# Official Journal C 304/2008

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 304 |
| | |
| English edition | Information and Notices | Volume 5127 November 2008 |

ISSN 1725-2423

Official Journal

of the European Union

C 304

English edition

Information and Notices

Volume 5127 November 2008

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 304/01 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections | 1 |
| 2008/C 304/02 | Non-opposition to a notified concentration (Case COMP/M.5307 — Accueil Partenaires/CDC/RHVS 1% Logement/SGRHVS) (
  1
  ) | 3 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 304/01

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections

1

2008/C 304/02

Non-opposition to a notified concentration (Case COMP/M.5307 — Accueil Partenaires/CDC/RHVS 1% Logement/SGRHVS) (
  1
  )

1

3

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 304/03 | Euro exchange rates | 4 |
| | NOTICES FROM MEMBER STATES |
| 2008/C 304/04 | 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
  ) | 5 |
| 2008/C 304/05 | 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
  ) | 7 |
| 2008/C 304/06 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (
  1
  ) | 8 |
| 2008/C 304/07 | Extract from the Decision concerning Kaupthing Bank Luxembourg SA pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions | 17 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 304/03

Euro exchange rates

4

NOTICES FROM MEMBER STATES

2008/C 304/04

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

5

2008/C 304/05

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

7

2008/C 304/06

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

1

8

2008/C 304/07

Extract from the Decision concerning Kaupthing Bank Luxembourg SA pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

17

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY |
| | Commission |
| 2008/C 304/08 | Notice concerning the anti-dumping measures in force in respect of imports into the Community of cotton-type bed linen originating in Pakistan: change of the address of a company subject to an individual anti-dumping duty | 18 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2008/C 304/09 | Prior notification of a concentration (Case COMP/M.5396 — En+/Russneft) — Candidate case for simplified procedure (
  1
  ) | 19 |
| 2008/C 304/10 | Prior notification of a concentration (Case COMP/M.5401 — REWE/Coop Switzerland/transGourmet Holding SE) — Candidate case for simplified procedure (
  1
  ) | 20 |
| 2008/C 304/11 | Prior notification of a concentration (Case COMP/M.5405 — Hargreaves/Evonik/JV) — Candidate case for simplified procedure (
  1
  ) | 21 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

2008/C 304/08

Notice concerning the anti-dumping measures in force in respect of imports into the Community of cotton-type bed linen originating in Pakistan: change of the address of a company subject to an individual anti-dumping duty

18

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2008/C 304/09

Prior notification of a concentration (Case COMP/M.5396 — En+/Russneft) — Candidate case for simplified procedure (
  1
  )

1

19

2008/C 304/10

Prior notification of a concentration (Case COMP/M.5401 — REWE/Coop Switzerland/transGourmet Holding SE) — Candidate case for simplified procedure (
  1
  )

1

20

2008/C 304/11

Prior notification of a concentration (Case COMP/M.5405 — Hargreaves/Evonik/JV) — Candidate case for simplified procedure (
  1
  )

1

21

| | |
| --- | --- |
| 2008/C 304/12 | Note to the reader(see page 3 of the cover) | s3 |

2008/C 304/12

Note to the reader(see page 3 of the cover)

Note to the reader

s3

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.11.2008 | EN | Official Journal of the European Union | C 304/1 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/1

---

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2008/C 304/01)

| Date of adoption of the decision | 28.10.2008 |
| --- | --- |
| Reference number of the aid | N 771/07 |
| Member State | Belgium |
| Region | Walloon region |
| Title | «Mesure agro-environnementale: Plan de gestion environnementale» |
| Legal basis | Arrêté du gouvernement wallon du 24 avril 2008 relatif à l'octroi de subventions agro-environnementales |
| Type of measure | Aid scheme |
| Objective | Heritage conservation |
| Form of aid | Grant |
| Budget | EUR 1 230 000 |
| Intensity | Up to 100 % |
| Duration | 2008-2013 |
| Economic sectors | Agricultural sector |
| Name and address of the granting authority | Région wallonne |
| Direction Générale de l'Agriculture |
| Chaussée de Louvain, 14 |
| B-5000 Namur |

Date of adoption of the decision

28.10.2008

Reference number of the aid

N 771/07

Member State

Belgium

Region

Walloon region

Title

«Mesure agro-environnementale: Plan de gestion environnementale»

Legal basis

Arrêté du gouvernement wallon du 24 avril 2008 relatif à l'octroi de subventions agro-environnementales

Type of measure

Aid scheme

Objective

Heritage conservation

Form of aid

Grant

Budget

EUR 1 230 000

Intensity

Up to 100 %

Duration

2008-2013

Economic sectors

Agricultural sector

Name and address of the granting authority

Région wallonne

Direction Générale de l'Agriculture

Chaussée de Louvain, 14

B-5000 Namur

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

| Date of adoption of the decision | 8.9.2008 |
| --- | --- |
| Reference number of the aid | N 107/08 |
| Member State | France |
| Region | Saône-et-Loire |
| Title (and/or name of the beneficiary) | Aides aux investissements pour la protection sanitaire des élevages de volailles de Bresse |
| Legal basis | Articles L 1511-1 à 1511-6 du Code général des collectivités territoriales et L 3231-2 et suivants. Arrêté du ministre de l’agriculture et de la pêche du 5 février 2007 |
| Type of measure | Aid scheme |
| Objective | Investment for animal health protection in animal husbandry, in particular against the risk of avian influenza |
| Form of aid | Direct grant |
| Budget | EUR 360 000 |
| Intensity | Maximum 40 % |
| Duration | 2 years |
| Economic sectors | Agriculture |
| Name and address of the granting authority | Conseil général de Saône-et-Loire |
| Espace Duhesme |
| 18, rue de Flacé |
| F-71026 Macon Cedex 9 |

Date of adoption of the decision

8.9.2008

Reference number of the aid

N 107/08

Member State

France

Region

Saône-et-Loire

Title (and/or name of the beneficiary)

Aides aux investissements pour la protection sanitaire des élevages de volailles de Bresse

Legal basis

Articles L 1511-1 à 1511-6 du Code général des collectivités territoriales et L 3231-2 et suivants. Arrêté du ministre de l’agriculture et de la pêche du 5 février 2007

Type of measure

Aid scheme

Objective

Investment for animal health protection in animal husbandry, in particular against the risk of avian influenza

Form of aid

Direct grant

Budget

EUR 360 000

Intensity

Maximum 40 %

Duration

2 years

Economic sectors

Agriculture

Name and address of the granting authority

Conseil général de Saône-et-Loire

Espace Duhesme

18, rue de Flacé

F-71026 Macon Cedex 9

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

---

| 27.11.2008 | EN | Official Journal of the European Union | C 304/3 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/3

---

Non-opposition to a notified concentration

(Case COMP/M.5307 — Accueil Partenaires/CDC/RHVS 1% Logement/SGRHVS)

