# Official Journal C 186/2008

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 186 |
| | |
| English edition | Information and Notices | Volume 5123 July 2008 |

ISSN 1725-2423

Official Journal

of the European Union

C 186

English edition

Information and Notices

Volume 5123 July 2008

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 186/01 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections | 1 |
| 2008/C 186/02 | Initiation of proceedings (Case COMP/M.5046 — Friesland/Campina) (
  1
  ) | 5 |
| 2008/C 186/03 | Non-opposition to a notified concentration (Case COMP/M.5066 — Eurogate/APMM) (
  1
  ) | 6 |
| 2008/C 186/04 | Non-opposition to a notified concentration (Case COMP/M.5179 — Eramet/Tinfos) (
  1
  ) | 6 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 186/01

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

1

2008/C 186/02

Initiation of proceedings (Case COMP/M.5046 — Friesland/Campina) (
  1
  )

1

5

2008/C 186/03

Non-opposition to a notified concentration (Case COMP/M.5066 — Eurogate/APMM) (
  1
  )

1

6

2008/C 186/04

Non-opposition to a notified concentration (Case COMP/M.5179 — Eramet/Tinfos) (
  1
  )

1

6

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 186/05 | Euro exchange rates | 7 |
| 2008/C 186/06 | Communication from the Commission to all farmers concerning set aside from 2009 | 8 |
| | NOTICES FROM MEMBER STATES |
| 2008/C 186/07 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (
  1
  ) | 9 |
| 2008/C 186/08 | 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
  ) | 25 |
| 2008/C 186/09 | 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
  ) | 28 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 186/05

Euro exchange rates

7

2008/C 186/06

Communication from the Commission to all farmers concerning set aside from 2009

8

NOTICES FROM MEMBER STATES

2008/C 186/07

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

1

9

2008/C 186/08

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

25

2008/C 186/09

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

28

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY |
| | Commission |
| 2008/C 186/10 | Notice of initiation of an anti-dumping proceeding concerning imports of sodium metal originating in the United States of America | 32 |
| 2008/C 186/11 | Notice of initiation of an anti-subsidy proceeding concerning imports of sodium metal originating in the United States of America | 35 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2008/C 186/12 | Prior notification of a concentration (Case COMP/M.5201 — Total Produce/Haluco/JV) (
  1
  ) | 37 |
| 2008/C 186/13 | Prior notification of a concentration (Case COMP/M.5155 — Mondi/Loparex Assets) (
  1
  ) | 38 |
| 2008/C 186/14 | Prior notification of a concentration (Case COMP/M.5268 — Goldman Sachs/PAI/Xella International) — Candidate case for simplified procedure (
  1
  ) | 39 |
| 2008/C 186/15 | Prior notification of a concentration (Case COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales) — Candidate case for simplified procedure (
  1
  ) | 40 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

2008/C 186/10

Notice of initiation of an anti-dumping proceeding concerning imports of sodium metal originating in the United States of America

32

2008/C 186/11

Notice of initiation of an anti-subsidy proceeding concerning imports of sodium metal originating in the United States of America

35

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2008/C 186/12

Prior notification of a concentration (Case COMP/M.5201 — Total Produce/Haluco/JV) (
  1
  )

1

37

2008/C 186/13

Prior notification of a concentration (Case COMP/M.5155 — Mondi/Loparex Assets) (
  1
  )

1

38

2008/C 186/14

Prior notification of a concentration (Case COMP/M.5268 — Goldman Sachs/PAI/Xella International) — Candidate case for simplified procedure (
  1
  )

1

39

2008/C 186/15

Prior notification of a concentration (Case COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales) — Candidate case for simplified procedure (
  1
  )

1

40

| | Corrigenda |
| --- | --- |
| 2008/C 186/16 | Corrigendum to notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (OJ C 179, 16.7.2008) | 41 |

Corrigenda

2008/C 186/16

Corrigendum to notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (OJ C 179, 16.7.2008)

(OJ C 179, 16.7.2008)

41

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 23.7.2008 | EN | Official Journal of the European Union | C 186/1 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/1

