |
| 2009/C 041/12 | Prior notification of a concentration (Case COMP/M.5427 — Dexia Crédit Local/Dexia Kommunalkredit Bank) — Candidate case for simplified procedure (
  1
  ) | 34 |
| | OTHER ACTS |
| | Commission |
| 2009/C 041/13 | 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 | 35 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2009/C 041/08

Call for proposals under the annual work programme for grants in the field of the Trans-European Energy Network (TEN-E) for 2009 (Commission Decision C(2009) 1360)

30

COURT PROCEEDINGS

EFTA Court

2009/C 041/09

Action brought on 3 February 2009 by the EFTA Surveillance Authority against the Principality of Liechtenstein (Case E-1/09)

31

2009/C 041/10

Action brought on 6 February 2009 by the EFTA Surveillance Authority against Iceland (Case E-2/09)

32

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 041/11

Prior notification of a concentration (Case COMP/M.5456 — AIP/BBEIF/BBI Europe/Euroports) — Candidate case for simplified procedure (
  1
  )

1

33

2009/C 041/12

Prior notification of a concentration (Case COMP/M.5427 — Dexia Crédit Local/Dexia Kommunalkredit Bank) — Candidate case for simplified procedure (
  1
  )

1

34

OTHER ACTS

Commission

2009/C 041/13

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

35

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

---

I Resolutions, recommendations and opinions

OPINIONS

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/1 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/1

---

Notice regarding the adaptation in line with inflation of certain amounts laid down in the Life and Non-Life Insurance Directives

(2009/C 41/01)

In accordance with Article 30 of Directive 2002/83/EC (1) concerning life assurance, the amount laid down in euro in Article 29(2) was reviewed in 2008 in order to take account of changes in the European index of consumer prices comprising all Member States as published by Eurostat. As a result of the review, the amount laid down in euro is increased from EUR 3 200 000 to EUR 3 500 000. The Commission Services have informed the European Parliament and the Council of the review and the adapted amount.

In accordance with Article 17a of Directive 73/239/EEC (2) on the coordination of the laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance, as amended by Directive 2002/13/EC (3), the amounts laid down in euro in Article 16a(3) and (4) and Article 17(2) were reviewed in 2008 in order to take account of changes in the European index of consumer prices comprising all Member States as published by Eurostat. As a result of the review, the amount laid down in euro in Article 16a(3) is increased from EUR 53 100 000 to EUR 57 500 000. The amount laid down in euro in Article 16a(4) is increased from EUR 37 200 000 to EUR 40 300 000. The amounts laid down in euro in Article 17(2) are increased from EUR 2 200 000 to EUR 2 300 000 and from EUR 3 200 000 to EUR 3 500 000 respectively. The Commission Services have informed the European Parliament and the Council of the review and the adapted amounts.

---

(1)  OJ L 345, 19.12.2002, p. 1.

(2)  OJ L 228, 16.8.1973, p. 3.

(3)  OJ L 77, 20.3.2002, p. 17.

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/2 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/2

---

Communication from the Commission concerning Council Regulation (Euratom) No 1493/93 (1) on shipments of radioactive substances between Member States

(2009/C 41/02)

Pursuant to Article 8 of Regulation (Euratom) No 1493/93, the Member States are required to forward to the Commission the name(s) and the address(es) of the competent authorities as defined in Article 2 and all necessary information for rapidly communicating with such authorities.

Member States are required to notify the Commission of any changes to such data.

The Commission is required to communicate this information and any changes to it, to all competent authorities in the Community and publish it in the Official Journal of the European Union.

The present Communication from the Commission replaces Commission Communication 2002/C 40/04 concerning Council Regulation (Euratom) No 1493/93 on shipments of radioactive substances between Member States (OJ C 40, 14.2.2002, p. 4).

A list of competent authorities in the Member States and all necessary information for communicating rapidly with them are given below.

Competent authorities referred to in Regulation (Euratom) No 1493/93 on shipments of radioactive substances between Member States

BELGIQUE/BELGIË

| Agence fédérale de contrôle nucléaire (AFCN)/Federaal Agentschap voor Nucleaire Controle (FANC) |
| --- |
| Rue Ravenstein, 36 |
| B-1000 Bruxelles/Brussel |
| Tel.: (0032) 2 289 21 81 |
| Fax (0032) 2 289 21 82 |
| E-mail: Erik.Cottens@fanc.fgov.be |

Agence fédérale de contrôle nucléaire (AFCN)/Federaal Agentschap voor Nucleaire Controle (FANC)

Rue Ravenstein, 36

B-1000 Bruxelles/Brussel

Tel.: (0032) 2 289 21 81

Fax (0032) 2 289 21 82

E-mail: Erik.Cottens@fanc.fgov.be

БЪЛГАРИЯ

| Nuclear Regulatory Agency |
| --- |
| Contact person: Mr Sergey Tsochev |
| Shipchensky Prokhod Blvd., 69 |
| BG-1574 Sofia |
| Tel.: (359) 2 940 6801 |
| Fax (359) 2 940 06 919/(359) 2 870 21 43 |
| E-mail: s.tzotchev@bnra.bg |

Nuclear Regulatory Agency

Contact person: Mr Sergey Tsochev

Shipchensky Prokhod Blvd., 69

BG-1574 Sofia

Tel.: (359) 2 940 6801

Fax (359) 2 940 06 919/(359) 2 870 21 43

E-mail: s.tzotchev@bnra.bg

ČESKÁ REPUBLIKA

| Státní úřad pro jadernou bezpečnost |
| --- |
| Senovážné náměstí 9 |
| CZ-110 00 Praha 1 |
| Tel.: (00420) 221 624 666 |
| Fax (00420) 221 624 786 |
| E-mail: peter.lietava@sujb.cz |

Státní úřad pro jadernou bezpečnost

Senovážné náměstí 9

CZ-110 00 Praha 1

Tel.: (00420) 221 624 666

Fax (00420) 221 624 786

E-mail: peter.lietava@sujb.cz

DANMARK

| Statens Institut for Strålebeskyttelse |
| --- |
| Knapholm 7 |
| DK-2730 Herlev |
| Tel.: (0045) 44 54 34 54 |
| Fax (0045) 72 22 74 17 |
| E-mail: sis@sis.dk |
| Site web: www.sis.dk |

Statens Institut for Strålebeskyttelse

Knapholm 7

DK-2730 Herlev

Tel.: (0045) 44 54 34 54

Fax (0045) 72 22 74 17

E-mail: sis@sis.dk

Site web: www.sis.dk

DEUTSCHLAND

| Bundesamt für Wirtschaft und Ausfuhrkontrolle (BAFA) |
| --- |
| Frankfurter Straße 29-35 |
| D-65760 Eschborn |
| Tel.: (49) 6196 908 0 |
| Fax (49) 6196 908-859 |
| E-mail: poc.rad.sources@bafa.bund.de |

Bundesamt für Wirtschaft und Ausfuhrkontrolle (BAFA)

Frankfurter Straße 29-35

D-65760 Eschborn

Tel.: (49) 6196 908 0

Fax (49) 6196 908-859

E-mail: poc.rad.sources@bafa.bund.de

EESTI

| Ministry of the Environment |
| --- |
| Narva Street 7a |
| EE-15172 Tallinn (Estonia) |
| Air and Radiation Safety Bureau |
| Contact person: Ms Evelyn Pesur |
| Tel.: (+372) 62 62 982 |
| Fax (+372) 62 62 801 |
| E-mail: keskkonnaministeerium@envir.ee/evelyn.pesur@envir.ee |
| http://www.envir.ee/ |

Ministry of the Environment

Narva Street 7a

EE-15172 Tallinn (Estonia)

Air and Radiation Safety Bureau

Contact person: Ms Evelyn Pesur

Tel.: (+372) 62 62 982

Fax (+372) 62 62 801

E-mail: keskkonnaministeerium@envir.ee/evelyn.pesur@envir.ee

http://www.envir.ee/

IRLAND

| The Radiological Protection Institute of Ireland |
| --- |
| Contact person: Dr Tom Ryan |
| Director of Regulatory Services |
| Clonskeagh Square |
| Clonskeagh Road |
| Dublin 14 |
| Ireland |
| Tel.: (00 353) 1 269 77 66 |
| Fax (00 353) 1 269 74 37 |
| E-mail: tryan@rpii.ie |

The Radiological Protection Institute of Ireland

Contact person: Dr Tom Ryan

Director of Regulatory Services

Clonskeagh Square

Clonskeagh Road

Dublin 14

Ireland

Tel.: (00 353) 1 269 77 66

Fax (00 353) 1 269 74 37

E-mail: tryan@rpii.ie

ΕΛΛΑΔΑ

| Γραφείο Προέδρου/President's Office |
| --- |
| Ελληνική Επιτροπή Ατομικής Ενεργείας (EEAE)/Greek Atomic Energy Commission (GAEC) |
| Αγία Παρασκευή/Ag. Paraskevi |
| GR-15310 Αττικής/Attica |
| Τel.: (0030) 210 6506803 |
| Fax (0030) 210 6506762 |
| E-mail: thzorbak@eeae.gr |

Γραφείο Προέδρου/President's Office

Ελληνική Επιτροπή Ατομικής Ενεργείας (EEAE)/Greek Atomic Energy Commission (GAEC)

Αγία Παρασκευή/Ag. Paraskevi

GR-15310 Αττικής/Attica

Τel.: (0030) 210 6506803

Fax (0030) 210 6506762

E-mail: thzorbak@eeae.gr

ESPAÑA

| Comunidad Autónoma de las Islas Baleares |
| --- |
| Consejería de Comercio, Industria y Energía |
| Dirección General de Energía |
| Camí de Son Rapinya, 12 |
| E-07013 Palma de Mallorca |
| Tel.: (0034) 971 78 41 32 |
| Fax (0034) 971 17 74 95 |
| E-mail: rpons@energia.caib.es |

Comunidad Autónoma de las Islas Baleares

Consejería de Comercio, Industria y Energía

Dirección General de Energía

Camí de Son Rapinya, 12

E-07013 Palma de Mallorca

Tel.: (0034) 971 78 41 32

Fax (0034) 971 17 74 95

E-mail: rpons@energia.caib.es

| Comunidad Autónoma de Canarias |
| --- |
| Consejería de Industria, Comercio y Nuevas Tecnologías |
| Dirección General de Industria y Energía |
| c/ Cebrián 3 |
| E-35003 Las Palmas de Gran Canaria |
| Tel.: (0034) 928 45 20 00 |
| Fax (0034) 922 47 53 54 |
| E-mail: jcambet@gobiernodecanarias.org |

Comunidad Autónoma de Canarias

Consejería de Industria, Comercio y Nuevas Tecnologías

Dirección General de Industria y Energía

c/ Cebrián 3

E-35003 Las Palmas de Gran Canaria

Tel.: (0034) 928 45 20 00

Fax (0034) 922 47 53 54

E-mail: jcambet@gobiernodecanarias.org

| Comunidad Autónoma de Cantabria |
| --- |
| Consejería de Industria, Trabajo y Desarrollo Tecnológico |
| Dirección General de Industria |
| Paseo de Pereda, 31 — 1o drcha. |
| E-39004 Santander |
| Tel.: (0034) 942 31 89 20 |
| Fax (0034) 942 36 15 80 |
| E-mail: Rodríguez_m@gobcantabria.es |

Comunidad Autónoma de Cantabria

Consejería de Industria, Trabajo y Desarrollo Tecnológico

Dirección General de Industria

Paseo de Pereda, 31 — 1o drcha.