(Text with EEA relevance)

(2008/C 304/02)

On 13 November 2008, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in French and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website under document number 32008M5307. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32008M5307. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.11.2008 | EN | Official Journal of the European Union | C 304/4 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/4

---

Euro exchange rates (1)

26 November 2008

(2008/C 304/03)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2935 |
| JPY | Japanese yen | 123,10 |
| DKK | Danish krone | 7,4534 |
| GBP | Pound sterling | 0,84560 |
| SEK | Swedish krona | 10,3173 |
| CHF | Swiss franc | 1,5456 |
| ISK | Iceland króna | 275,00 |
| NOK | Norwegian krone | 9,0340 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,080 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 260,08 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7093 |
| PLN | Polish zloty | 3,7675 |
| RON | Romanian leu | 3,8385 |
| SKK | Slovak koruna | 30,355 |
| TRY | Turkish lira | 2,0665 |
| AUD | Australian dollar | 1,9992 |
| CAD | Canadian dollar | 1,5985 |
| HKD | Hong Kong dollar | 10,0322 |
| NZD | New Zealand dollar | 2,3578 |
| SGD | Singapore dollar | 1,9556 |
| KRW | South Korean won | 1 900,54 |
| ZAR | South African rand | 12,9283 |
| CNY | Chinese yuan renminbi | 8,8329 |
| HRK | Croatian kuna | 7,1400 |
| IDR | Indonesian rupiah | 15 974,73 |
| MYR | Malaysian ringgit | 4,6857 |
| PHP | Philippine peso | 63,540 |
| RUB | Russian rouble | 35,4275 |
| THB | Thai baht | 45,599 |
| BRL | Brazilian real | 3,0393 |
| MXN | Mexican peso | 17,2941 |

Currency

Exchange rate

USD

US dollar

1,2935

JPY

Japanese yen

123,10

DKK

Danish krone

7,4534

GBP

Pound sterling

0,84560

SEK

Swedish krona

10,3173

CHF

Swiss franc

1,5456

ISK

Iceland króna

275,00

NOK

Norwegian krone

9,0340

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,080

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

260,08

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7093

PLN

Polish zloty

3,7675

RON

Romanian leu

3,8385

SKK

Slovak koruna

30,355

TRY

Turkish lira

2,0665

AUD

Australian dollar

1,9992

CAD

Canadian dollar

1,5985

HKD

Hong Kong dollar

10,0322

NZD

New Zealand dollar

2,3578

SGD

Singapore dollar

1,9556

KRW

South Korean won

1 900,54

ZAR

South African rand

12,9283

CNY

Chinese yuan renminbi

8,8329

HRK

Croatian kuna

7,1400

IDR

Indonesian rupiah

15 974,73

MYR

Malaysian ringgit

4,6857

PHP

Philippine peso

63,540

RUB

Russian rouble

35,4275

THB

Thai baht

45,599

BRL

Brazilian real

3,0393

MXN

Mexican peso

17,2941

---

(1)

Source: reference exchange rate published by the ECB.

---

NOTICES FROM MEMBER STATES

| 27.11.2008 | EN | Official Journal of the European Union | C 304/5 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/5

---

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 harmonized standards under the directive)

(2008/C 304/04)

| ESO (1) | Reference and title of the standard
  (and reference document) | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| Cenelec | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | — | — |
| Cenelec | EN 45502-2-1:2003
  Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | — | — |
| Cenelec | EN 45502-2-2:2008
  Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | — | — |
| Cenelec | EN 60601-1:1990
  Medical electrical equipment — Part 1: General requirements for safety
  (IEC 60601-1:1988) | — | — |
| Amendment A1:1993 to EN 60601-1:1990
  (IEC 60601-1:1988/A1:1991) | Note 3 | — |
| Amendment A2:1995 to EN 60601-1:1990
  (IEC 60601-1:1988/A2:1995) | Note 3 | — |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  (IEC 60601-1:2005) | EN 60601-1:1990
  and its amendments
  Note 2.1 | — |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  (IEC 62304:2006) | — | — |

ESO (1)

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

(Note 1)

Cenelec

EN 45502-1:1997

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

—

—

Cenelec

EN 45502-2-1:2003

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

—

—

Cenelec

EN 45502-2-2:2008

Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

—

—

Cenelec

EN 60601-1:1990

Medical electrical equipment — Part 1: General requirements for safety

(IEC 60601-1:1988)

—

—

Amendment A1:1993 to EN 60601-1:1990

(IEC 60601-1:1988/A1:1991)

Note 3

—

Amendment A2:1995 to EN 60601-1:1990

(IEC 60601-1:1988/A2:1995)

Note 3

—

Cenelec

EN 60601-1:2006

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

(IEC 60601-1:2005)

EN 60601-1:1990

and its amendments

Note 2.1

—

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

(IEC 62304:2006)

—

—

| 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 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. 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 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.

---

(1)  ESO: European Standarisation Organisation:

| — | CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be), |
| --- | --- |

—

CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be),

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

—

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

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org).

---

| 27.11.2008 | EN | Official Journal of the European Union | C 304/7 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/7

---

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 harmonized standards under the directive)

(2008/C 304/05)

| ESO  (1) | Reference and title of the standard
  (and reference document) | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| Cenelec | EN 61010-2-101:2002
  Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
  (IEC 61010-2-101:2002 (Modified)) | — | — |
| Cenelec | EN 61326-2-6:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment
  (IEC 61326-2-6:2005) | — | — |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  (IEC 62304:2006) | — | — |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  (IEC 62366:2007) | — | — |

ESO  (1)

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

(Note 1)

Cenelec

EN 61010-2-101:2002

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

(IEC 61010-2-101:2002 (Modified))

—

—

Cenelec

EN 61326-2-6:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment

(IEC 61326-2-6:2005)

—

—

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

(IEC 62304:2006)

—

—

Cenelec

EN 62366:2008

Medical devices — Application of usability engineering to medical devices

(IEC 62366:2007)

—

—

| 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.

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be), |
| --- | --- |

—

CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be),

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

—

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

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org).