---

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

Cases where the Commission raises no objections

(2008/C 186/01)

| Date of adoption of the decision | 13.2.2008 |
| --- | --- |
| Reference number of the aid | N 130a/07 |
| Member State | Finland |
| Region | — |
| Title (and/or name of the beneficiary) | Tuki metsäalalle |
| Legal basis | Laki kestävän metsätalouden rahoituksesta; Asetus kestävän metsätalouden rahoituksesta |
| Type of measure | Aid scheme |
| Objective | Maintaining and restoring ecological, protective and recreational functions of forests, biodiversity and healthy forest ecosystems |
| Form of aid | Subsidy |
| Budget | EUR 90 million annually |
| Intensity | Variable |
| Duration | Until 31.12.2013 |
| Economic sectors | Forestry |
| Name and address of the granting authority | Maa- ja metsätalousministeriö |
| PL 30 |
| FI-00023 Valtioneuvosto (Helsinki) |

Date of adoption of the decision

13.2.2008

Reference number of the aid

N 130a/07

Member State

Finland

Region

—

Title (and/or name of the beneficiary)

Tuki metsäalalle

Legal basis

Laki kestävän metsätalouden rahoituksesta; Asetus kestävän metsätalouden rahoituksesta

Type of measure

Aid scheme

Objective

Maintaining and restoring ecological, protective and recreational functions of forests, biodiversity and healthy forest ecosystems

Form of aid

Subsidy

Budget

EUR 90 million annually

Intensity

Variable

Duration

Until 31.12.2013

Economic sectors

Forestry

Name and address of the granting authority

Maa- ja metsätalousministeriö

PL 30

FI-00023 Valtioneuvosto (Helsinki)

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 | 19.3.2008 |
| --- | --- |
| Reference number of the aid | N 314/07 |
| Member State | Cyprus |
| Region | — |
| Title (and/or name of the beneficiary) | Καθεστώς ενισχύσεων για ενέργειες προώθησης και διαφήμισης γεωργικών προϊόντων στην εσωτερική αγορά και τις τρίτες χώρες |
| Legal basis | Προεδρικό διάταγμα |
| Type of measure | Aid scheme |
| Objective | To grant aid for promotion and advertising measures |
| Form of aid | Direct grant |
| Budget | EUR 14 500 000 |
| Intensity | Up to 100 % for promotion aid
  Up to 40 % for advertising aid |
| Duration | 5 years |
| Economic sectors | Agriculture |
| Name and address of the granting authority | Υπουργείο Εμπορίου, Βιομηχανίας και Τουρισμού/Ministry of Commerce, Industry and Tourism |
| Υπηρεσία Εμπορίου — Κλάδος προώθησης γεωργικών προϊόντων/Trade Service — Promotion of Agricultural Products Section |
| CY-1421 Λευκωσία/CY-1421 Nicosia |

Date of adoption of the decision

19.3.2008

Reference number of the aid

N 314/07

Member State

Cyprus

Region

—

Title (and/or name of the beneficiary)

Καθεστώς ενισχύσεων για ενέργειες προώθησης και διαφήμισης γεωργικών προϊόντων στην εσωτερική αγορά και τις τρίτες χώρες

Legal basis

Προεδρικό διάταγμα

Type of measure

Aid scheme

Objective

To grant aid for promotion and advertising measures

Form of aid

Direct grant

Budget

EUR 14 500 000

Intensity

Up to 100 % for promotion aid

Up to 40 % for advertising aid

Duration

5 years

Economic sectors

Agriculture

Name and address of the granting authority

Υπουργείο Εμπορίου, Βιομηχανίας και Τουρισμού/Ministry of Commerce, Industry and Tourism

Υπηρεσία Εμπορίου — Κλάδος προώθησης γεωργικών προϊόντων/Trade Service — Promotion of Agricultural Products Section