E-39004 Santander

Tel.: (0034) 942 31 89 20

Fax (0034) 942 36 15 80

E-mail: Rodríguez_m@gobcantabria.es

| Comunidad Autónoma de Castilla y León |
| --- |
| Consejería de Economía y Empleo |
| Dirección General de Industria e Innovación Tecnológica |
| c/ José Cantalapiedra, s/n |
| E-47014 Valladolid |
| Tel.: (0034) 983 41 40 00 |
| Fax (0034) 983 41 40 40 |
| E-mail: delfín.prieto@cict.jcyl.es |

Comunidad Autónoma de Castilla y León

Consejería de Economía y Empleo

Dirección General de Industria e Innovación Tecnológica

c/ José Cantalapiedra, s/n

E-47014 Valladolid

Tel.: (0034) 983 41 40 00

Fax (0034) 983 41 40 40

E-mail: delfín.prieto@cict.jcyl.es

| Comunidad Autónoma de Cataluña |
| --- |
| Departamento de Economía y Finanzas |
| Dirección General de Energía y Minas |
| c/ Provenza, 339 |
| E-08037 Barcelona |
| Tel.: (0034) 932 28 57 57 |
| Fax (0034) 934 39 39 96 |
| E-mail: arovira@gencat.net |

Comunidad Autónoma de Cataluña

Departamento de Economía y Finanzas

Dirección General de Energía y Minas

c/ Provenza, 339

E-08037 Barcelona

Tel.: (0034) 932 28 57 57

Fax (0034) 934 39 39 96

E-mail: arovira@gencat.net

| Comunidad Autónoma de Extremadura |
| --- |
| Consejería de Economía y Trabajo |
| Dirección General de Ordenación Industrial, Energía y Minas |
| Paseo de Roma, s/n |
| E-06800 Mérida, España |
| Tel.: (0034) 924 00 54 15 |
| Fax (0034) 924 00 56 01 |
| E-mail: mgarcia@eco.juntaex.es |

Comunidad Autónoma de Extremadura

Consejería de Economía y Trabajo

Dirección General de Ordenación Industrial, Energía y Minas

Paseo de Roma, s/n

E-06800 Mérida, España

Tel.: (0034) 924 00 54 15

Fax (0034) 924 00 56 01

E-mail: mgarcia@eco.juntaex.es

| Comunidad Autónoma de Galicia |
| --- |
| Consejería de Innovación e Industria |
| Edificio Advo, San Caetano, blq. 5-4a planta |
| E-15781 Santiago de Compostela |
| Tel.: (0034) 981 54 54 00 |
| Fax (0034) 981 95 71 92 |
| E-mail: carmen.vazquez.dominguez@xunta.es |

Comunidad Autónoma de Galicia

Consejería de Innovación e Industria

Edificio Advo, San Caetano, blq. 5-4a planta

E-15781 Santiago de Compostela

Tel.: (0034) 981 54 54 00

Fax (0034) 981 95 71 92

E-mail: carmen.vazquez.dominguez@xunta.es

| Comunidad Autónoma de La Rioja |
| --- |
| Consejería de Agricultura y Desarrollo Económico |
| Avda. de la Paz, 8-10 |
| E-26071 Logroño |
| Tel.: (0034) 941 29 12 82 |
| Fax (0034) 941 29 14 79 |
| E-mail: metrologia.legal@larioja.org |

Comunidad Autónoma de La Rioja

Consejería de Agricultura y Desarrollo Económico

Avda. de la Paz, 8-10

E-26071 Logroño

Tel.: (0034) 941 29 12 82

Fax (0034) 941 29 14 79

E-mail: metrologia.legal@larioja.org

| Comunidad Autónoma de Madrid |
| --- |
| Consejería de Economía y Consumo |
| Dirección General de industria, Energía y Minas |
| c/ Cardenal Marcelo Spínola, 14 |
| E-28016 Madrid |
| Tel.: (0034) 915 80 21 81 |
| Fax (0034) 915 80 21 03 |
| E-mail: Yolanda.izquierdo@madrid.org |

Comunidad Autónoma de Madrid

Consejería de Economía y Consumo

Dirección General de industria, Energía y Minas

c/ Cardenal Marcelo Spínola, 14

E-28016 Madrid

Tel.: (0034) 915 80 21 81

Fax (0034) 915 80 21 03

E-mail: Yolanda.izquierdo@madrid.org

| Comunidad Autónoma de Murcia |
| --- |
| Consejería de Economía, Industria e Innovación |
| Dirección General de Industria, Energía y Minas |
| c/Nuevas Tecnologías, s/n |
| Tel.: (0034) 968 36 20 13 |
| Fax (0034) 968 36 20 03 |
| E-mail: pedrolcones@carm.es |

Comunidad Autónoma de Murcia

Consejería de Economía, Industria e Innovación

Dirección General de Industria, Energía y Minas

c/Nuevas Tecnologías, s/n

Tel.: (0034) 968 36 20 13

Fax (0034) 968 36 20 03

E-mail: pedrolcones@carm.es

| Comunidad Autónoma de Navarra |
| --- |
| Departamento de Innovación, Empresa y Empleo |
| Servicio de Seguridad Industrial |
| Parque de Tomás Caballero, 1 |
| E-31005 Pamplona |
| Tel.: (0034) 848 42 76 45 |
| Fax (0034) 848 42 35 94 |
| E-mail: jayesaus@cfnavarra.es |

Comunidad Autónoma de Navarra

Departamento de Innovación, Empresa y Empleo

Servicio de Seguridad Industrial

Parque de Tomás Caballero, 1

E-31005 Pamplona

Tel.: (0034) 848 42 76 45

Fax (0034) 848 42 35 94

E-mail: jayesaus@cfnavarra.es

| Comunidad Autónoma del País Vasco |
| --- |
| Departamento de Industria, Comercio y Turismo |
| Viceconsejería de Comercio, Consumo y Seguridad Industrial |
| c/ Donostia-San Sebastián, 1 |
| E-01010 Vitoria-Gasteiz, |
| Tel.: (0034) 945 01 80 00 |
| Fax (0034) 848 42 35 94 |
| E-mail: Josefmi-munoz@ej-gv.es |

Comunidad Autónoma del País Vasco

Departamento de Industria, Comercio y Turismo

Viceconsejería de Comercio, Consumo y Seguridad Industrial

c/ Donostia-San Sebastián, 1

E-01010 Vitoria-Gasteiz,

Tel.: (0034) 945 01 80 00

Fax (0034) 848 42 35 94

E-mail: Josefmi-munoz@ej-gv.es

| Comunidad Autónoma de Valencia |
| --- |
| Consejería de Infraestructuras y Transporte |
| Dirección General de Energía |
| c/ Colón, 32 |
| E-45004 Valencia |
| Tel.: (0034) 963 86 60 00 |
| Fax (0034) 963 86 68 03 |
| E-mail: fabra.fer@gva.es |

Comunidad Autónoma de Valencia

Consejería de Infraestructuras y Transporte

Dirección General de Energía

c/ Colón, 32

E-45004 Valencia

Tel.: (0034) 963 86 60 00

Fax (0034) 963 86 68 03

E-mail: fabra.fer@gva.es

| Ciudad Autónoma de Ceuta |
| --- |
| Consejería de Fomento |
| Palacio de la Asamblea de la Ciudad de Ceuta |
| Pl. de África s/n |
| E-51001 Ceuta |
| Tel.: (0034) 956 52 82 00 |
| Fax (0034) 956 52 82 04 |
| E-mail: fomento@ceuta.es |

Ciudad Autónoma de Ceuta

Consejería de Fomento

Palacio de la Asamblea de la Ciudad de Ceuta

Pl. de África s/n

E-51001 Ceuta

Tel.: (0034) 956 52 82 00

Fax (0034) 956 52 82 04

E-mail: fomento@ceuta.es

FRANCE

| Institut de Radioprotection et de Sûreté Nucléaire (IRSN) |
| --- |
| Boîte postale 17 |
| 31, avenue de la Division Leclerc |
| Contact person: Mr Yann Billarand |
| BP 17 |
| F-92260 Fontenay-aux-Roses |
| Tel.: (0033)1 58 35 88 88 |
| Fax (0033)1 58 35 54 81 |
| E-mail: yann.billarand@irsn.fr |

Institut de Radioprotection et de Sûreté Nucléaire (IRSN)

Boîte postale 17

31, avenue de la Division Leclerc

Contact person: Mr Yann Billarand

BP 17

F-92260 Fontenay-aux-Roses

Tel.: (0033)1 58 35 88 88

Fax (0033)1 58 35 54 81

E-mail: yann.billarand@irsn.fr

ITALIA

National contact point:

| APAT (Agenzia per la Protezione dell'Ambiente e per i Servizi Tecnici) |
| --- |
| Dipartimento Nucleare, Rischio Tecnologico e Industriale |
| Via Vitaliano Brancati 48 |
| I-00144 Roma |
| Tel.: (0039) 06 5007 2254/(0039) 06 5007 2851 |
| Fax (0039) 06 5007 2941 |
| E-mail: joanne.wells@apat.it/Ministero dello Sviluppo Economico Dipartimento per la Competitività |

APAT (Agenzia per la Protezione dell'Ambiente e per i Servizi Tecnici)

Dipartimento Nucleare, Rischio Tecnologico e Industriale

Via Vitaliano Brancati 48

I-00144 Roma

Tel.: (0039) 06 5007 2254/(0039) 06 5007 2851

Fax (0039) 06 5007 2941

E-mail: joanne.wells@apat.it/Ministero dello Sviluppo Economico Dipartimento per la Competitività

| Direzione Generale per l'Energia e le Risorse Minerarie |
| --- |
| Ufficio B6 |
| Via Molise, 6 |
| I-00187 Roma |
| Tel.: (0039) 06 47052641 2531 2639 |
| Fax (0039) 06 47052847 |

Direzione Generale per l'Energia e le Risorse Minerarie

Ufficio B6

Via Molise, 6

I-00187 Roma

Tel.: (0039) 06 47052641 2531 2639

Fax (0039) 06 47052847

ΚΥΠΡΟΣ/CYPRUS

| Τμήμα Επιθεώρησης Εργασίας/Department of Labour Inspection |
| --- |
| Αρμόδιος: κ. Πανίκος Δημητριάδης/Contact person: Mr Panicos Demetriades |
| CY-1493 Λευκωσία/CY-1493 Nicosia |
| Tel.: (00357) 22 405623 |
| Fax (00357) 22 663788 |
| E-mail: pdemetriades@dli.mlsi.gov.cy |
| Website: http://www.mlsi.gov.cy/dli |

Τμήμα Επιθεώρησης Εργασίας/Department of Labour Inspection

Αρμόδιος: κ. Πανίκος Δημητριάδης/Contact person: Mr Panicos Demetriades

CY-1493 Λευκωσία/CY-1493 Nicosia

Tel.: (00357) 22 405623

Fax (00357) 22 663788

E-mail: pdemetriades@dli.mlsi.gov.cy

Website: http://www.mlsi.gov.cy/dli

LATVIJA

| Radiation Safety Centre |
| --- |
| Maskavas iela 165 |
| LV-1019 Rīga |
| Tel.: (00371) 67 03 26 60 |
| Fax (00371) 67 03 26 59 |
| E-mail: pasts@rdc.gov.lv; rdc@rdc.gov.lv |

Radiation Safety Centre

Maskavas iela 165

LV-1019 Rīga

Tel.: (00371) 67 03 26 60

Fax (00371) 67 03 26 59

E-mail: pasts@rdc.gov.lv; rdc@rdc.gov.lv

LIETUVA

| Radiacinės saugos centras |
| --- |
| Kalvarijų 153 |
| LT-08221 Vilnius |
| Tel.: (00370) 5 236 1936 |
| Fax 00370) 5 276 36 33 |
| E-mail: rsc@rsc.lt |

Radiacinės saugos centras

Kalvarijų 153

LT-08221 Vilnius

Tel.: (00370) 5 236 1936

Fax 00370) 5 276 36 33

E-mail: rsc@rsc.lt

LUXEMBOURG

| Directeur de la Santé |
| --- |
| Division de la Radioprotection |
| Contact person: Mr Patrick Majerus |
| Villa Louvigny-Allée Marconi |
| L-2120 Luxembourg |
| Tel.: (00352) 24 78 56 70 |
| Fax (00352) 46 75 22 |
| E-mail: secretariat.radioprotection@ms.etat.lu |
| patrick.majerus@ms.etat.lu |

Directeur de la Santé

Division de la Radioprotection

Contact person: Mr Patrick Majerus

Villa Louvigny-Allée Marconi

L-2120 Luxembourg

Tel.: (00352) 24 78 56 70

Fax (00352) 46 75 22

E-mail: secretariat.radioprotection@ms.etat.lu

patrick.majerus@ms.etat.lu

MAGYARORSZÁG

| Hungarian Atomic Energy Authority |
| --- |
| (Országos Atomenergia Hivatal) |
| Department of Nuclear and Radioactive Materials |
| Contact person: Horváth Kristóf |
| Office address: Fényes Adolf utca 4. |
| H-1036 Budapest |

Hungarian Atomic Energy Authority

(Országos Atomenergia Hivatal)

Department of Nuclear and Radioactive Materials

Contact person: Horváth Kristóf

Office address: Fényes Adolf utca 4.