---

| 27.11.2008 | EN | Official Journal of the European Union | C 304/8 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/8

---

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 harmonized standards under the directive)

(2008/C 304/06)

| ESO (1) | Reference and title of the standard
  (and reference document) | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  (Note 1) |
| --- | --- | --- | --- |
| Cenelec | EN 60118-13:2005
  Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)
  (IEC 60118-13:2004) | EN 60118-13:1997
  Note 2.1 | Date expired
  (1.2.2008) |
| Cenelec | EN 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies
  (IEC 60522:1999) | — | — |
| Cenelec | EN 60580:2000
  Medical electrical equipment — Dose area product meters
  (IEC 60580:2000) | — | — |
| Cenelec | EN 60601-1:1990
  Medical electrical equipment — Part 1: General requirements for safety
  (IEC 60601-1:1988) | — | — |
| Amendment A1:1993 to EN 60601-1:1990
  (IEC 60601-1:1988/A1:1991) | Note 3 | — |
| Amendment A2:1995 to EN 60601-1:1990
  (IEC 60601-1:1988/A2:1995) | Note 3 | — |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  (IEC 60601-1:2005) | EN 60601-1:1990
  and its amendments
  Note 2.1 | — |
| Cenelec | EN 60601-1-1:2001
  Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
  (IEC 60601-1-1:2000) | EN 60601-1-1:1993
  - A1:1996
  Note 2.1 | Date expired
  (1.12.2003) |
| Cenelec | EN 60601-1-2:2001
  Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
  (IEC 60601-1-2:2001) | EN 60601-1-2:1993
  Note 2.1 | Date expired
  (1.11.2004) |
| Amendment A1:2006 to EN 60601-1-2:2001
  (IEC 60601-1-2:2001/A1:2004) | — | 1.3.2009 |
| Cenelec | EN 60601-1-2:2007
  Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
  (IEC 60601-1-2:2007 (Modified)) | EN 60601-1-2:2001
  and its amendment
  Note 2.1 | — |
| Cenelec | EN 60601-1-3:1994
  Medical electrical equipment — Part 1: General requirements for safety — Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
  (IEC 60601-1-3:1994) | — | — |
| Cenelec | EN 60601-1-3:2008
  Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral standard: Radiation protection in diagnostic X-ray equipment
  (IEC 60601-1-3:2008) | EN 60601-1-3:1994
  Note 2.1 | — |
| Cenelec | EN 60601-1-4:1996
  Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems
  (IEC 60601-1-4:1996) | — | — |
| Amendment A1:1999 to EN 60601-1-4:1996
  (IEC 60601-1-4:1996/A1:1999) | Note 3 | Date expired
  (1.12.2002) |
| Cenelec | EN 60601-1-6:2004
  Medical electrical equipment — Part 1-6: General requirements for safety — Collateral standard: Usability
  (IEC 60601-1-6:2004) | — | — |
| Cenelec | EN 60601-1-6:2007
  Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
  (IEC 60601-1-6:2006) | EN 60601-1-6:2004
  Note 2.1 | — |
| Cenelec | EN 60601-1-8:2004
  Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  (IEC 60601-1-8:2003) | — | — |
| Amendment A1:2006 to EN 60601-1-8:2004
  (IEC 60601-1-8:2003/A1:2006) | Note 3 | Date expired
  (1.1.2007) |
| Cenelec | EN 60601-1-8:2007
  Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  (IEC 60601-1-8:2006) | EN 60601-1-8:2004
  and its amendment | — |
| Cenelec | EN 60601-1-10:2008
  Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers
  (IEC 60601-1-10:2007) | — | — |
| Cenelec | EN 60601-2-1:1998
  Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
  (IEC 60601-2-1:1998) | — | — |
| Amendment A1:2002 to EN 60601-2-1:1998
  (IEC 60601-2-1:1998/A1:2002) | Note 3 | Date expired
  (1.6.2005) |
| Cenelec | EN 60601-2-2:2000
  Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
  (IEC 60601-2-2:1998) | EN 60601-2-2:1993
  Note 2.1 | Date expired
  (1.8.2003) |
| Cenelec | EN 60601-2-2:2007
  Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
  (IEC 60601-2-2:2006) | EN 60601-2-2:2000
  Note 2.1 | 1.10.2009 |
| Cenelec | EN 60601-2-3:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment
  (IEC 60601-2-3:1991) | — | — |
| Amendment A1:1998 to EN 60601-2-3:1993
  (IEC 60601-2-3:1991/A1:1998) | Note 3 | Date expired
  (1.7.2001) |
| Cenelec | EN 60601-2-4:2003
  Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators
  (IEC 60601-2-4:2002) | — | — |
| Cenelec | EN 60601-2-5:2000
  Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
  (IEC 60601-2-5:2000) | — | — |
| Cenelec | EN 60601-2-7:1998
  Medical electrical equipment — Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
  (IEC 60601-2-7:1998) | — | — |
| Cenelec | EN 60601-2-8:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
  (IEC 60601-2-8:1987) | — | — |
| Amendment A1:1997 to EN 60601-2-8:1997
  (IEC 60601-2-8:1987/A1:1997) | Note 3 | Date expired
  (1.6.1998) |
| Cenelec | EN 60601-2-10:2000
  Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
  (IEC 60601-2-10:1987) | — | — |
| Amendment A1:2001 to EN 60601-2-10:2000
  (IEC 60601-2-10:1987/A1:2001) | Note 3 | Date expired
  (1.11.2004) |
| Cenelec | EN 60601-2-11:1997
  Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
  (IEC 60601-2-11:1997) | — | — |
| Amendment A1:2004 to EN 60601-2-11:1997
  (IEC 60601-2-11:1997/A1:2004) | Note 3 | Date expired
  (1.9.2007) |
| Cenelec | EN 60601-2-12:2006
  Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators
  (IEC 60601-2-12:2001) | — | — |
| Cenelec | EN 60601-2-13:2006
  Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
  (IEC 60601-2-13:2003) | —
  Note 2.3 | — |
| Amendment A1:2007 to EN 60601-2-13:2006
  (IEC 60601-2-13:2003/A1:2006) | Note 3 | 1.3.2010 |
| Cenelec | EN 60601-2-16:1998
  Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  (IEC 60601-2-16:1998) | — | — |
| Cenelec | EN 60601-2-17:2004
  Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
  (IEC 60601-2-17:2004) | EN 60601-2-17:1996
  - A1:1996
  Note 2.1 | Date expired
  (1.3.2007) |
| Cenelec | EN 60601-2-18:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment
  (IEC 60601-2-18:1996) | — | — |
| Amendment A1:2000 to EN 60601-2-18:1996
  (IEC 60601-2-18:1996/A1:2000) | Note 3 | Date expired
  (1.8.2003) |
| Cenelec | EN 60601-2-19:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators
  (IEC 60601-2-19:1990) | — | — |
| Amendment A1:1996 to EN 60601-2-19:1996
  (IEC 60601-2-19:1990/A1:1996) | Note 3 | Date expired
  (13.6.1998) |
| Cenelec | EN 60601-2-20:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of transport incubators
  (IEC 60601-2-20:1990
  - A1:1996) | — | — |
| Cenelec | EN 60601-2-21:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers
  (IEC 60601-2-21:1994) | — | — |
| Amendment A1:1996 to EN 60601-2-21:1994
  (IEC 60601-2-21:1994/A1:1996) | Note 3 | Date expired
  (13.6.1998) |
| Cenelec | EN 60601-2-22:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
  (IEC 60601-2-22:1995) | — | — |