CY-1421 Λευκωσία/CY-1421 Nicosia

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 | 13.2.2008 |
| --- | --- |
| Aid number | N 438/A/07 |
| Member State | Federal Republic of Germany |
| Region | Mecklenburg-Vorpommern |
| Title (and/or name of the beneficiary) | Forstmaßnahmen |
| Legal basis | Richtlinie zur Förderung forstwirtschaftlicher Maßnahmen im Rahmen des Europäischen Landwirtschaftsfonds für die Entwicklung des ländlichen Raums (FöRiForst-ELER M-V) |
| Type of measure | Aid scheme |
| Objective | To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system |
| Form of aid | Subsidy |
| Budget | EUR 32 800 000 |
| Intensity | Variable |
| Duration | 2007-2015 |
| Economic sectors | Agriculture |
| Name and address of the granting authority | Ministerium für Landwirtschaft, Umwelt und Verbraucherschutz M-V |
| D-19053 Schwerin |

Date of adoption of the decision

13.2.2008

Aid number

N 438/A/07

Member State

Federal Republic of Germany

Region

Mecklenburg-Vorpommern

Title (and/or name of the beneficiary)

Forstmaßnahmen

Legal basis

Richtlinie zur Förderung forstwirtschaftlicher Maßnahmen im Rahmen des Europäischen Landwirtschaftsfonds für die Entwicklung des ländlichen Raums (FöRiForst-ELER M-V)

Type of measure

Aid scheme

Objective

To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system

Form of aid

Subsidy

Budget

EUR 32 800 000

Intensity

Variable

Duration

2007-2015

Economic sectors

Agriculture

Name and address of the granting authority

Ministerium für Landwirtschaft, Umwelt und Verbraucherschutz M-V

D-19053 Schwerin

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 | 30.1.2008 |
| --- | --- |
| Aid number | N 445/07 |
| Member State | Federal Republic of Germany |
| Region | Niedersachsen |
| Title (and/or name of the beneficiary) | Forstbeihilfen |
| Legal basis | 1. | Richtlinie über die Gewährung von Zuwendungen zur Förderung forstwirtschaftlicher Maßnahmen in den Ländern Niedersachsen und Bremen |

Date of adoption of the decision

30.1.2008

Aid number

N 445/07

Member State

Federal Republic of Germany

Region

Niedersachsen

Title (and/or name of the beneficiary)

Forstbeihilfen

Legal basis

1.

Richtlinie über die Gewährung von Zuwendungen zur Förderung forstwirtschaftlicher Maßnahmen in den Ländern Niedersachsen und Bremen

| 2. | Maßnahme „Wiederaufbau des forstwirtschaftlichen Potenzials und Einführung vorbeugender Aktionen“, „PROFIL 2007-2013“ Programm zur Förderung im ländlichen Raum Niedersachsen und Bremen |
| --- | --- |

2.

Maßnahme „Wiederaufbau des forstwirtschaftlichen Potenzials und Einführung vorbeugender Aktionen“, „PROFIL 2007-2013“ Programm zur Förderung im ländlichen Raum Niedersachsen und Bremen

Type of measure

Aid scheme

Objective

| 1. | To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system. |
| --- | --- |

1.

To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system.

| 2. | To restore forestry potential and introduce prevention actions (Code 226) in accordance with Article 36(b)(vi) and Article 48 of the Regulation (EC) No 1698/2005 |
| --- | --- |

2.

To restore forestry potential and introduce prevention actions (Code 226) in accordance with Article 36(b)(vi) and Article 48 of the Regulation (EC) No 1698/2005

Form of aid

Subsidy

Budget

EUR 4 500 000

Maximum aid intensity

100 %

Duration

2007-2013

Economic sectors

Agriculture

Name and address of the granting authority

| Landwirtschaftskammer Niedersachsen |
| --- |
| Geschäftsbereich Förderung |
| Johannssenstr. 10 |
| D-30159 Hannover |

Landwirtschaftskammer Niedersachsen

Geschäftsbereich Förderung

Johannssenstr. 10

D-30159 Hannover

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 | 3.6.2008 |
| --- | --- |
| Reference number of the aid | N 514/07 |
| Member State | Hungary |
| Region | — |
| Title (and/or name of the beneficiary) | 2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők által igénybe vehető kedvezményes hitel |
| Legal basis | — | A földművelésügyi és vidékfejlesztési miniszter .../2007. (...) FVM rendelete a 2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők hitelhez jutási lehetőségéről; |

Date of adoption of the decision

3.6.2008

Reference number of the aid

N 514/07

Member State

Hungary

Region

—

Title (and/or name of the beneficiary)