H-1036 Budapest

| Mail address: PO Box 676 |
| --- |
| H-1539 Budapest |
| Tel.: (0036) 1 436 4911 |
| Fax (0036) 1 436 4843 |
| E-mail: haea@haea.gov.hu |

Mail address: PO Box 676

H-1539 Budapest

Tel.: (0036) 1 436 4911

Fax (0036) 1 436 4843

E-mail: haea@haea.gov.hu

MALTA

| Radiation Protection Board |
| --- |
| OHSA Building |
| 17, Triq Edgar Ferro |
| Pietà PTA 3153 Malta |
| Tel.: (00356) 21 247 677 |
| Fax (00356) 21 232 909 |
| E-mail: ohsa.rpb@gov.mt |

Radiation Protection Board

OHSA Building

17, Triq Edgar Ferro

Pietà PTA 3153 Malta

Tel.: (00356) 21 247 677

Fax (00356) 21 232 909

E-mail: ohsa.rpb@gov.mt

NEDERLAND

| SenterNovem Den Haag |
| --- |
| Team Stralingsbescherming |
| Postbus 93144 |
| 2509 AC Den Haag |
| Nederland |
| Tel.: (0031) 70 373 58 12 |
| Fax (0031) 70 373 51 00 |
| E-mail: stralingsbescherming@senternovem.nl |

SenterNovem Den Haag

Team Stralingsbescherming

Postbus 93144

2509 AC Den Haag

Nederland

Tel.: (0031) 70 373 58 12

Fax (0031) 70 373 51 00

E-mail: stralingsbescherming@senternovem.nl

ÖSTERREICH

National contact point:

| Zentrales Strahlenquellenregister |
| --- |
| Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft |
| Radetzkystraße 2 |
| A-1031 Wien |
| Tel: (0043) 1 711 00-4406 |
| Fax (0043) 1 712 23 31 |
| E-mail: strahlenregister@lebensministerium.at |
| www.strahlenregister.gv.at |

Zentrales Strahlenquellenregister

Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft

Radetzkystraße 2

A-1031 Wien

Tel: (0043) 1 711 00-4406

Fax (0043) 1 712 23 31

E-mail: strahlenregister@lebensministerium.at

www.strahlenregister.gv.at

Competent federal authority for medical sources:

| Bundesministerium für Gesundheit, Familie und Jugend |
| --- |
| Radetzkystraße 2 |
| A-1031 Wien |
| Tel.: (0043) 1 711 00-4126 |
| Fax (0043) 1 7186595 |

Bundesministerium für Gesundheit, Familie und Jugend

Radetzkystraße 2

A-1031 Wien

Tel.: (0043) 1 711 00-4126

Fax (0043) 1 7186595

Competent federal authority for non-medical sources:

| Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft |
| --- |
| Radetzkystraße 2 |
| A-1031 Wien |
| Tel.: (0043) 1 711 00-4194 |
| Fax (0043) 1 712 23 31 |
| E-mail: strahlenschutz@bmlfuw.gv.at |

Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft

Radetzkystraße 2

A-1031 Wien

Tel.: (0043) 1 711 00-4194

Fax (0043) 1 712 23 31

E-mail: strahlenschutz@bmlfuw.gv.at

POLSKA

Contact point:

| Państwowa Agencja Atomistyki |
| --- |
| Departament Nadzoru Zastosowań Promieniowania Jonizującego |
| Contact person: Tadeusz Dziubiak |
| Inspektor Dozoru Jądrowego |
| ul. Krucza 36 |
| PL-00-522 Warszawa |
| Tel.: +48 22 676 9707 ext. 26 |
| Fax +48 22 614 4252 |
| E-mail: tadeusz.dziubiak@paa.gov.pl |

Państwowa Agencja Atomistyki

Departament Nadzoru Zastosowań Promieniowania Jonizującego

Contact person: Tadeusz Dziubiak

Inspektor Dozoru Jądrowego

ul. Krucza 36

PL-00-522 Warszawa

Tel.: +48 22 676 9707 ext. 26

Fax +48 22 614 4252

E-mail: tadeusz.dziubiak@paa.gov.pl

Competent authority:

| Prezes Państwowej Agencji Atomistyki |
| --- |
| ul. Krucza 36 |
| PL-00-522 Warszawa |
| Tel.: +48 22 628 2722/+48 22 695 9800 |
| Fax +48 22 629 0164 |

Prezes Państwowej Agencji Atomistyki

ul. Krucza 36

PL-00-522 Warszawa

Tel.: +48 22 628 2722/+48 22 695 9800

Fax +48 22 629 0164

PORTUGAL

| Instituto Tecnológico Nuclear — ITN |
| --- |
| Estrada Nacional 10 |
| P-2686-953 Sacavém |
| Tel.: (00351) 21 994 60 10 |
| Fax (00351) 21 995 01 17 |
| E-mail: seccd@itn.pt |

Instituto Tecnológico Nuclear — ITN

Estrada Nacional 10

P-2686-953 Sacavém

Tel.: (00351) 21 994 60 10

Fax (00351) 21 995 01 17

E-mail: seccd@itn.pt

ROMÂNIA

| Comisia Națională pentru Controlul Activităților Nucleare |
| --- |
| 14th Libertatii Blvd, sector 5 |
| RO-050706 București |
| Tel.: (0040) 21 316 05 72 |
| Fax (0040) 21 317 38 87 |
| E-mail: vajda.borbala@cncan.ro |

Comisia Națională pentru Controlul Activităților Nucleare

14th Libertatii Blvd, sector 5

RO-050706 București

Tel.: (0040) 21 316 05 72

Fax (0040) 21 317 38 87

E-mail: vajda.borbala@cncan.ro

SLOVENIJA

For radioactive sources in medical and veterinary sectors:

| Ministrstvo za zdravje |
| --- |
| Uprava Republike Slovenije za varstvo pred sevanji |
| Ajdovščina 4 |
| SLO-1001 Ljubljana |
| Tel.: (00386) 1 47 88 709 |
| Fax (00386) 1 47 88 715 |
| E-mail: gp-ursvs.mz@gov.si |

Ministrstvo za zdravje

Uprava Republike Slovenije za varstvo pred sevanji

Ajdovščina 4

SLO-1001 Ljubljana

Tel.: (00386) 1 47 88 709

Fax (00386) 1 47 88 715

E-mail: gp-ursvs.mz@gov.si

For radioactive sources in other sectors (industry, research):

| Ministrstvo za okolje in prostor |
| --- |
| Uprava Republike Slovenije za jedrsko varnost |
| Železna cesta 16 |
| SLO-1001 Ljubljana |
| Tel.: (00386) 1 47 21 100 |
| Fax (00386) 1 472 1199 |
| E-mail: snsa@gov.si |

Ministrstvo za okolje in prostor

Uprava Republike Slovenije za jedrsko varnost

Železna cesta 16

SLO-1001 Ljubljana

Tel.: (00386) 1 47 21 100

Fax (00386) 1 472 1199

E-mail: snsa@gov.si

SLOVENSKO

| Public Health Authority of the Slovak Republic |
| --- |
| Trnavska cesta 52 |
| SK-826 45 Bratislava |
| Tel.: (00421) 2 44372619 |
| Fax (00421) 2 43372619 |
| E-mail: ragan@uvzsr.sk |

Public Health Authority of the Slovak Republic

Trnavska cesta 52

SK-826 45 Bratislava

Tel.: (00421) 2 44372619

Fax (00421) 2 43372619

E-mail: ragan@uvzsr.sk

SUOMI/FINLAND

| Säteilyturvakeskus (STUK) |
| --- |
| Laippatie 4/PL 14 |
| FI-00881 Helsinki |
| Tel.: (00358) 9 759 881 |
| Fax (00358) 9 759 88 500 |
| E-mail.: stuk@stuk.fi |
| http://www.stuk.fi/en_GB/ |

Säteilyturvakeskus (STUK)

Laippatie 4/PL 14

FI-00881 Helsinki

Tel.: (00358) 9 759 881

Fax (00358) 9 759 88 500

E-mail.: stuk@stuk.fi

http://www.stuk.fi/en_GB/

SVERIGE

| Strålsäkerhetsmyndigheten |
| --- |
| S-171 16 Stockholm |
| Tel.: (0046) 8 799 40 00 |
| Fax (0046) 8 799 40 10 |
| E-mail: registrator@ssm.se |

Strålsäkerhetsmyndigheten

S-171 16 Stockholm

Tel.: (0046) 8 799 40 00

Fax (0046) 8 799 40 10

E-mail: registrator@ssm.se

UNITED KINGDOM

For sites under the Nuclear Installations Act:

| EU Shipments Officer |
| --- |
| Health and Safety Executive |
| Nuclear Directorate |
| Redgrave Court |
| Building 4 NG |
| Merton Road |
| Bootle |
| Merseyside L20 7HS |
| United Kingdom |
| Tel.: (+44) 519 51 3359 |
| Fax (+44) 519 22 59 80/11 58 |
| E-mail: alison.curran@hse.gsi.gov.uk |

EU Shipments Officer

Health and Safety Executive

Nuclear Directorate

Redgrave Court

Building 4 NG

Merton Road

Bootle

Merseyside L20 7HS

United Kingdom

Tel.: (+44) 519 51 3359

Fax (+44) 519 22 59 80/11 58

E-mail: alison.curran@hse.gsi.gov.uk

For registrations under the Radioactive Substances Act 1993:

For England and Wales:

| The Environment Agency |
| --- |
| International Waste Shipments Team |
| Richard Fairclough House |
| Knutsford Road |
| Warrington WA4 1HT |
| United Kingdom |
| Tel.: (0044) 1925 54 22 65 |
| Fax (0044) 1925 54 21 05 |
| shipments@environment-agency.gov.uk |

The Environment Agency

International Waste Shipments Team

Richard Fairclough House

Knutsford Road

Warrington WA4 1HT

United Kingdom

Tel.: (0044) 1925 54 22 65

Fax (0044) 1925 54 21 05

shipments@environment-agency.gov.uk

For registrations under the Radioactive Substances Act 1993:

For Scotland:

| Radioactive Substances Policy Unit |
| --- |
| The Scottish Environment Protection Agency |
| Corporate Office |
| Erskine Court |
| Castle Business Park |
| Stirling FK9 4TR |
| United Kingdom |
| Tel.: (0044) 1786 45 77 00 |
| Fax (0044) 1786 44 44 68 85 |
| E-mail: radioactive.TFS@sepa.org.uk |

Radioactive Substances Policy Unit

The Scottish Environment Protection Agency

Corporate Office

Erskine Court

Castle Business Park

Stirling FK9 4TR

United Kingdom

Tel.: (0044) 1786 45 77 00

Fax (0044) 1786 44 44 68 85

E-mail: radioactive.TFS@sepa.org.uk

For Northern Ireland:

| Chief Radiochemical Inspector |
| --- |
| Department of the Environment |
| Northern Ireland |
| Northern Ireland Environment Agency |
| Industrial Pollution and Radiochemical Inspectorate |
| Klondyke Building |
| Gasworks Business Park |
| Lower Ormeau Road |
| Belfast BT7 2JA |
| United Kingdom |
| Tel.: (0044) 2890 56 93 05 |
| Fax (0044) 2890 56 92 63 |
| E-mail: ipri@doeni.gov.uk |

Chief Radiochemical Inspector

Department of the Environment

Northern Ireland

Northern Ireland Environment Agency

Industrial Pollution and Radiochemical Inspectorate

Klondyke Building

Gasworks Business Park

Lower Ormeau Road

Belfast BT7 2JA

United Kingdom

Tel.: (0044) 2890 56 93 05

Fax (0044) 2890 56 92 63

E-mail: ipri@doeni.gov.uk

---

(1)  OJ L 148, 19.6.1993, p. 1.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/7 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/7

---

Euro exchange rates (1)

18 February 2009

(2009/C 41/03)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2596 |
| JPY | Japanese yen | 116,83 |
| DKK | Danish krone | 7,4513 |
| GBP | Pound sterling | 0,8846 |
| SEK | Swedish krona | 11,1088 |
| CHF | Swiss franc | 1,4792 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,86 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 28,847 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 302,72 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7073 |
| PLN | Polish zloty | 4,7865 |
| RON | Romanian leu | 4,282 |
| TRY | Turkish lira | 2,1338 |
| AUD | Australian dollar | 1,9726 |
| CAD | Canadian dollar | 1,5882 |
| HKD | Hong Kong dollar | 9,768 |
| NZD | New Zealand dollar | 2,4691 |
| SGD | Singapore dollar | 1,9263 |
| KRW | South Korean won | 1 865,69 |
| ZAR | South African rand | 12,8353 |
| CNY | Chinese yuan renminbi | 8,6131 |
| HRK | Croatian kuna | 7,4323 |
| IDR | Indonesian rupiah | 15 178,18 |
| MYR | Malaysian ringgit | 4,607 |
| PHP | Philippine peso | 60,11 |
| RUB | Russian rouble | 45,3942 |
| THB | Thai baht | 44,546 |
| BRL | Brazilian real | 2,933 |
| MXN | Mexican peso | 18,4342 |
| INR | Indian rupee | 62,577 |

Currency

Exchange rate

USD

US dollar

1,2596

JPY

Japanese yen

116,83

DKK

Danish krone

7,4513

GBP

Pound sterling

0,8846

SEK

Swedish krona

11,1088

CHF

Swiss franc

1,4792

ISK

Iceland króna

NOK

Norwegian krone

8,86

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

28,847

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

302,72

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7073

PLN

Polish zloty

4,7865

RON

Romanian leu

4,282

TRY

Turkish lira

2,1338

AUD

Australian dollar

1,9726

CAD

Canadian dollar

1,5882

HKD

Hong Kong dollar

9,768

NZD

New Zealand dollar

2,4691

SGD

Singapore dollar

1,9263

KRW

South Korean won

1 865,69

ZAR

South African rand

12,8353

CNY

Chinese yuan renminbi

8,6131

HRK

Croatian kuna

7,4323

IDR

Indonesian rupiah

15 178,18

MYR

Malaysian ringgit

4,607

PHP

Philippine peso

60,11

RUB

Russian rouble

45,3942

THB

Thai baht

44,546

BRL

Brazilian real

2,933

MXN

Mexican peso

18,4342

INR

Indian rupee

62,577

---

(1)

Source: reference exchange rate published by the ECB.