| Cenelec | EN 60601-2-23:2000
  Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
  (IEC 60601-2-23:1999) | EN 60601-2-23:1997
  Note 2.1 | Date expired
  (1.1.2003) |
| Cenelec | EN 60601-2-24:1998
  Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers
  (IEC 60601-2-24:1998) | — | — |
| Cenelec | EN 60601-2-25:1995
  Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs
  (IEC 60601-2-25:1993) | — | — |
| Amendment A1:1999 to EN 60601-2-25:1995
  (IEC 60601-2-25:1993/A1:1999) | Note 3 | Date expired
  (1.5.2002) |
| Cenelec | EN 60601-2-26:2003
  Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs
  (IEC 60601-2-26:2002) | EN 60601-2-26:1994
  Note 2.1 | Date expired
  (1.3.2006) |
| Cenelec | EN 60601-2-27:2006
  Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
  (IEC 60601-2-27:2005) | EN 60601-2-27:1994
  Note 2.1 | Date expired
  (1.11.2008) |
| Cenelec | EN 60601-2-28:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
  (IEC 60601-2-28:1993) | — | — |
| Cenelec | EN 60601-2-29:1999
  Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators
  (IEC 60601-2-29:1999) | EN 60601-2-29:1995
  - A1:1996
  Note 2.1 | Date expired
  (1.4.2002) |
| Cenelec | EN 60601-2-30:2000
  Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
  (IEC 60601-2-30:1999) | EN 60601-2-30:1995
  Note 2.1 | Date expired
  (1.2.2003) |
| Cenelec | EN 60601-2-31:1995
  Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
  (IEC 60601-2-31:1994) | — | — |
| Amendment A1:1998 to EN 60601-2-31:1995
  (IEC 60601-2-31:1994/A1:1998) | Note 3 | Date expired
  (1.1.2001) |
| Cenelec | EN 60601-2-32:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
  (IEC 60601-2-32:1994) | — | — |
| Cenelec | EN 60601-2-33:2002
  Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  (IEC 60601-2-33:2002)
  - Corrigendum 11.2008 | EN 60601-2-33:1995
  - A11:1997
  Note 2.1 | Date expired
  (1.7.2005) |
| Amendment A1:2005 to EN 60601-2-33:2002
  (IEC 60601-2-33:2002/A1:2005) | Note 3 | Date expired
  (1.11.2008) |
| Amendment A2:2008 to EN 60601-2-33:2002
  (IEC 60601-2-33:2002/A2:2007) | Note 3 | 1.2.2011 |
| Cenelec | EN 60601-2-34:2000
  Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
  (IEC 60601-2-34:2000) | EN 60601-2-34:1995
  Note 2.1 | Date expired
  (1.11.2003) |
| Cenelec | EN 60601-2-35:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
  (IEC 60601-2-35:1996) | — | — |
| Cenelec | EN 60601-2-36:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  (IEC 60601-2-36:1997) | — | — |
| Cenelec | EN 60601-2-37:2001
  Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
  (IEC 60601-2-37:2001) | — | — |
| Amendment A1:2005 to EN 60601-2-37:2001
  (IEC 60601-2-37:2001/A1:2004) | Note 3 | Date expired
  (1.1.2008) |
| Amendment A2:2005 to EN 60601-2-37:2001
  (IEC 60601-2-37:2001/A2:2005) | Note 3 | 1.12.2008 |
| Cenelec | EN 60601-2-37:2008
  Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  (IEC 60601-2-37:2007) | EN 60601-2-37:2001
  and its amendments
  Note 2.1 | 1.10.2010 |
| Cenelec | EN 60601-2-38:1996
  Medical electrical equipment — Part 2-38: Particular requirements for the safety of electrically operated hospital beds
  (IEC 60601-2-38:1996) | — | — |
| Amendment A1:2000 to EN 60601-2-38:1996
  (IEC 60601-2-38:1996/A1:1999) | Note 3 | Date expired
  (1.1.2003) |
| Cenelec | EN 60601-2-39:1999
  Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
  (IEC 60601-2-39:1999) | — | — |
| Cenelec | EN 60601-2-39:2008
  Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
  (IEC 60601-2-39:2007) | EN 60601-2-39:1999
  Note 2.1 | 1.3.2011 |
| Cenelec | EN 60601-2-40:1998
  Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
  (IEC 60601-2-40:1998) | — | — |
| Cenelec | EN 60601-2-41:2000
  Medical electrical equipment — Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
  (IEC 60601-2-41:2000) | — | — |
| Cenelec | EN 60601-2-43:2000
  Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
  (IEC 60601-2-43:2000) | — | — |
| Cenelec | EN 60601-2-44:2001
  Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
  (IEC 60601-2-44:2001) | EN 60601-2-44:1999
  Note 2.1 | Date expired
  (1.7.2004) |
| Amendment A1:2003 to EN 60601-2-44:2001
  (IEC 60601-2-44:2001/A1:2002) | Note 3 | Date expired
  (1.12.2005) |
| Cenelec | EN 60601-2-45:2001
  Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
  (IEC 60601-2-45:2001) | EN 60601-2-45:1998
  Note 2.1 | Date expired
  (1.7.2004) |
| Cenelec | EN 60601-2-46:1998
  Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables
  (IEC 60601-2-46:1998) | — | — |
| Cenelec | EN 60601-2-47:2001
  Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  (IEC 60601-2-47:2001) | — | — |
| Cenelec | EN 60601-2-49:2001
  Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
  (IEC 60601-2-49:2001) | — | — |
| Cenelec | EN 60601-2-50:2002
  Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment
  (IEC 60601-2-50:2000) | — | — |
| Cenelec | EN 60601-2-51:2003
  Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
  (IEC 60601-2-51:2003) | — | — |
| Cenelec | EN 60627:2001
  Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids
  (IEC 60627:2001) | — | — |
| Cenelec | EN 60645-1:2001
  Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers
  (IEC 60645-1:2001) | EN 60645-1:1994
  Note 2.1 | Date expired
  (1.10.2004) |
| Cenelec | EN 60645-2:1997
  Audiometers — Part 2: Equipment for speech audiometry
  (IEC 60645-2:1993) | — | — |
| Cenelec | EN 60645-3:1995
  Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
  (IEC 60645-3:1994) | — | — |
| Cenelec | EN 60645-3:2007
  Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration
  (IEC 60645-3:2007) | EN 60645-3:1995
  Note 2.1 | 1.6.2010 |
| Cenelec | EN 60645-4:1995
  Audiometers — Part 4: Equipment for extended high-frequency audiometry
  (IEC 60645-4:1994) | — | — |
| Cenelec | EN 61217:1996
  Radiotherapy equipment — Coordinates, movements and scales
  (IEC 61217:1996) | — | — |
| Amendment A1:2001 to EN 61217:1996
  (IEC 61217:1996/A1:2000) | Note 3 | Date expired
  (1.12.2003) |
| Amendment A2:2008 to EN 61217:1996
  (IEC 61217:1996/A2:2007) | Note 3 | 1.2.2011 |
| Cenelec | EN 61676:2002
  Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
  (IEC 61676:2002) | — | — |
| Cenelec | EN 62083:2001
  Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
  (IEC 62083:2000) | — | — |
| Cenelec | EN 62220-1:2004
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency
  (IEC 62220-1:2003) | — | — |
| Cenelec | EN 62220-1-2:2007
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography
  (IEC 62220-1-2:2007) | — | — |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  (IEC 62304:2006) | — | — |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  (IEC 62366:2007) | — | — |

ESO (1)

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

(Note 1)

Cenelec

EN 60118-13:2005

Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)

(IEC 60118-13:2004)

EN 60118-13:1997

Note 2.1

Date expired

(1.2.2008)

Cenelec

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

(IEC 60522:1999)

—

—

Cenelec

EN 60580:2000

Medical electrical equipment — Dose area product meters

(IEC 60580:2000)

—

—

Cenelec

EN 60601-1:1990

Medical electrical equipment — Part 1: General requirements for safety

(IEC 60601-1:1988)

—

—

Amendment A1:1993 to EN 60601-1:1990

(IEC 60601-1:1988/A1:1991)

Note 3

—

Amendment A2:1995 to EN 60601-1:1990

(IEC 60601-1:1988/A2:1995)

Note 3

—

Cenelec

EN 60601-1:2006

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

(IEC 60601-1:2005)

EN 60601-1:1990

and its amendments

Note 2.1

—

Cenelec

EN 60601-1-1:2001

Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems

(IEC 60601-1-1:2000)

EN 60601-1-1:1993

- A1:1996

Note 2.1

Date expired

(1.12.2003)

Cenelec

EN 60601-1-2:2001

Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests

(IEC 60601-1-2:2001)

EN 60601-1-2:1993

Note 2.1

Date expired

(1.11.2004)

Amendment A1:2006 to EN 60601-1-2:2001

(IEC 60601-1-2:2001/A1:2004)

—

1.3.2009

Cenelec

EN 60601-1-2:2007

Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

(IEC 60601-1-2:2007 (Modified))

EN 60601-1-2:2001

and its amendment

Note 2.1

—

Cenelec

EN 60601-1-3:1994

Medical electrical equipment — Part 1: General requirements for safety — Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:1994)

—

—

Cenelec

EN 60601-1-3:2008

Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral standard: Radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:2008)

EN 60601-1-3:1994

Note 2.1

—

Cenelec

EN 60601-1-4:1996

Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems

(IEC 60601-1-4:1996)

—

—

Amendment A1:1999 to EN 60601-1-4:1996

(IEC 60601-1-4:1996/A1:1999)

Note 3

Date expired

(1.12.2002)

Cenelec

EN 60601-1-6:2004

Medical electrical equipment — Part 1-6: General requirements for safety — Collateral standard: Usability

(IEC 60601-1-6:2004)

—

—

Cenelec

EN 60601-1-6:2007

Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability

(IEC 60601-1-6:2006)

EN 60601-1-6:2004

Note 2.1

—

Cenelec

EN 60601-1-8:2004

Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

(IEC 60601-1-8:2003)

—

—

Amendment A1:2006 to EN 60601-1-8:2004

(IEC 60601-1-8:2003/A1:2006)

Note 3

Date expired

(1.1.2007)

Cenelec

EN 60601-1-8:2007

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

(IEC 60601-1-8:2006)

EN 60601-1-8:2004

and its amendment

—

Cenelec

EN 60601-1-10:2008

Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers

(IEC 60601-1-10:2007)

—

—

Cenelec

EN 60601-2-1:1998

Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

(IEC 60601-2-1:1998)

—

—

Amendment A1:2002 to EN 60601-2-1:1998

(IEC 60601-2-1:1998/A1:2002)

Note 3

Date expired

(1.6.2005)

Cenelec

EN 60601-2-2:2000

Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment

(IEC 60601-2-2:1998)

EN 60601-2-2:1993

Note 2.1

Date expired

(1.8.2003)

Cenelec

EN 60601-2-2:2007

Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment

(IEC 60601-2-2:2006)

EN 60601-2-2:2000

Note 2.1

1.10.2009

Cenelec

EN 60601-2-3:1993

Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment

(IEC 60601-2-3:1991)

—

—

Amendment A1:1998 to EN 60601-2-3:1993

(IEC 60601-2-3:1991/A1:1998)

Note 3

Date expired

(1.7.2001)

Cenelec

EN 60601-2-4:2003

Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators

(IEC 60601-2-4:2002)

—

—

Cenelec

EN 60601-2-5:2000

Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

(IEC 60601-2-5:2000)

—

—

Cenelec

EN 60601-2-7:1998

Medical electrical equipment — Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

(IEC 60601-2-7:1998)

—

—

Cenelec

EN 60601-2-8:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

(IEC 60601-2-8:1987)

—

—

Amendment A1:1997 to EN 60601-2-8:1997

(IEC 60601-2-8:1987/A1:1997)

Note 3

Date expired

(1.6.1998)

Cenelec

EN 60601-2-10:2000

Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

(IEC 60601-2-10:1987)

—

—

Amendment A1:2001 to EN 60601-2-10:2000

(IEC 60601-2-10:1987/A1:2001)

Note 3

Date expired

(1.11.2004)

Cenelec

EN 60601-2-11:1997

Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

(IEC 60601-2-11:1997)

—

—

Amendment A1:2004 to EN 60601-2-11:1997

(IEC 60601-2-11:1997/A1:2004)

Note 3

Date expired

(1.9.2007)

Cenelec

EN 60601-2-12:2006

Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators

(IEC 60601-2-12:2001)

—

—

Cenelec

EN 60601-2-13:2006

Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

(IEC 60601-2-13:2003)

—

Note 2.3

—

Amendment A1:2007 to EN 60601-2-13:2006

(IEC 60601-2-13:2003/A1:2006)

Note 3

1.3.2010

Cenelec

EN 60601-2-16:1998

Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

(IEC 60601-2-16:1998)

—

—

Cenelec

EN 60601-2-17:2004

Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

(IEC 60601-2-17:2004)

EN 60601-2-17:1996

- A1:1996

Note 2.1

Date expired

(1.3.2007)

Cenelec

EN 60601-2-18:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment

(IEC 60601-2-18:1996)

—

—

Amendment A1:2000 to EN 60601-2-18:1996

(IEC 60601-2-18:1996/A1:2000)

Note 3

Date expired

(1.8.2003)

Cenelec

EN 60601-2-19:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators

(IEC 60601-2-19:1990)

—

—

Amendment A1:1996 to EN 60601-2-19:1996

(IEC 60601-2-19:1990/A1:1996)

Note 3

Date expired

(13.6.1998)

Cenelec

EN 60601-2-20:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of transport incubators

(IEC 60601-2-20:1990

- A1:1996)

—

—

Cenelec

EN 60601-2-21:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers

(IEC 60601-2-21:1994)