---

| 19.2.2009 | EN | Official Journal of the European Union | C 41/8 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/8

---

Adoption of a reference document for the purpose of Council Directive 2008/1/EC concerning integrated pollution prevention and control (1)

(2009/C 41/04)

On 3 February 2009, the Commission adopted the complete text of the reference document on best available techniques for energy efficiency.

This document is available on the Internet site: http://eippcb.jrc.es

---

(1)  OJ L 24, 29.1.2008, p. 8.

---

NOTICES FROM MEMBER STATES

| 19.2.2009 | EN | Official Journal of the European Union | C 41/9 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/9

---

Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2009/C 41/05)

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| EN 556-1:2001/AC:2006 | | |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | — | |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | EN 980:2003 | 31.5.2010 |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | EN 1041:1998 | 31.8.2011 |
| CEN | EN ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | — | |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | EN 30993-4:1993 | Date expired
  (30.4.2003) |
| EN ISO 10993-4:2002/A1:2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | EN 30993-5:1994 | Date expired
  (30.11.1999) |
| CEN | EN ISO 10993-6:2007
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | EN 30993-6:1994 | Date expired
  (31.10.2007) |
| CEN | EN ISO 10993-9:1999
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | — | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | EN ISO 10993-10:1995 | Date expired
  (31.3.2003) |
| EN ISO 10993-10:2002/A1:2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-11:2006
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | EN ISO 10993-11:1995 | Date expired
  (28.2.2007) |
| CEN | EN ISO 10993-12:2007
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | EN ISO 10993-12:2004 | Date expired
  (31.5.2008) |
| CEN | EN ISO 10993-13:1998
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | — | |
| CEN | EN ISO 10993-16:1997
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | — | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | — | |
| CEN | EN ISO 10993-18:2005
  Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) | — | |
| CEN | EN ISO 11135-1:2007
  Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) | EN 550:1994 | 31.5.2010 |
| CEN | EN ISO 11137-1:2006
  Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11137-2:2007
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006) | — | |
| CEN | EN ISO 11138-2:2006
  Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) | — | |
| CEN | EN ISO 11138-3:2006
  Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) | — | |
| CEN | EN ISO 11140-1:2005
  Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | — | |
| CEN | EN ISO 11607-1:2006
  Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | EN 868-1:1997 | Date expired
  (30.4.2007) |
| CEN | EN ISO 11737-1:2006
  Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | EN 1174-1:1996
  EN 1174-2:1996
  EN 1174-3:1996 | Date expired
  (31.10.2006) |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2009 |
| EN ISO 13485:2003/AC:2007 | | |
| CEN | EN 13824:2004
  Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements | — | |
| CEN | EN ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | EN 540:1993 | Date expired
  (31.8.2003) |
| CEN | EN ISO 14155-2:2003
  Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) | — | |
| CEN | EN ISO 14937:2000
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) | — | |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | EN ISO 14971:2000 | 31.3.2010 |
| CEN | EN ISO 17665-1:2006
  Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) | EN 554:1994 | 31.8.2009 |
| CEN | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | — | |
| CEN | EN 45502-2-1:2004
  Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | — | |

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

(Note 1)

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

—

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

EN 1041:1998

31.8.2011

CEN

EN ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

—

CEN

EN ISO 10993-4:2002

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)

EN 30993-4:1993

Date expired

(30.4.2003)

EN ISO 10993-4:2002/A1:2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-5:1999

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

EN 30993-5:1994

Date expired

(30.11.1999)

CEN

EN ISO 10993-6:2007

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN 30993-6:1994

Date expired

(31.10.2007)

CEN

EN ISO 10993-9:1999

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

—

CEN

EN ISO 10993-10:2002

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)

EN ISO 10993-10:1995

Date expired

(31.3.2003)

EN ISO 10993-10:2002/A1:2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-11:2006

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 10993-11:1995

Date expired

(28.2.2007)

CEN

EN ISO 10993-12:2007

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

EN ISO 10993-12:2004

Date expired

(31.5.2008)

CEN

EN ISO 10993-13:1998

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

—

CEN

EN ISO 10993-16:1997

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

—

CEN

EN ISO 10993-17:2002

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

—

CEN

EN ISO 10993-18:2005

Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)

—

CEN

EN ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

EN 550:1994

31.5.2010

CEN

EN ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11137-2:2007

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006)

—

CEN

EN ISO 11138-2:2006

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

—

CEN

EN ISO 11138-3:2006

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

—

CEN

EN ISO 11140-1:2005

Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

—

CEN

EN ISO 11607-1:2006

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

EN 868-1:1997

Date expired

(30.4.2007)

CEN

EN ISO 11737-1:2006

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

EN 1174-1:1996

EN 1174-2:1996

EN 1174-3:1996

Date expired

(31.10.2006)

CEN

EN ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2009

EN ISO 13485:2003/AC:2007

CEN

EN 13824:2004

Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

—

CEN

EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)

EN 540:1993

Date expired

(31.8.2003)

CEN

EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)

—

CEN

EN ISO 14937:2000

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

—

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

CEN

EN ISO 17665-1:2006

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

EN 554:1994

31.8.2009

CEN

EN 45502-1:1997

Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer

—

CEN

EN 45502-2-1:2004

Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential 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 of the Council (2) amended by the Directive 98/48/EC (3), |
| --- | --- |

—

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 of the Council (2) amended by the Directive 98/48/EC (3),

| — | 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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu), |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu),

| — | Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org), |
| --- | --- |

—

Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org),

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org).

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---

| 19.2.2009 | EN | Official Journal of the European Union | C 41/13 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/13

---

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2009/C 41/06)

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| CEN | EN 285:2006 + A1:2008
  Sterilization — Steam sterilizers — Large sterilizers | EN 285:2006 | Date expired
  (30.11.2008) |
| CEN | EN 455-1:2000
  Medical gloves for single use — Part 1: Requirements and testing for freedom from holes | EN 455-1:1993 | Date expired
  (30.4.2001) |
| CEN | EN 455-2:2000
  Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) | EN 455-2:1995 | Date expired
  (30.4.2001) |
| CEN | EN 455-3:2006
  Medical gloves for single use — Part 3: Requirements and testing for biological evaluation | EN 455-3:1999 | Date expired
  (30.6.2007) |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices
  EN 556-1:2001/AC:2006 | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | — | |
| CEN | EN 794-1:1997
  Lung ventilators — Part 1: Particular requirements for critical care ventilators | — | |
| EN 794-1:1997/A1:2000 | Note 3 | Date expired
  (31.5.2001) |
| CEN | EN 794-3:1998
  Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators | — | |
| EN 794-3:1998/A1:2005 | Note 3 | Date expired
  (31.12.2005) |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | EN 980:2003 | 31.5.2010 |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | EN 1041:1998 | 31.8.2011 |
| CEN | EN 1060-1:1995
  Non-invasive sphygmomanometers — Part 1: General requirements | — | |
| EN 1060-1:1995/A1:2002 | Note 3 | Date expired
  (30.11.2002) |
| CEN | EN 1060-2:1995
  Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers | — | |
| CEN | EN 1060-3:1997
  Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | — | |
| EN 1060-3:1997/A1:2005 | Note 3 | Date expired
  (30.6.2006) |
| CEN | EN 1060-4:2004
  Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers | — | |
| CEN | EN 1089-3:2004
  Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding | EN 1089-3:1997 | Date expired
  (31.10.2004) |
| CEN | EN 1282-2:2005
  Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) | EN 1282-2:1997 | Date expired
  (31.12.2005) |
| CEN | EN 1422:1997
  Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods | — | |
| CEN | EN 1618:1997
  Catheters other than intravascular catheters — Test methods for common properties | — | |
| CEN | EN 1639:2004
  Dentistry — Medical devices for dentistry — Instruments | EN 1639:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1640:2004
  Dentistry — Medical devices for dentistry — Equipment | EN 1640:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1641:2004
  Dentistry — Medical devices for dentistry — Materials | EN 1641:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1642:2004
  Dentistry — Medical devices for dentistry — Dental implants | EN 1642:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1707:1996
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings | — | |
| CEN | EN 1782:1998
  Tracheal tubes and connectors | — | |
| CEN | EN 1789:2007
  Medical vehicles and their equipment — Road ambulances | EN 1789:1999 | Date expired
  (30.11.2007) |
| CEN | EN 1820:2005
  Anaesthetic reservoir bags (ISO 5362:2000, modified) | EN 1820:1997 | Date expired
  (31.12.2005) |
| CEN | EN 1865:1999
  Specifications for stretchers and other patient handling equipment used in road ambulances | — | |
| CEN | EN 1970:2000
  Adjustable beds for disabled persons — Requirements and test methods | — | |
| EN 1970:2000/A1:2005 | Note 3 | Date expired
  (30.9.2005) |
| CEN | EN 1985:1998
  Walking aids — General requirements and test methods | — | |
| CEN | EN ISO 3826-2:2008
  Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) | — | |
| CEN | EN ISO 3826-3:2007
  Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) | — | |
| CEN | EN ISO 4074:2002
  Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002) | EN 600:1996 | Date expired
  (31.8.2005) |
| CEN | EN ISO 4135:2001
  Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) | EN ISO 4135:1996 | Date expired
  (28.2.2002) |
| CEN | EN ISO 5356-1:2004
  Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004) | EN 1281-1:1997 | Date expired
  (30.11.2004) |
| CEN | EN ISO 5356-2:2007
  Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006) | EN 1281-2:1995 | Date expired
  (29.2.2008) |
| CEN | EN ISO 5359:2008
  Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) | EN 739:1998 | 30.6.2010 |
| CEN | EN ISO 5360:2007
  Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006) | EN 1280-1:1997 | Date expired
  (30.6.2008) |
| CEN | EN ISO 5366-1:2004
  Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) | EN 1282-1:1996 | Date expired
  (31.1.2005) |
| CEN | EN ISO 5840:2005
  Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) | EN 12006-1:1999 | Date expired
  (30.6.2006) |
| CEN | EN ISO 7197:2006
  Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006) | — | |
| CEN | EN ISO 7376:2003
  Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003) | EN 1819:1997 | Date expired
  (30.6.2004) |
| CEN | EN ISO 7396-1:2007
  Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) | EN 737-3:1998 | 30.4.2009 |
| CEN | EN ISO 7396-2:2007
  Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) | EN 737-2:1998 | 30.4.2009 |
| CEN | EN ISO 7439:2002
  Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002) | — | |
| CEN | EN ISO 7886-3:2005
  Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) | — | |
| CEN | EN ISO 7886-4:2006
  Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) | — | |
| CEN | EN ISO 8185:2007
  Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007) | EN ISO 8185:1997 | Date expired
  (31.1.2008) |
| CEN | EN ISO 8359:1996
  Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) | — | |
| CEN | EN ISO 8536-4:2007
  Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007) | — | |
| CEN | EN ISO 8835-2:2007
  Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) | EN 740:1998 | 31.5.2009 |
| CEN | EN ISO 8835-3:2007
  Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) | EN 740:1998 | 31.5.2009 |
| CEN | EN ISO 8835-4:2004
  Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
  EN ISO 8835-4:2004/AC:2006 | — | |
| CEN | EN ISO 8835-5:2004
  Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
  EN ISO 8835-5:2004/AC:2006 | — | |
| CEN | EN ISO 9170-1:2008
  Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) | EN 737-1:1998 | 31.7.2010 |
| CEN | EN ISO 9170-2:2008
  Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) | EN 737-4:1998 | 31.7.2010 |
| CEN | EN ISO 9360-1:2000
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) | — | |
| CEN | EN ISO 9360-2:2002
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) | — | |
| CEN | EN ISO 9713:2004
  Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) | — | |
| CEN | EN ISO 9919:2005
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) | EN 865:1997 | Date expired
  (30.9.2005) |
| CEN | EN ISO 10079-1:1999
  Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) | EN ISO 10079-1:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-2:1999
  Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) | EN ISO 10079-2:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-3:1999
  Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999) | EN ISO 10079-3:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10328:2006
  Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006) | — | |
| CEN | EN ISO 10524-1:2006
  Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) | EN 738-1:1997 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-2:2006
  Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) | EN 738-2:1998 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-3:2006
  Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) | EN 738-3:1998 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-4:2008
  Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008) | EN 738-4:1998 | 30.6.2010 |
| CEN | EN ISO 10535:2006
  Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006) | EN ISO 10535:1998 | Date expired
  (30.6.2007) |
| CEN | EN ISO 10555-1:1996
  Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995) | — | |
| EN ISO 10555-1:1996/A1:1999 | Note 3 | Date expired
  (31.1.2000) |
| EN ISO 10555-1:1996/A2:2004 | Note 3 | Date expired
  (30.11.2004) |
| CEN | EN ISO 10651-2:2004
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) | EN 794-2:1997 | Date expired
  (31.1.2005) |
| CEN | EN ISO 10651-4:2002
  Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | — | |
| CEN | EN ISO 10651-6:2004
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) | — | |
| CEN | EN ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | — | |
| CEN | EN ISO 10993-3:2003
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) | EN 30993-3:1993 | Date expired
  (30.4.2004) |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | EN 30993-4:1993 | Date expired
  (30.4.2003) |
| EN ISO 10993-4:2002/A1:2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | EN 30993-5:1994 | Date expired
  (30.11.1999) |
| CEN | EN ISO 10993-6:2007
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | EN 30993-6:1994 | Date expired
  (31.10.2007) |
| CEN | EN ISO 10993-7:2008
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) | — | |
| CEN | EN ISO 10993-9:1999
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | — | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | EN ISO 10993-10:1995 | Date expired
  (31.3.2003) |
| EN ISO 10993-10:2002/A1:2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-11:2006
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | EN ISO 10993-11:1995 | Date expired
  (28.2.2007) |
| CEN | EN ISO 10993-12:2007
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | EN ISO 10993-12:2004 | Date expired
  (31.5.2008) |
| CEN | EN ISO 10993-13:1998
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | — | |
| CEN | EN ISO 10993-14:2001
  Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) | — | |
| CEN | EN ISO 10993-15:2000
  Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) | — | |
| CEN | EN ISO 10993-16:1997
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | — | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | — | |
| CEN | EN ISO 10993-18:2005
  Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) | — | |
| CEN | EN ISO 11135-1:2007
  Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) | EN 550:1994 | 31.5.2010 |
| CEN | EN ISO 11137-1:2006
  Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11137-2:2007
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006) | — | |
| CEN | EN ISO 11138-2:2006
  Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) | — | |
| CEN | EN ISO 11138-3:2006
  Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) | — | |
| CEN | EN ISO 11140-1:2005
  Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | EN 867-2:1997 | Date expired
  (31.1.2006) |
| CEN | EN ISO 11140-3:2007
  Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007) | EN 867-3:1997 | Date expired
  (30.9.2007) |
| CEN | EN ISO 11197:2004
  Medical supply units (ISO 11197:2004) | EN 793:1997 | Date expired
  (30.6.2005) |
| CEN | EN ISO 11607-1:2006
  Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | EN 868-1:1997 | Date expired
  (30.4.2007) |
| CEN | EN ISO 11607-2:2006
  Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) | — | |
| CEN | EN ISO 11737-1:2006
  Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | EN 1174-1:1996
  EN 1174-2:1996
  EN 1174-3:1996 | Date expired
  (31.10.2006) |
| CEN | EN ISO 11810-2:2007
  Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007) | — | |
| CEN | EN ISO 11979-8:2006
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) | EN 13503-8:2000 | Date expired
  (31.1.2007) |
| CEN | EN ISO 11990:2003
  Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) | EN ISO 11990:1999 | Date expired
  (31.10.2003) |
| CEN | EN 12006-2:1998
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits | — | |
| CEN | EN 12006-3:1998
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices | — | |
| CEN | EN 12182:1999
  Technical aids for disabled persons — General requirements and test methods | — | |
| EN 12322:1999/A1:2001 | Note 3 | Date expired
  (30.4.2002) |
| CEN | EN 12342:1998
  Breathing tubes intended for use with anaesthetic apparatus and ventilators | — | |
| CEN | EN 12470-1:2000
  Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device | — | |
| CEN | EN 12470-2:2000
  Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers | — | |
| CEN | EN 12470-3:2000
  Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | — | |
| CEN | EN 12470-4:2000
  Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement | — | |
| CEN | EN 12470-5:2003
  Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device) | — | |
| CEN | EN ISO 12870:2004
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004)
  EN ISO 12870:2004/AC:2005 | EN ISO 12870:1997 | Date expired
  (28.2.2005) |
| CEN | EN 13014:2000
  Connections for gas sampling tubes to anaesthetic and respiratory equipment | — | |
| CEN | EN 13060:2004
  Small steam sterilizers | — | |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)
  EN ISO 13485:2003/AC:2007 | EN 46003:1999
  EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2009 |
| CEN | EN 13544-1:2007
  Respiratory therapy equipment — Part 1: Nebulizing systems and their components | EN 13544-1:2001 | Date expired
  (31.10.2007) |
| CEN | EN 13544-2:2002
  Respiratory therapy equipment — Part 2: Tubing and connectors | — | |
| CEN | EN 13544-3:2001
  Respiratory therapy equipment — Part 3: Air entrainment devices | — | |
| CEN | EN 13624:2003
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) | — | |
| CEN | EN 13718-1:2008
  Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances | EN 13718-1:2002 | 28.2.2009 |
| CEN | EN 13726-1:2002
  Test methods for primary wound dressings — Part 1: Aspects of absorbency | — | |
| CEN | EN 13726-2:2002
  Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings | — | |
| CEN | EN 13727:2003
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) | — | |
| CEN | EN 13795-1:2002
  Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products | — | |
| CEN | EN 13795-2:2004
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods | — | |
| CEN | EN 13795-3:2006
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels | — | |
| CEN | EN 13824:2004
  Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements | — | |
| CEN | EN 13867:2002
  Concentrates for haemodialysis and related therapies | — | |
| CEN | EN 13976-1:2003
  Rescue systems — Transportation of incubators — Part 1: Interface conditions | — | |
| CEN | EN 13976-2:2003
  Rescue systems — Transportation of incubators — Part 2: System requirements | — | |
| CEN | EN 14079:2003
  Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | — | |
| CEN | EN ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | EN 540:1993 | Date expired
  (31.8.2003) |
| CEN | EN ISO 14155-2:2003
  Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) | — | |
| CEN | EN ISO 14160:1998
  Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998) | — | |
| CEN | EN 14180:2003
  Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing | — | |
| CEN | EN 14348:2005
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1) | — | |
| CEN | EN ISO 14408:2005
  Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) | — | |
| CEN | EN ISO 14534:2002
  Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002) | EN ISO 14534:1997 | Date expired
  (31.12.2002) |
| CEN | EN 14561:2006
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) | — | |
| CEN | EN 14562:2006
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) | — | |
| CEN | EN 14563:2008
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area — Test method and requirements (phase 2, step 2) | — | |
| CEN | EN ISO 14602:1998
  Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:1998) | — | |
| CEN | EN ISO 14607:2007
  Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007) | — | |
| CEN | EN ISO 14630:2008
  Non-active surgical implants — General requirements (ISO 14630:2008) | EN ISO 14630:2005 | Date expired
  (31.7.2008) |
| CEN | EN 14683:2005
  Surgical masks — Requirements and test methods | — | |
| CEN | EN ISO 14889:2003
  Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) | EN ISO 14889:1997 | Date expired
  (30.11.2003) |
| CEN | EN 14931:2006
  Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing | — | |
| CEN | EN ISO 14937:2000
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) | — | |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | EN ISO 14971:2000 | 31.3.2010 |
| CEN | EN ISO 15001:2004
  Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003) | — | |
| CEN | EN ISO 15002:2008
  Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) | EN 13220:1998 | 31.7.2010 |
| CEN | EN ISO 15004-1:2006
  Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) | EN ISO 15004:1997 | Date expired
  (31.12.2006) |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | — | |
| EN ISO 15225:2000/A1:2004 | Note 3 | Date expired
  (31.8.2004) |
| CEN | EN 15424:2007
  Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices | — | |
| CEN | EN 15546-1:2008
  Small bore connectors for liquids and gases in healthcare applications — Part 1: General requirements | — | |
| CEN | EN ISO 15747:2005
  Plastics containers for intravenous injection (ISO 15747:2003) | — | |
| CEN | EN ISO 15883-1:2006
  Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) | — | |
| CEN | EN ISO 15883-2:2006
  Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) | — | |
| CEN | EN ISO 15883-3:2006
  Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) | — | |
| CEN | EN ISO 15883-4:2008
  Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) | — | |
| CEN | EN ISO 16061:2008
  Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008) | EN 12011:1998 | 30.6.2009 |
| CEN | EN ISO 16201:2006
  Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006) | — | |
| CEN | EN ISO 17510-1:2007
  Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) | EN ISO 17510-1:2002 | Date expired
  (30.4.2008) |
| CEN | EN ISO 17510-2:2007
  Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007) | EN ISO 17510-2:2003 | Date expired
  (30.4.2008) |
| CEN | EN ISO 17664:2004
  Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) | — | |
| CEN | EN ISO 17665-1:2006
  Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) | EN 554:1994 | 31.8.2009 |
| CEN | EN ISO 18777:2005
  Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) | — | |
| CEN | EN ISO 18778:2005
  Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) | — | |
| CEN | EN ISO 18779:2005
  Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005) | — | |
| CEN | EN ISO 19054:2006
  Rail systems for supporting medical equipment (ISO 19054:2005) | EN 12218:1998 | Date expired
  (30.6.2008) |
| CEN | EN 20594-1:1993
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) | — | |
| EN 20594-1:1993/A1:1997 | Note 3 | Date expired
  (31.5.1998) |
| CEN | EN ISO 21171:2006
  Medical gloves — Determination of removable surface powder (ISO 21171:2006) | — | |
| CEN | EN ISO 21534:2007
  Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007) | EN 12010:1998 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21535:2007
  Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007) | EN 12563:1998 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21536:2007
  Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007) | EN 12564:1998 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21647:2004
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
  EN ISO 21647:2004/AC:2006 | EN 12598:1999
  EN 864:1996
  EN ISO 11196:1997 | Date expired
  (31.5.2005) |
| CEN | EN ISO 21649:2006
  Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006) | — | |
| CEN | EN ISO 21969:2006
  High-pressure flexible connections for use with medical gas systems (ISO 21969:2005) | EN 13221:2000 | Date expired
  (31.12.2007) |
| CEN | EN ISO 22442-1:2007
  Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007) | EN 12442-1:2000 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22442-2:2007
  Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) | EN 12442-2:2000 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22442-3:2007
  Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) | EN 12442-3:2000 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22523:2006
  External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006) | EN 12523:1999 | Date expired
  (30.4.2007) |
| CEN | EN ISO 22610:2006
  Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) | — | |
| CEN | EN ISO 22612:2005
  Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005) | — | |
| CEN | EN ISO 22675:2006
  Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006) | — | |
| CEN | EN ISO 23328-1:2008
  Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003) | EN 13328-1:2001 | Date expired
  (30.9.2008) |
| CEN | EN ISO 23328-2:2008
  Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002) | EN 13328-2:2002 | Date expired
  (30.9.2008) |
| CEN | EN ISO 23747:2007
  Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) | EN 13826:2003 | Date expired
  (31.1.2008) |
| CEN | EN ISO 25539-1:2008
  Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) | EN 14299:2004 | 30.9.2011 |
| CEN | EN ISO 25539-2:2008
  Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008) | EN 14299:2004 | 30.9.2011 |
| CEN | EN 27740:1992
  Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | — | |
| EN 27740:1992/A1:1997 | Note 3 | Date expired
  (31.5.1998) |

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

(Note 1)

CEN

EN 285:2006 + A1:2008

Sterilization — Steam sterilizers — Large sterilizers

EN 285:2006

Date expired

(30.11.2008)

CEN

EN 455-1:2000

Medical gloves for single use — Part 1: Requirements and testing for freedom from holes

EN 455-1:1993

Date expired

(30.4.2001)

CEN

EN 455-2:2000

Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)

EN 455-2:1995

Date expired

(30.4.2001)

CEN

EN 455-3:2006

Medical gloves for single use — Part 3: Requirements and testing for biological evaluation