—

—

Amendment A1:1996 to EN 60601-2-21:1994

(IEC 60601-2-21:1994/A1:1996)

Note 3

Date expired

(13.6.1998)

Cenelec

EN 60601-2-22:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

(IEC 60601-2-22:1995)

—

—

Cenelec

EN 60601-2-23:2000

Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

(IEC 60601-2-23:1999)

EN 60601-2-23:1997

Note 2.1

Date expired

(1.1.2003)

Cenelec

EN 60601-2-24:1998

Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers

(IEC 60601-2-24:1998)

—

—

Cenelec

EN 60601-2-25:1995

Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs

(IEC 60601-2-25:1993)

—

—

Amendment A1:1999 to EN 60601-2-25:1995

(IEC 60601-2-25:1993/A1:1999)

Note 3

Date expired

(1.5.2002)

Cenelec

EN 60601-2-26:2003

Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs

(IEC 60601-2-26:2002)

EN 60601-2-26:1994

Note 2.1

Date expired

(1.3.2006)

Cenelec

EN 60601-2-27:2006

Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

(IEC 60601-2-27:2005)

EN 60601-2-27:1994

Note 2.1

Date expired

(1.11.2008)

Cenelec

EN 60601-2-28:1993

Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

(IEC 60601-2-28:1993)

—

—

Cenelec

EN 60601-2-29:1999

Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators

(IEC 60601-2-29:1999)

EN 60601-2-29:1995

- A1:1996

Note 2.1

Date expired

(1.4.2002)

Cenelec

EN 60601-2-30:2000

Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

(IEC 60601-2-30:1999)

EN 60601-2-30:1995

Note 2.1

Date expired

(1.2.2003)

Cenelec

EN 60601-2-31:1995

Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

(IEC 60601-2-31:1994)

—

—

Amendment A1:1998 to EN 60601-2-31:1995

(IEC 60601-2-31:1994/A1:1998)

Note 3

Date expired

(1.1.2001)

Cenelec

EN 60601-2-32:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

(IEC 60601-2-32:1994)

—

—

Cenelec

EN 60601-2-33:2002

Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

(IEC 60601-2-33:2002)

- Corrigendum 11.2008

EN 60601-2-33:1995

- A11:1997

Note 2.1

Date expired

(1.7.2005)

Amendment A1:2005 to EN 60601-2-33:2002

(IEC 60601-2-33:2002/A1:2005)

Note 3

Date expired

(1.11.2008)

Amendment A2:2008 to EN 60601-2-33:2002

(IEC 60601-2-33:2002/A2:2007)

Note 3

1.2.2011

Cenelec

EN 60601-2-34:2000

Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

(IEC 60601-2-34:2000)

EN 60601-2-34:1995

Note 2.1

Date expired

(1.11.2003)

Cenelec

EN 60601-2-35:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

(IEC 60601-2-35:1996)

—

—

Cenelec

EN 60601-2-36:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

(IEC 60601-2-36:1997)

—

—

Cenelec

EN 60601-2-37:2001

Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

(IEC 60601-2-37:2001)

—

—

Amendment A1:2005 to EN 60601-2-37:2001

(IEC 60601-2-37:2001/A1:2004)

Note 3

Date expired

(1.1.2008)

Amendment A2:2005 to EN 60601-2-37:2001

(IEC 60601-2-37:2001/A2:2005)

Note 3

1.12.2008

Cenelec

EN 60601-2-37:2008

Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(IEC 60601-2-37:2007)

EN 60601-2-37:2001

and its amendments

Note 2.1

1.10.2010

Cenelec

EN 60601-2-38:1996

Medical electrical equipment — Part 2-38: Particular requirements for the safety of electrically operated hospital beds

(IEC 60601-2-38:1996)

—

—

Amendment A1:2000 to EN 60601-2-38:1996

(IEC 60601-2-38:1996/A1:1999)

Note 3

Date expired

(1.1.2003)

Cenelec

EN 60601-2-39:1999

Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

(IEC 60601-2-39:1999)

—

—

Cenelec

EN 60601-2-39:2008

Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

(IEC 60601-2-39:2007)

EN 60601-2-39:1999

Note 2.1

1.3.2011

Cenelec

EN 60601-2-40:1998

Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

(IEC 60601-2-40:1998)

—

—

Cenelec

EN 60601-2-41:2000

Medical electrical equipment — Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

(IEC 60601-2-41:2000)

—

—

Cenelec

EN 60601-2-43:2000

Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

(IEC 60601-2-43:2000)

—

—

Cenelec

EN 60601-2-44:2001

Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

(IEC 60601-2-44:2001)

EN 60601-2-44:1999

Note 2.1

Date expired

(1.7.2004)

Amendment A1:2003 to EN 60601-2-44:2001

(IEC 60601-2-44:2001/A1:2002)

Note 3

Date expired

(1.12.2005)

Cenelec

EN 60601-2-45:2001

Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

(IEC 60601-2-45:2001)

EN 60601-2-45:1998

Note 2.1

Date expired

(1.7.2004)

Cenelec

EN 60601-2-46:1998

Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables

(IEC 60601-2-46:1998)

—

—

Cenelec

EN 60601-2-47:2001

Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

(IEC 60601-2-47:2001)

—

—

Cenelec

EN 60601-2-49:2001

Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

(IEC 60601-2-49:2001)

—

—

Cenelec

EN 60601-2-50:2002

Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment

(IEC 60601-2-50:2000)

—

—

Cenelec

EN 60601-2-51:2003

Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

(IEC 60601-2-51:2003)

—

—

Cenelec

EN 60627:2001

Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids

(IEC 60627:2001)

—

—

Cenelec

EN 60645-1:2001

Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers

(IEC 60645-1:2001)

EN 60645-1:1994

Note 2.1

Date expired

(1.10.2004)

Cenelec

EN 60645-2:1997

Audiometers — Part 2: Equipment for speech audiometry

(IEC 60645-2:1993)

—

—

Cenelec

EN 60645-3:1995

Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes

(IEC 60645-3:1994)

—

—

Cenelec

EN 60645-3:2007

Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration

(IEC 60645-3:2007)

EN 60645-3:1995

Note 2.1

1.6.2010

Cenelec

EN 60645-4:1995

Audiometers — Part 4: Equipment for extended high-frequency audiometry

(IEC 60645-4:1994)

—

—

Cenelec

EN 61217:1996

Radiotherapy equipment — Coordinates, movements and scales

(IEC 61217:1996)

—

—

Amendment A1:2001 to EN 61217:1996

(IEC 61217:1996/A1:2000)

Note 3

Date expired

(1.12.2003)

Amendment A2:2008 to EN 61217:1996

(IEC 61217:1996/A2:2007)

Note 3

1.2.2011

Cenelec

EN 61676:2002

Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

(IEC 61676:2002)

—

—

Cenelec

EN 62083:2001

Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems

(IEC 62083:2000)