EN 455-3:1999

Date expired

(30.6.2007)

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

EN 556-1:2001/AC:2006

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

—

CEN

EN 794-1:1997

Lung ventilators — Part 1: Particular requirements for critical care ventilators

—

EN 794-1:1997/A1:2000

Note 3

Date expired

(31.5.2001)

CEN

EN 794-3:1998

Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators

—

EN 794-3:1998/A1:2005

Note 3

Date expired

(31.12.2005)

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

EN 1041:1998

31.8.2011

CEN

EN 1060-1:1995

Non-invasive sphygmomanometers — Part 1: General requirements

—

EN 1060-1:1995/A1:2002

Note 3

Date expired

(30.11.2002)

CEN

EN 1060-2:1995

Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers

—

CEN

EN 1060-3:1997

Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

—

EN 1060-3:1997/A1:2005

Note 3

Date expired

(30.6.2006)

CEN

EN 1060-4:2004

Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

—

CEN

EN 1089-3:2004

Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding

EN 1089-3:1997

Date expired

(31.10.2004)

CEN

EN 1282-2:2005

Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

EN 1282-2:1997

Date expired

(31.12.2005)

CEN

EN 1422:1997

Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods

—

CEN

EN 1618:1997

Catheters other than intravascular catheters — Test methods for common properties

—

CEN

EN 1639:2004

Dentistry — Medical devices for dentistry — Instruments

EN 1639:1996

Date expired

(31.12.2004)

CEN

EN 1640:2004

Dentistry — Medical devices for dentistry — Equipment

EN 1640:1996

Date expired

(31.12.2004)

CEN

EN 1641:2004

Dentistry — Medical devices for dentistry — Materials

EN 1641:1996

Date expired

(31.12.2004)

CEN

EN 1642:2004

Dentistry — Medical devices for dentistry — Dental implants

EN 1642:1996

Date expired

(31.12.2004)

CEN

EN 1707:1996

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings

—

CEN

EN 1782:1998

Tracheal tubes and connectors

—

CEN

EN 1789:2007

Medical vehicles and their equipment — Road ambulances

EN 1789:1999

Date expired

(30.11.2007)

CEN

EN 1820:2005

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 1820:1997

Date expired

(31.12.2005)

CEN

EN 1865:1999

Specifications for stretchers and other patient handling equipment used in road ambulances

—

CEN

EN 1970:2000

Adjustable beds for disabled persons — Requirements and test methods

—

EN 1970:2000/A1:2005

Note 3

Date expired

(30.9.2005)

CEN

EN 1985:1998

Walking aids — General requirements and test methods

—

CEN

EN ISO 3826-2:2008

Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

—

CEN

EN ISO 3826-3:2007

Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

—

CEN

EN ISO 4074:2002

Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002)

EN 600:1996

Date expired

(31.8.2005)

CEN

EN ISO 4135:2001

Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001)

EN ISO 4135:1996

Date expired

(28.2.2002)

CEN

EN ISO 5356-1:2004

Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004)

EN 1281-1:1997

Date expired

(30.11.2004)

CEN

EN ISO 5356-2:2007

Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

EN 1281-2:1995

Date expired

(29.2.2008)

CEN

EN ISO 5359:2008

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

EN 739:1998

30.6.2010

CEN

EN ISO 5360:2007

Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006)

EN 1280-1:1997

Date expired

(30.6.2008)

CEN

EN ISO 5366-1:2004

Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN 1282-1:1996

Date expired

(31.1.2005)

CEN

EN ISO 5840:2005

Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)

EN 12006-1:1999

Date expired

(30.6.2006)

CEN

EN ISO 7197:2006

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)

—

CEN

EN ISO 7376:2003

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003)

EN 1819:1997

Date expired

(30.6.2004)

CEN

EN ISO 7396-1:2007

Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN 737-3:1998

30.4.2009

CEN

EN ISO 7396-2:2007

Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

EN 737-2:1998

30.4.2009

CEN

EN ISO 7439:2002

Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002)

—

CEN

EN ISO 7886-3:2005

Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

—

CEN

EN ISO 7886-4:2006

Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

—

CEN

EN ISO 8185:2007

Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007)

EN ISO 8185:1997

Date expired

(31.1.2008)

CEN

EN ISO 8359:1996

Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)

—

CEN

EN ISO 8536-4:2007

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)

—

CEN

EN ISO 8835-2:2007

Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

EN 740:1998

31.5.2009

CEN

EN ISO 8835-3:2007

Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

EN 740:1998

31.5.2009

CEN

EN ISO 8835-4:2004

Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

EN ISO 8835-4:2004/AC:2006

—

CEN

EN ISO 8835-5:2004

Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

EN ISO 8835-5:2004/AC:2006

—

CEN

EN ISO 9170-1:2008

Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)

EN 737-1:1998

31.7.2010

CEN

EN ISO 9170-2:2008

Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN 737-4:1998

31.7.2010

CEN

EN ISO 9360-1:2000

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

—

CEN

EN ISO 9360-2:2002

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

—

CEN

EN ISO 9713:2004

Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002)

—

CEN

EN ISO 9919:2005

Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

EN 865:1997

Date expired

(30.9.2005)

CEN

EN ISO 10079-1:1999

Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999)

EN ISO 10079-1:1996

Date expired

(29.2.2000)

CEN

EN ISO 10079-2:1999

Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999)

EN ISO 10079-2:1996

Date expired

(29.2.2000)

CEN

EN ISO 10079-3:1999

Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10079-3:1996

Date expired

(29.2.2000)

CEN

EN ISO 10328:2006

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006)

—

CEN

EN ISO 10524-1:2006

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

EN 738-1:1997

Date expired

(31.10.2008)

CEN

EN ISO 10524-2:2006

Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

EN 738-2:1998

Date expired

(31.10.2008)

CEN

EN ISO 10524-3:2006

Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN 738-3:1998

Date expired

(31.10.2008)

CEN

EN ISO 10524-4:2008

Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN 738-4:1998

30.6.2010

CEN

EN ISO 10535:2006

Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006)

EN ISO 10535:1998

Date expired

(30.6.2007)

CEN

EN ISO 10555-1:1996

Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995)

—

EN ISO 10555-1:1996/A1:1999

Note 3

Date expired

(31.1.2000)

EN ISO 10555-1:1996/A2:2004

Note 3

Date expired

(30.11.2004)

CEN

EN ISO 10651-2:2004

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

EN 794-2:1997

Date expired

(31.1.2005)

CEN

EN ISO 10651-4:2002

Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

—

CEN

EN ISO 10651-6:2004

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

—

CEN

EN ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

—

CEN

EN ISO 10993-3:2003

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

EN 30993-3:1993

Date expired

(30.4.2004)

CEN

EN ISO 10993-4:2002

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)

EN 30993-4:1993

Date expired

(30.4.2003)

EN ISO 10993-4:2002/A1:2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-5:1999

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

EN 30993-5:1994

Date expired

(30.11.1999)

CEN

EN ISO 10993-6:2007

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN 30993-6:1994

Date expired

(31.10.2007)

CEN

EN ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

—

CEN

EN ISO 10993-9:1999

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

—

CEN

EN ISO 10993-10:2002

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)

EN ISO 10993-10:1995

Date expired

(31.3.2003)

EN ISO 10993-10:2002/A1:2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-11:2006

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 10993-11:1995

Date expired

(28.2.2007)

CEN

EN ISO 10993-12:2007

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

EN ISO 10993-12:2004

Date expired

(31.5.2008)

CEN

EN ISO 10993-13:1998

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

—

CEN

EN ISO 10993-14:2001

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

—

CEN

EN ISO 10993-15:2000

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

—

CEN

EN ISO 10993-16:1997

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

—

CEN

EN ISO 10993-17:2002

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

—

CEN

EN ISO 10993-18:2005

Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)

—

CEN

EN ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

EN 550:1994

31.5.2010

CEN

EN ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11137-2:2007

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006)

—

CEN

EN ISO 11138-2:2006

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

—

CEN

EN ISO 11138-3:2006

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

—

CEN

EN ISO 11140-1:2005

Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

EN 867-2:1997

Date expired

(31.1.2006)

CEN

EN ISO 11140-3:2007

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

EN 867-3:1997

Date expired

(30.9.2007)

CEN

EN ISO 11197:2004

Medical supply units (ISO 11197:2004)

EN 793:1997

Date expired

(30.6.2005)

CEN

EN ISO 11607-1:2006

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

EN 868-1:1997

Date expired

(30.4.2007)

CEN

EN ISO 11607-2:2006

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

—

CEN

EN ISO 11737-1:2006

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

EN 1174-1:1996

EN 1174-2:1996

EN 1174-3:1996

Date expired

(31.10.2006)

CEN

EN ISO 11810-2:2007

Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007)

—

CEN

EN ISO 11979-8:2006

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006)

EN 13503-8:2000

Date expired

(31.1.2007)

CEN

EN ISO 11990:2003

Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

EN ISO 11990:1999

Date expired

(31.10.2003)

CEN

EN 12006-2:1998

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits

—

CEN

EN 12006-3:1998

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices

—

CEN

EN 12182:1999

Technical aids for disabled persons — General requirements and test methods

—

EN 12322:1999/A1:2001

Note 3

Date expired

(30.4.2002)

CEN

EN 12342:1998

Breathing tubes intended for use with anaesthetic apparatus and ventilators

—

CEN

EN 12470-1:2000

Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device

—

CEN

EN 12470-2:2000

Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers

—

CEN

EN 12470-3:2000

Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

—

CEN

EN 12470-4:2000

Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement

—

CEN

EN 12470-5:2003

Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device)

—

CEN

EN ISO 12870:2004

Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004)

EN ISO 12870:2004/AC:2005

EN ISO 12870:1997

Date expired

(28.2.2005)

CEN

EN 13014:2000

Connections for gas sampling tubes to anaesthetic and respiratory equipment

—

CEN

EN 13060:2004

Small steam sterilizers

—

CEN

EN ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13485:2003/AC:2007

EN 46003:1999

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2009

CEN

EN 13544-1:2007

Respiratory therapy equipment — Part 1: Nebulizing systems and their components

EN 13544-1:2001

Date expired

(31.10.2007)

CEN

EN 13544-2:2002

Respiratory therapy equipment — Part 2: Tubing and connectors

—

CEN

EN 13544-3:2001

Respiratory therapy equipment — Part 3: Air entrainment devices

—

CEN

EN 13624:2003

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)

—

CEN

EN 13718-1:2008

Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances

EN 13718-1:2002

28.2.2009

CEN

EN 13726-1:2002

Test methods for primary wound dressings — Part 1: Aspects of absorbency

—

CEN

EN 13726-2:2002

Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings

—

CEN

EN 13727:2003

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)

—

CEN

EN 13795-1:2002

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products

—

CEN

EN 13795-2:2004

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods

—

CEN

EN 13795-3:2006

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels

—

CEN

EN 13824:2004

Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

—

CEN

EN 13867:2002

Concentrates for haemodialysis and related therapies

—

CEN

EN 13976-1:2003

Rescue systems — Transportation of incubators — Part 1: Interface conditions

—

CEN

EN 13976-2:2003

Rescue systems — Transportation of incubators — Part 2: System requirements

—

CEN

EN 14079:2003

Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

—

CEN

EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)

EN 540:1993

Date expired

(31.8.2003)

CEN

EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)

—

CEN

EN ISO 14160:1998

Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

—

CEN

EN 14180:2003

Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing

—

CEN

EN 14348:2005

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1)

—

CEN

EN ISO 14408:2005

Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005)

—

CEN

EN ISO 14534:2002

Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002)

EN ISO 14534:1997

Date expired

(31.12.2002)

CEN

EN 14561:2006

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)

—

CEN

EN 14562:2006

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)

—

CEN

EN 14563:2008

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area — Test method and requirements (phase 2, step 2)

—

CEN

EN ISO 14602:1998

Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:1998)

—

CEN

EN ISO 14607:2007

Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)

—

CEN

EN ISO 14630:2008

Non-active surgical implants — General requirements (ISO 14630:2008)

EN ISO 14630:2005

Date expired

(31.7.2008)

CEN

EN 14683:2005

Surgical masks — Requirements and test methods

—

CEN

EN ISO 14889:2003

Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003)

EN ISO 14889:1997

Date expired

(30.11.2003)

CEN

EN 14931:2006

Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing

—

CEN

EN ISO 14937:2000

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

—

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

CEN

EN ISO 15001:2004

Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003)

—

CEN

EN ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

EN 13220:1998

31.7.2010

CEN

EN ISO 15004-1:2006

Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

EN ISO 15004:1997

Date expired

(31.12.2006)

CEN

EN ISO 15225:2000

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

—

EN ISO 15225:2000/A1:2004

Note 3

Date expired

(31.8.2004)

CEN

EN 15424:2007

Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

—

CEN

EN 15546-1:2008

Small bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

—

CEN

EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)

—

CEN

EN ISO 15883-1:2006

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

—

CEN

EN ISO 15883-2:2006

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

—

CEN

EN ISO 15883-3:2006

Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

—

CEN

EN ISO 15883-4:2008

Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

—

CEN

EN ISO 16061:2008

Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008)

EN 12011:1998

30.6.2009

CEN

EN ISO 16201:2006

Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006)

—

CEN

EN ISO 17510-1:2007

Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

EN ISO 17510-1:2002

Date expired

(30.4.2008)

CEN

EN ISO 17510-2:2007

Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007)

EN ISO 17510-2:2003

Date expired

(30.4.2008)

CEN

EN ISO 17664:2004

Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

—

CEN

EN ISO 17665-1:2006

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

EN 554:1994

31.8.2009

CEN

EN ISO 18777:2005

Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005)

—

CEN

EN ISO 18778:2005

Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005)

—

CEN

EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005)

—

CEN

EN ISO 19054:2006

Rail systems for supporting medical equipment (ISO 19054:2005)

EN 12218:1998

Date expired

(30.6.2008)

CEN

EN 20594-1:1993

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986)

—

EN 20594-1:1993/A1:1997

Note 3

Date expired

(31.5.1998)

CEN

EN ISO 21171:2006

Medical gloves — Determination of removable surface powder (ISO 21171:2006)

—

CEN

EN ISO 21534:2007

Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007)

EN 12010:1998

Date expired

(31.3.2008)

CEN

EN ISO 21535:2007

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007)

EN 12563:1998

Date expired

(31.3.2008)

CEN

EN ISO 21536:2007

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)

EN 12564:1998

Date expired

(31.3.2008)

CEN

EN ISO 21647:2004

Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)

EN ISO 21647:2004/AC:2006

EN 12598:1999

EN 864:1996

EN ISO 11196:1997

Date expired

(31.5.2005)

CEN

EN ISO 21649:2006

Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006)

—

CEN

EN ISO 21969:2006

High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)

EN 13221:2000

Date expired

(31.12.2007)

CEN

EN ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)

EN 12442-1:2000

Date expired

(30.6.2008)

CEN

EN ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

EN 12442-2:2000

Date expired

(30.6.2008)

CEN

EN ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

EN 12442-3:2000

Date expired

(30.6.2008)

CEN

EN ISO 22523:2006

External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006)

EN 12523:1999

Date expired

(30.4.2007)

CEN

EN ISO 22610:2006

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)

—

CEN

EN ISO 22612:2005

Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005)

—

CEN

EN ISO 22675:2006

Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006)

—

CEN

EN ISO 23328-1:2008

Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

EN 13328-1:2001

Date expired

(30.9.2008)

CEN

EN ISO 23328-2:2008

Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002)

EN 13328-2:2002

Date expired

(30.9.2008)

CEN

EN ISO 23747:2007

Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

EN 13826:2003

Date expired

(31.1.2008)

CEN

EN ISO 25539-1:2008

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

EN 14299:2004

30.9.2011

CEN

EN ISO 25539-2:2008

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008)

EN 14299:2004

30.9.2011

CEN

EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

—

EN 27740:1992/A1:1997

Note 3

Date expired

(31.5.1998)

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential 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 of the Council (2) amended by the Directive 98/48/EC (3), |
| --- | --- |

—

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 of the Council (2) amended by the Directive 98/48/EC (3),

| — | 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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu), |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu),

| — | Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org), |
| --- | --- |

—

Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org),

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org).

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---

| 19.2.2009 | EN | Official Journal of the European Union | C 41/27 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/27

---

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2009/C 41/07)

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| CEN | EN 375:2001
  Information supplied by the manufacturer with in vitro diagnostic reagents for professional use | — | |
| CEN | EN 376:2002
  Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing | — | |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| EN 556-1:2001/AC:2006 | | |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | — | |
| CEN | EN 591:2001
  Instructions for use for in vitro diagnostic instruments for professional use | — | |
| CEN | EN 592:2002
  Instructions for use for in vitro diagnostic instruments for self-testing | — | |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | EN 980:2003 | 31.5.2010 |
| CEN | EN 12286:1998

  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures | — | |
| EN 12286:1998/A1:2000 | Note 3 | Date expired
  (24.11.2000) |
| CEN | EN 12287:1999

  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials | — | |
| CEN | EN 12322:1999

  In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media | — | |
| EN 12322:1999/A1:2001 | Note 3 | Date expired
  (30.4.2002) |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2009 |
| EN ISO 13485:2003/AC:2007 | | |
| CEN | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing | — | |
| CEN | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices | — | |
| CEN | EN 13640:2002
  Stability testing of in vitro diagnostic reagents | — | |
| CEN | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents | — | |
| CEN | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects | — | |
| CEN | EN 14136:2004
  Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures | — | |
| CEN | EN 14254:2004

  In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans | — | |
| CEN | EN 14820:2004
  Single-use containers for human venous blood specimen collection | — | |
| CEN | EN ISO 14937:2000
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) | — | |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | EN ISO 14971:2000 | 31.3.2010 |
| CEN | EN ISO 15197:2003

  In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | — | |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | — | |
| CEN | EN ISO 17511:2003

  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 18153:2003

  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) | — | |
| CEN | EN ISO 20776-1:2006
  Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) | — | |

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

(Note 1)

CEN

EN 375:2001

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

—

CEN

EN 376:2002

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

—

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

—

CEN

EN 591:2001

Instructions for use for in vitro diagnostic instruments for professional use

—

CEN

EN 592:2002

Instructions for use for in vitro diagnostic instruments for self-testing

—

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

CEN

EN 12286:1998

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures

—

EN 12286:1998/A1:2000

Note 3

Date expired

(24.11.2000)

CEN

EN 12287:1999

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

—

CEN

EN 12322:1999

In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media

—

EN 12322:1999/A1:2001

Note 3

Date expired

(30.4.2002)

CEN

EN ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2009

EN ISO 13485:2003/AC:2007

CEN

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

—

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

—

CEN

EN 13640:2002

Stability testing of in vitro diagnostic reagents

—

CEN

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

—

CEN

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects

—

CEN

EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

—

CEN

EN 14254:2004

In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans

—

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

—

CEN

EN ISO 14937:2000

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

—

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

CEN

EN ISO 15197:2003

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

—

CEN

EN ISO 15225:2000

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

—

CEN

EN ISO 17511:2003

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 18153:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

—

CEN

EN ISO 20776-1:2006

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential 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 of the Council (2) amended by the Directive 98/48/EC (3), |
| --- | --- |

—

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 of the Council (2) amended by the Directive 98/48/EC (3),

| — | 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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu), |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu),

| — | Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org), |
| --- | --- |

—

Cenelec: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org),

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org).

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/30 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/30

---

Call for proposals under the annual work programme for grants in the field of the Trans-European Energy Network (TEN-E) for 2009

(Commission Decision C(2009) 1360)

(2009/C 41/08)

The European Commission, Directorate-General for Energy and Transport, is hereby launching a call for proposals in order to award grants to projects in accordance with the priorities and objectives defined in the draft annual work programme for grants in the field of the Trans-European Energy Network for 2009.

The maximum amount available under this call for proposals, for 2009, is EUR 26 048 000.

The call is closing on 24 April 2009.

The complete text of the call for proposals is available on:

http://ec.europa.eu/energy/infrastructure/grants/index_en.htm

---

COURT PROCEEDINGS

EFTA Court

| 19.2.2009 | EN | Official Journal of the European Union | C 41/31 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/31

---

Action brought on 3 February 2009 by the EFTA Surveillance Authority against the Principality of Liechtenstein

(Case E-1/09)

(2009/C 41/09)

An action against the Principality of Liechtenstein was brought before the EFTA Court on 3 February 2009 by the EFTA Surveillance Authority, represented by Bjørnar Alterskjær and Florence Simonetti, acting as Agents of the EFTA Surveillance Authority, rue Belliard 35, B-1040 Brussels.

The EFTA Surveillance Authority requests the EFTA Court to declare that:

| 1. | by requiring the members of the management board and of the executive management of banks established in Liechtenstein to be, by reason of their residence, in a position to actually and flawlessly perform their functions and duties, the Principality of Liechtenstein has failed to fulfil its obligations under the EEA Agreement, in particular Articles 28 and 31 thereof; |
| --- | --- |

1.

by requiring the members of the management board and of the executive management of banks established in Liechtenstein to be, by reason of their residence, in a position to actually and flawlessly perform their functions and duties, the Principality of Liechtenstein has failed to fulfil its obligations under the EEA Agreement, in particular Articles 28 and 31 thereof;

| 2. | by requiring a residence, wherefrom he is able to fulfil his tasks effectively and on a regular basis, for lawyers, patent lawyers, auditors and trustees the Principality of Liechtenstein has failed to fulfil its obligations under the EEA Agreement, in particular Article 31 thereof; |
| --- | --- |

2.

by requiring a residence, wherefrom he is able to fulfil his tasks effectively and on a regular basis, for lawyers, patent lawyers, auditors and trustees the Principality of Liechtenstein has failed to fulfil its obligations under the EEA Agreement, in particular Article 31 thereof;

| 3. | the Principality of Liechtenstein bear the costs of these proceedings. |
| --- | --- |

3.

the Principality of Liechtenstein bear the costs of these proceedings.

Legal and factual background and pleas in law adduced in support:

| — | the case concerns residence requirements under Liechtenstein law for members of the management board and of the executive management of banks established in Liechtenstein, and for lawyers, patent lawyers, auditors and trustees, |
| --- | --- |

—

the case concerns residence requirements under Liechtenstein law for members of the management board and of the executive management of banks established in Liechtenstein, and for lawyers, patent lawyers, auditors and trustees,

| — | Article 28 EEA secures freedom of movement for EEA nationals and abolishes discrimination based on nationality within EEA as regards inter alia employment, |
| --- | --- |

—

Article 28 EEA secures freedom of movement for EEA nationals and abolishes discrimination based on nationality within EEA as regards inter alia employment,

| — | Article 31 EEA requires equal treatment between EEA nationals invoking their right to freedom of establishment and those nationals of the country where the establishment is effected. |
| --- | --- |

—

Article 31 EEA requires equal treatment between EEA nationals invoking their right to freedom of establishment and those nationals of the country where the establishment is effected.

---

| 19.2.2009 | EN | Official Journal of the European Union | C 41/32 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/32

---

Action brought on 6 February 2009 by the EFTA Surveillance Authority against Iceland

(Case E-2/09)

(2009/C 41/10)

An action against Iceland was brought before the EFTA Court on 6 February 2009 by the EFTA Surveillance Authority, represented by Bjørnar Alterskjær and Ólafur Jóhannes Einarsson, acting as Agents of the EFTA Surveillance Authority, rue Belliard 35, B-1040 Brussels.

The EFTA Surveillance Authority requests the EFTA Court to declare that:

| 1. | by failing to adopt the measures necessary to make the Act referred to at point 66s of Chapter VI of Annex XIII to the Agreement on the European Economic Area (Commission Regulation (EC) No 593/2007 of 31 May 2007 on the fees and charges levied by the European Aviation Safety Agency), as adapted to the EEA Agreement by Protocol 1 thereto, part of its internal legal order within the time prescribed, the Republic of Iceland has failed to fulfil its obligations under Article 7 EEA;

  and |
| --- | --- |

1.

by failing to adopt the measures necessary to make the Act referred to at point 66s of Chapter VI of Annex XIII to the Agreement on the European Economic Area (Commission Regulation (EC) No 593/2007 of 31 May 2007 on the fees and charges levied by the European Aviation Safety Agency), as adapted to the EEA Agreement by Protocol 1 thereto, part of its internal legal order within the time prescribed, the Republic of Iceland has failed to fulfil its obligations under Article 7 EEA;

| 2. | the Republic of Iceland be ordered to bear the costs of these proceedings. |
| --- | --- |

2.

the Republic of Iceland be ordered to bear the costs of these proceedings.