—

—

Cenelec

EN 62220-1:2004

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency

(IEC 62220-1:2003)

—

—

Cenelec

EN 62220-1-2:2007

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography

(IEC 62220-1-2:2007)

—

—

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

(IEC 62304:2006)

—

—

Cenelec

EN 62366:2008

Medical devices — Application of usability engineering to medical devices

(IEC 62366:2007)

—

—

| 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 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| 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.
  Example: For EN 60601-1:1990, the following applies:








  Cenelec | EN 60601-1:1990
  Medical electrical equipment
  Part 1: General requirements for safety
  IEC 60601-1:1988

  [The referenced standard is EN 60601-1:1990] | —
  [There is no superseded standard] | — |
| --- | --- | --- | --- | --- |
| Amendment A1:1993 to EN 60601-1:1990
  IEC 60601-1:1988/A1:1991

  [The referenced standard is EN 60601-1:1990


  - A1:1993 to EN 60601-1:1990] | Note 3

  [The superseded standard is EN 60601-1:1990] | — |
| Amendment A2:1995 to EN 60601-1:1990
  IEC 60601-1:1988/A2:1995

  [The referenced standard is EN 60601-1:1990


  - A1:1993 to EN 60601-1:1990


  - A2:1995 to EN 60601-1:1990] | Note 3

  [The superseded standard is EN 60601-1:1990


  - A1:1993] | — |
| Amendment A13:1996 to EN 60601-1:1990

  [The referenced standard is EN 60601-1:1990


  - A1:1993 to EN 60601-1:1990


  - A2:1995 to EN 60601-1:1990


  - A13:1996 to EN 60601-1:1990] | Note 3

  [The superseded standard is EN 60601-1:1990


  - A1:1993


  - A2:1995] | Date expired
  (1.7.1996) |

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.

Example: For EN 60601-1:1990, the following applies:

Cenelec

EN 60601-1:1990

Medical electrical equipment

Part 1: General requirements for safety

IEC 60601-1:1988

[The referenced standard is EN 60601-1:1990]

—

[There is no superseded standard]

—

Amendment A1:1993 to EN 60601-1:1990

IEC 60601-1:1988/A1:1991

[The referenced standard is EN 60601-1:1990

- A1:1993 to EN 60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990]

—

Amendment A2:1995 to EN 60601-1:1990

IEC 60601-1:1988/A2:1995

[The referenced standard is EN 60601-1:1990

- A1:1993 to EN 60601-1:1990

- A2:1995 to EN 60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993]

—

Amendment A13:1996 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

- A1:1993 to EN 60601-1:1990

- A2:1995 to EN 60601-1:1990

- A13:1996 to EN 60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993

- A2:1995]

Date expired

(1.7.1996)

---

(1)  ESO: European Standardisation Organisation:

| — | CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be), |
| --- | --- |

—

CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be),

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

—

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

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org). |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org).

---

| 27.11.2008 | EN | Official Journal of the European Union | C 304/17 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/17

---

Extract from the Decision concerning Kaupthing Bank Luxembourg SA pursuant to Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

(2008/C 304/07)

AMENDMENT TO THE JUDGMENT DECLARING A SUSPENSION OF PAYMENTS BY KAUPTHING BANK LUXEMBOURG SA

By Judgment delivered in public on 31 October 2008, the District Court of Luxembourg, second Chamber, hearing commercial, having heard, in closed session, the submissions of the administrators and representative of Kaupthing Bank Luxembourg SA, representatives of the Commission de Surveillance du Secteur Financier (Financial Sector Supervisory Commission) and a representative of the public prosecutor's office, has decided that its Judgment of 9 October 2008 allowing Kaupthing Bank Luxembourg SA to qualify under the suspension of payments procedure provided for in Part IV of the Law of 5 April 1993 on the financial sector, as amended, should be supplemented as follows:

‘instructs the appointed administrators to:

| — | take stock of the assets and liabilities of Kaupthing Bank Luxembourg SA by drawing up an inventory of the Bank's creditors and debtors, noting the due date and taking account of the status of the liens and mortgages, |
| --- | --- |

—

take stock of the assets and liabilities of Kaupthing Bank Luxembourg SA by drawing up an inventory of the Bank's creditors and debtors, noting the due date and taking account of the status of the liens and mortgages,

| — | draw up an inventory of transferable securities belonging to clients which are held by Kaupthing Bank Luxembourg SA, |
| --- | --- |

—

draw up an inventory of transferable securities belonging to clients which are held by Kaupthing Bank Luxembourg SA,

| — | establish whether Kaupthing Bank Luxembourg SA can be restructured, |
| --- | --- |

—

establish whether Kaupthing Bank Luxembourg SA can be restructured,

| — | if the answer is in the affirmative, draw up a recovery plan for Kaupthing Bank Luxembourg SA, |
| --- | --- |

—

if the answer is in the affirmative, draw up a recovery plan for Kaupthing Bank Luxembourg SA,

| — | ensure appropriate disclosure of the statement, accounts and inventories drawn up by the administrators by transmitting them to the Financial Sector Supervisory Commission, the public prosecutor's office, Kaupthing Bank Luxembourg SA and the District Court, |
| --- | --- |

—

ensure appropriate disclosure of the statement, accounts and inventories drawn up by the administrators by transmitting them to the Financial Sector Supervisory Commission, the public prosecutor's office, Kaupthing Bank Luxembourg SA and the District Court,

| — | declares that Article 61-17(3) of the Law of 5 April 1993 on the financial sector, as amended, is applicable to the branches in Belgium and Switzerland’, |
| --- | --- |

—

declares that Article 61-17(3) of the Law of 5 April 1993 on the financial sector, as amended, is applicable to the branches in Belgium and Switzerland’,

and amends the judgment of 9 October 2008 as follows:

‘declares that acts of management of a purely day-to-day nature that involve amounts of less than EUR 3 000 are not subject to approval by the administrators, specifying, however, that repayment of a deposit does not constitute an act of management of a day-to-day nature’.

The Financial Sector Supervisory Commission and Kaupthing Bank Luxembourg SA may lodge an appeal within 15 days of notification of the Judgment in accordance with paragraph 9 of Article 60-2 of the Law of 5 April 1993 on the financial sector, as amended, namely following notification of the Judgment by registered letter from the Registrar of the District Court of Luxembourg hearing commercial cases. The appeal shall be lodged by way of declaration to the Registrar.

This Judgment may not be the subject of an application to set aside nor of third-party proceedings for a re-hearing.

The administrators

PricewaterhouseCoopers SARL, represented by Ms Emmanuelle Caruel-Henniaux, and Mr Franz Fayot, lawyer

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

| 27.11.2008 | EN | Official Journal of the European Union | C 304/18 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/18

---

Notice concerning the anti-dumping measures in force in respect of imports into the Community of cotton-type bed linen originating in Pakistan: change of the address of a company subject to an individual anti-dumping duty

(2008/C 304/08)

Imports of cotton-type bed linen, originating in Pakistan are subject to a definitive anti-dumping duty, imposed by Council Regulation (EC) No 397/2004 (1) (‘Regulation (EC) No 397/2004’).

A.B. Exports (PVT) Ltd, a company located in Pakistan, whose exports to the Community of cotton-type bed linen are subject to an individual anti-dumping duty rate of 5,8 % imposed by Article 1(2) of Regulation (EC) No 397/2004, has informed the Commission that on 5 March 2008, it changed its address.

The company has argued that the change of address does not affect the right of the company to benefit from the individual duty rate applied to the company under its previous address of:

| Off. No 6, Ground Floor |
| --- |
| Business Center, New Civil Lines |
| Faisalabad |

Off. No 6, Ground Floor

Business Center, New Civil Lines

Faisalabad

The company submitted sufficient evidence to establish that the change of their registered address was due to closure of a city office and a transfer of its activity to an existing production facility of the company.

The Commission has examined the information supplied and concluded that the change of address in no way affects the findings of Regulation (EC) No 397/2004. Therefore, the reference, in the Annex of Regulation (EC) No 397/2004, to:

| A.B. Exports (PVT) Ltd |
| --- |
| Off. No 6, Ground Floor |
| Business Center, New Civil Lines |
| Faisalabad |

A.B. Exports (PVT) Ltd

Off. No 6, Ground Floor

Business Center, New Civil Lines

Faisalabad

should be read as:

| A.B. Exports (PVT) Ltd |
| --- |
| Lasani Pulli, Near Khayaban Gardens |
| Sargodha Road |
| Faisalabad |

A.B. Exports (PVT) Ltd

Lasani Pulli, Near Khayaban Gardens

Sargodha Road

Faisalabad

The Taric additional code A706 shall apply to:

| A.B. Exports (PVT) Ltd |
| --- |
| Lasani Pulli, Near Khayaban Gardens |
| Sargodha Road |
| Faisalabad |

A.B. Exports (PVT) Ltd

Lasani Pulli, Near Khayaban Gardens

Sargodha Road

Faisalabad

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(1)  OJ L 66, 4.3.2004, p. 1.

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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 27.11.2008 | EN | Official Journal of the European Union | C 304/19 |
| --- | --- | --- | --- |

27.11.2008

EN

Official Journal of the European Union

C 304/19

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Prior notification of a concentration

(Case COMP/M.5396 — En+/Russneft)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 304/09)

| 1. | On 18 November 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which En+ Group Limited (‘En+’, Jersey), ultimately controlled by the Basic Element Group, acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of OAO NK Russneft (‘Russneft’, Russia) and its subsidiaries by way of purchase of shares. |
| --- | --- |

1.

On 18 November 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which En+ Group Limited (‘En+’, Jersey), ultimately controlled by the Basic Element Group, acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of OAO NK Russneft (‘Russneft’, Russia) and its subsidiaries by way of purchase of shares.

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






  — | for En+ Group Limited (‘En+’, Jersey): different business activities in oil, energy, aluminium, coal and magnesium, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for En+ Group Limited (‘En+’, Jersey): different business activities in oil, energy, aluminium, coal and magnesium,

| — | for Basic Element Group: different business activities in (i) energy, aluminium, coal and magnesium; (ii) engineering/car manufacture; (iii) mining/commodities; (iv) financial services; (v) construction/construction material and (vi) real estate, |
| --- | --- |

—

for Basic Element Group: different business activities in (i) energy, aluminium, coal and magnesium; (ii) engineering/car manufacture; (iii) mining/commodities; (iv) financial services; (v) construction/construction material and (vi) real estate,

| — | for OAO NK Russneft (‘Russneft’, Russia): crude oil extraction, refining and retailing. |
| --- | --- |

—

for OAO NK Russneft (‘Russneft’, Russia): crude oil extraction, refining and retailing.

| 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.5396 — En+/Russneft, 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.5396 — En+/Russneft, 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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| 27.11.2008 | EN | Official Journal of the European Union | C 304/20 |
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27.11.2008

EN

Official Journal of the European Union

C 304/20

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Prior notification of a concentration

(Case COMP/M.5401 — REWE/Coop Switzerland/transGourmet Holding SE)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 304/10)

| 1. | On 18 November 2008, 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 REWE group (‘REWE’, Germany) and Coop eG (‘Coop’, Switzerland) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking transGourmet Holding SE (‘transGourmet’, Germany) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 18 November 2008, 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 REWE group (‘REWE’, Germany) and Coop eG (‘Coop’, Switzerland) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking transGourmet Holding SE (‘transGourmet’, Germany) by way of purchase of shares in a newly created company constituting a joint venture.

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






  — | for REWE: wholesale and retail of daily consumer goods and tourism industry, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for REWE: wholesale and retail of daily consumer goods and tourism industry,

| — | for Coop: wholesale and retail of consumer goods, |
| --- | --- |

—

for Coop: wholesale and retail of consumer goods,

| — | for transGourmet: wholesale of consumer goods. |
| --- | --- |

—

for transGourmet: wholesale of consumer goods.

| 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.5401 — REWE/Coop Switzerland/transGourmet Holding SE, 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.5401 — REWE/Coop Switzerland/transGourmet Holding SE, 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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| 27.11.2008 | EN | Official Journal of the European Union | C 304/21 |
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27.11.2008

EN

Official Journal of the European Union

C 304/21

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Prior notification of a concentration

(Case COMP/M.5405 — Hargreaves/Evonik/JV)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 304/11)

| 1. | On 20 November 2008, 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 Evonik Power Minerals GmbH (‘EPM GmbH’, Germany) (belonging to the group Evonik Industries AG) and Hargreaves Services plc (‘HS’, United Kingdom) (belonging to the Hargreaves Group) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Evonik Hargreaves Ltd (United Kingdom) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 20 November 2008, 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 Evonik Power Minerals GmbH (‘EPM GmbH’, Germany) (belonging to the group Evonik Industries AG) and Hargreaves Services plc (‘HS’, United Kingdom) (belonging to the Hargreaves Group) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking Evonik Hargreaves Ltd (United Kingdom) by way of purchase of shares in a newly created company constituting a joint venture.

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






  — | for EPM GmbH: provision of services to coal fired power plants regarding the waste management and the marketing of coal combustion products, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for EPM GmbH: provision of services to coal fired power plants regarding the waste management and the marketing of coal combustion products,

| — | for HS: mineral import, waste management and transportation and mining in the UK. |
| --- | --- |

—

for HS: mineral import, waste management and transportation and mining in the UK.

| 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.5405 — Hargreaves/Evonik/JV, 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.5405 — Hargreaves/Evonik/JV, 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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27.11.2008

| 27.11.2008 | EN | Official Journal of the European Union | C 304/s3 |
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EN

Official Journal of the European Union

C 304/s3

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NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.

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