Legal and factual background and pleas in law adduced in support:

| — | the present case concerns an EC regulation on the fees and charges levied by the European Aviation Safety Agency, |
| --- | --- |

—

the present case concerns an EC regulation on the fees and charges levied by the European Aviation Safety Agency,

| — | Article 7 of the EEA Agreement states that:

  ‘Acts referred to or contained in the Annexes to the Agreement or in decisions of the EEA Joint Committee shall be binding upon the Contracting Parties and be, or be made, part of their internal legal order as follows:







  (a) | an act corresponding to an EEC regulation shall as such be made part of the internal legal order of the Contracting Parties; |
| --- | --- | --- |

—

Article 7 of the EEA Agreement states that:

‘Acts referred to or contained in the Annexes to the Agreement or in decisions of the EEA Joint Committee shall be binding upon the Contracting Parties and be, or be made, part of their internal legal order as follows:

(a)

an act corresponding to an EEC regulation shall as such be made part of the internal legal order of the Contracting Parties;

| (b) | an act corresponding to an EEC directive shall leave to the authorities of the Contracting Parties the choice of form and method of implementation.’, |
| --- | --- |

(b)

an act corresponding to an EEC directive shall leave to the authorities of the Contracting Parties the choice of form and method of implementation.’,

| — | the EFTA Surveillance Authority pleads that the Government of Iceland has failed to make the regulation part of its internal legal order within the time prescribed. |
| --- | --- |

—

the EFTA Surveillance Authority pleads that the Government of Iceland has failed to make the regulation part of its internal legal order within the time prescribed.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/33 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/33

---

Prior notification of a concentration

(Case COMP/M.5456 — AIP/BBEIF/BBI Europe/Euroports)

Candidate case for simplified procedure

(Text with EEA relevance)

(2009/C 41/11)

| 1. | On 12 February 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings by which the undertakings Antin Infrastructure Partners FCPR (‘Antin IP’, France), an investment fund sponsored by BNP Paribas SA (‘BNP’, France), BBEIF LH Sub 06 S.à.r.l. (‘BBEIF 6’, Luxembourg), and BBI Europe Holdings (Malta II) Limited (‘BBI Europe’, Luxembourg), both belonging to Babcock & Brown Limited (‘B&B’, Australia) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking BBI Europe Holdings (Lux) S.à.r.l. (‘Euroports’, Luxembourg), currently controlled by BBI Europe by way of purchase of shares. |
| --- | --- |

1.

On 12 February 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings by which the undertakings Antin Infrastructure Partners FCPR (‘Antin IP’, France), an investment fund sponsored by BNP Paribas SA (‘BNP’, France), BBEIF LH Sub 06 S.à.r.l. (‘BBEIF 6’, Luxembourg), and BBI Europe Holdings (Malta II) Limited (‘BBI Europe’, Luxembourg), both belonging to Babcock & Brown Limited (‘B&B’, Australia) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking BBI Europe Holdings (Lux) S.à.r.l. (‘Euroports’, Luxembourg), currently controlled by BBI Europe by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | for Antin IP: investment into the energy, environment, transport, telecommunications and social sectors, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Antin IP: investment into the energy, environment, transport, telecommunications and social sectors,

| — | for BBEIF 6 and BBI Europe: investment into infrastructure assets, |
| --- | --- |

—

for BBEIF 6 and BBI Europe: investment into infrastructure assets,

| — | for Euroports: operation of ports, cargo handling and related services. |
| --- | --- |

—

for Euroports: operation of ports, cargo handling and related services.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5456 — AIP/BBEIF/BBI Europe/Euroports, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5456 — AIP/BBEIF/BBI Europe/Euroports, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Brussels

---

(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

---

| 19.2.2009 | EN | Official Journal of the European Union | C 41/34 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/34

---

Prior notification of a concentration

(Case COMP/M.5427 — Dexia Crédit Local/Dexia Kommunalkredit Bank)

Candidate case for simplified procedure

(Text with EEA relevance)

(2009/C 41/12)

| 1. | On 12 February 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Dexia Crédit Local (‘Dexia CL’, France), belonging to Dexia Group (Belgium), acquires within the meaning of Article 3(1)(b) of the Council Regulation sole control of Dexia Kommunalkredit Bank AG (‘Dexia-Komm’, Austria), which was jointly controlled by Dexia CL and Kommunalkredit Austria AG, by way of purchase of shares. |
| --- | --- |

1.

On 12 February 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Dexia Crédit Local (‘Dexia CL’, France), belonging to Dexia Group (Belgium), acquires within the meaning of Article 3(1)(b) of the Council Regulation sole control of Dexia Kommunalkredit Bank AG (‘Dexia-Komm’, Austria), which was jointly controlled by Dexia CL and Kommunalkredit Austria AG, by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | for Dexia CL: public finance services, mainly in France, Germany, Italy, Spain, Ireland, United Kingdom, Japan, Sweden and the United States, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Dexia CL: public finance services, mainly in France, Germany, Italy, Spain, Ireland, United Kingdom, Japan, Sweden and the United States,

| — | for Dexia Komm: public finance services, mainly in Central and Eastern Europe, |
| --- | --- |

—

for Dexia Komm: public finance services, mainly in Central and Eastern Europe,

| — | for Dexia Group: financial services worldwide. |
| --- | --- |

—

for Dexia Group: financial services worldwide.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2), it should be noted that this case is a candidate for treatment under the procedure set out in the said Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2), it should be noted that this case is a candidate for treatment under the procedure set out in the said Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5427 — Dexia Crédit Local/Dexia Kommunalkredit Bank, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5427 — Dexia Crédit Local/Dexia Kommunalkredit Bank, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Brussels

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(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

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OTHER ACTS

Commission

| 19.2.2009 | EN | Official Journal of the European Union | C 41/35 |
| --- | --- | --- | --- |

19.2.2009

EN

Official Journal of the European Union

C 41/35

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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

(2009/C 41/13)

This publication confers the right to object to the application pursuant to Article 7 of Regulation (EC) No 510/2006 (1). Statements of objection must reach the Commission within six months of the date of this publication.

SUMMARY

COUNCIL REGULATION (EC) No 510/2006

‘SCHWÄBISCHE MAULTASCHEN’/‘SCHWÄBISCHE SUPPENMAULTASCHEN’

EC No: DE-PGI-0005-0521-18.01.2006

PDO ( ) PGI (X)

This summary sets out the main elements of the product specification for information purposes.

1.   Responsible department in the Member State:

| Name: | Bundesministerium der Justiz |
| --- | --- |
| Address: | Mohrenstraße 37 |
| D-10117 Berlin |

Name:

Bundesministerium der Justiz

Address:

Mohrenstraße 37

D-10117 Berlin

Tel.

+49(0)30/2025-70

Fax

+49(0)30/2025-82 51

E-mail:

—

2.   Group:

| Name: | Schutzgemeinschaft 'Schwäbische Maultaschen' c/o Bürger GmbH z.H. Herrn Martin Bihlmaier |
| --- | --- |
| Address: | Zeiss-Straße 12 |
| D-71254 Ditzingen |

Name:

Schutzgemeinschaft 'Schwäbische Maultaschen' c/o Bürger GmbH z.H. Herrn Martin Bihlmaier

Address:

Zeiss-Straße 12

D-71254 Ditzingen

Tel.

+49(0)7156/30022083

Fax

+49(0)7156/3002942083

E-mail:

martin.bihlmaier@buerger.de

Composition:

Producers/processors ( X ) Other ( )

3.   Nature of the product:

Class 2.7: Pasta

4.   Specification:

(Summary of requirements under Article 4(2) of Regulation (EC) No 510/2006)

4.1.   Name:

‘Schwäbische Maultaschen’/‘Schwäbische Suppenmaultaschen’

4.2.   Description:

Stuffed pasta pouches filled with minced meat or vegetables.

Square or rounded pasta pouches; fresh or packed; boiled or fried prior to eating.

Composition

Durum wheat flour and/or ordinary flour, whole egg, water and salt for the dough. Pork, beef, in some cases smoked pork belly, spinach, parsley, onions, eggs, spices, bread and leek for the filling. The ingredients and their relative proportions vary depending on the recipe and regional version, within the limits of the quality criteria set out below.

Quality criteria

| Quality characteristics | Minimum requirements |
| --- | --- |
| Colour/appearance | Dough casing pale yellow to pale grey, filling loosely mixed with structure still recognisable |
| Shape | Square or rounded |
| Size |
| Standard Maultasche | Length 5,5 to 10, width 5 to 9, height 1,5 to 2,5 cm |
| Suppenmaultasche | Length 1 to 5,5, width 1 to 5, height 0,5 to 2 cm |
| Consistency/texture | Dough casing firm to the bite and not sticky; filling soft, emulsion still intact |
| Weight |
| Standard Maultasche | 40 to 150 g |
| Suppenmaultasche | 10 to 40 g |
| Protein content of Maultaschen and Suppenmaultaschen containing meat | Minced meat: fibrous protein-free meat protein at least 7 % |
| Fresh eggs | Whole grade A eggs; dry matter content at least 23 % |
| Meat content | At least 8 % of total weight |

Quality characteristics

Minimum requirements

Colour/appearance

Dough casing pale yellow to pale grey, filling loosely mixed with structure still recognisable

Shape

Square or rounded

Size

Standard Maultasche

Length 5,5 to 10, width 5 to 9, height 1,5 to 2,5 cm

Suppenmaultasche

Length 1 to 5,5, width 1 to 5, height 0,5 to 2 cm

Consistency/texture

Dough casing firm to the bite and not sticky; filling soft, emulsion still intact

Weight

Standard Maultasche

40 to 150 g

Suppenmaultasche

10 to 40 g

Protein content of Maultaschen and Suppenmaultaschen containing meat

Minced meat: fibrous protein-free meat protein at least 7 %

Fresh eggs

Whole grade A eggs; dry matter content at least 23 %

Meat content

At least 8 % of total weight

4.3.   Geographical area:

The geographical area of Swabia comprises all of Baden-Württemberg and all of the region of Swabia in Bavaria.

4.4.   Proof of origin:

Traceability throughout the value-added chain is ensured by the IFS (International Food Safety) standard. The firms involved have undertaken to comply with this standard. The sales packaging must ensure unbroken traceability back to the raw material stage and as regards the customers to which a particular batch was supplied (down to individual pack level).

4.5.   Method of production:

Flour, durum wheat flour, eggs and water are mixed and kneaded to a dough. The dough is extruded or rolled into a thin sheet. The filling (minced meat or vegetables) is then made and mixed with bread, spinach, onions and spices. The filling portions are then measured out onto the dough. The dough is wrapped over and cut into individual Maultaschen portions, heated, then cooled to 2 to 7 °C. Goods to be marketed deep-frozen are frozen to – 18 °C.

Conservation; storage

Maultaschen are marketed fresh or packed.

4.6.   Link to geographical area:

‘Schwäbische Maultaschen’ are a Swabian speciality with a centuries-old tradition held in high esteem by consumers. No other Swabian dish is as popular and as well-known as a speciality way beyond the borders of Swabia (Baden-Württemberg and the region of Swabia in Bavaria). ‘Schwäbische Maultaschen’ are frequently referred to alongside Swabia's famous people and significant inventions. In addition to being the traditional Lenten fare eaten on Maundy Thursday, in Swabia Maultaschen have now become a highly popular all-year-round dish. Maultaschen are mentioned in Swabian literature and associated with a large number of festivals and customs in Swabia.

Every autumn the traditional ‘Maultaschen festival’ is held in Freiberg am Neckar. The municipality of Baiersbronn even elects a ‘Maultaschen queen’. Maultaschen also play a role in tourism. For example, in the historic town of Bad Urach, which was formerly the seat of the ruling counts, there is a Maultaschen trail providing information on the Swabian Alb and its scenery and culinary specialities.

Maultaschen are now made and sold in Swabia by almost all butcher's shops, meat product manufacturers and local restaurants.

The Swabia region holds several Maultaschen world records: in 1982 a publican in Maulbronn in Swabia made 1 134 Maultaschen in 22 minutes and thus broke the record set the previous year by a master butcher in Stuttgart-Untertürkheim. In 1987, the same publican entered the Guinness Book of Records with a giant Maultasche. Ten years later, in 1997, chefs from Freiberg am Neckar set a new record. Shortly after, in 2000, that record was broken by chefs from Baiersbronn.

Swabian literature is littered with poems and stories about Maultaschen. With tongue in cheek, the Swabian author Thaddäus Troll even once likened the Swabian identity to a Maultasche.

The Swabian dialect poet Heinz Eugen Schramm wrote a poem about making Maultaschen.

The Swabian dialect poet Friedrich E. Vogt also gave Maultaschen their place in literature as a standard feature on the Swabian menu.

4.7.   Inspection body:

| Name: | LACON GmbH |
| --- | --- |
| Address: | Brünnlesweg 19 |
| D-77654 Offenburg |

Name:

LACON GmbH

Address:

Brünnlesweg 19

D-77654 Offenburg

Tel.

0781 919 37 30

Fax

0781 919 37 50

E-mail:

lacon@lacon-institut.com, www.lacon-institut.com

4.8.   Labelling:

Schwäbische Maultaschen g.g.A.

Schwäbische Suppenmaultaschen g.g.A

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(1)  OJ L 93, 31.3.2006, p. 12.

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