2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők által igénybe vehető kedvezményes hitel

Legal basis

—

A földművelésügyi és vidékfejlesztési miniszter .../2007. (...) FVM rendelete a 2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők hitelhez jutási lehetőségéről;

| — | A nemzeti agrárkár-enyhítési rendszerről szóló 2006. évi LXXXVIII. törvény |
| --- | --- |

—

A nemzeti agrárkár-enyhítési rendszerről szóló 2006. évi LXXXVIII. törvény

Type of measure

Aid scheme

Objective

Compensation for damages caused by the 2007 spring frost to grape and fruit producers

Form of aid

Interest rate subsidy and State guarantee

Budget

Overall budget: HUF 160 million

Intensity

The aid intensity of the preferential loan and the State guarantee will be 22 %. The overall aid intensity resulting from the damage compensation provided by the National Damage Mitigation Act, the preferential loan and the State guarantee must not exceed 80 % of the production loss

Duration

Three months from the approval by the Commission

Economic sectors

Agriculture

Name and address of the granting authority

| Ministry of Agriculture and Rural Development |
| --- |
| Kossuth Lajos tér 11 |
| H-1055 Budapest |

Ministry of Agriculture and Rural Development

Kossuth Lajos tér 11

H-1055 Budapest

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/

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/5 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/5

---

Initiation of proceedings

(Case COMP/M.5046 — Friesland/Campina)

(Text with EEA relevance)

(2008/C 186/02)

On 17 July 2008, the Commission decided to initiate proceedings in the above-mentioned case after finding that the notified concentration raises serious doubts as to its compatibility with the common market. The initiation of proceedings opens a second phase investigation with regard to the notified concentration, and is without prejudice to the final decision on the case. The decision is based on Article 6(1)(c) of Council Regulation (EC) No 139/2004.

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

In order to be fully taken into account in the procedure, observations should reach the Commission not later than 15 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 COMP/M.5046 — Friesland/Campina, to the following address:

| Commission of the European Communities |
| --- |
| Competition DG |
| Merger Registry |
| Rue Joseph II/Jozef II-straat 70 |
| B-1000 Brussels |

Commission of the European Communities

Competition DG

Merger Registry

Rue Joseph II/Jozef II-straat 70

B-1000 Brussels

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/6 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/6

---

Non-opposition to a notified concentration

(Case COMP/M.5066 — Eurogate/APMM)

(Text with EEA relevance)

(2008/C 186/03)

On 5 June 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 English 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 32008M5066. 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 32008M5066. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/6 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/6

---

Non-opposition to a notified concentration

(Case COMP/M.5179 — Eramet/Tinfos)

(Text with EEA relevance)

(2008/C 186/04)

On 3 July 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 English 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 32008M5179. 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 32008M5179. 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

| 23.7.2008 | EN | Official Journal of the European Union | C 186/7 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/7

---

Euro exchange rates (1)

22 July 2008

(2008/C 186/05)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,5919 |
| JPY | Japanese yen | 169,26 |
| DKK | Danish krone | 7,4610 |
| GBP | Pound sterling | 0,79355 |
| SEK | Swedish krona | 9,4763 |
| CHF | Swiss franc | 1,6174 |
| ISK | Iceland króna | 126,67 |
| NOK | Norwegian krone | 8,0555 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 23,013 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 229,07 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7034 |
| PLN | Polish zloty | 3,2308 |
| RON | Romanian leu | 3,5635 |
| SKK | Slovak koruna | 30,363 |
| TRY | Turkish lira | 1,9054 |
| AUD | Australian dollar | 1,6284 |
| CAD | Canadian dollar | 1,5943 |
| HKD | Hong Kong dollar | 12,4119 |
| NZD | New Zealand dollar | 2,0876 |
| SGD | Singapore dollar | 2,1540 |
| KRW | South Korean won | 1 618,96 |
| ZAR | South African rand | 12,0362 |
| CNY | Chinese yuan renminbi | 10,8595 |
| HRK | Croatian kuna | 7,2175 |
| IDR | Indonesian rupiah | 14 562,70 |
| MYR | Malaysian ringgit | 5,1530 |
| PHP | Philippine peso | 70,760 |
| RUB | Russian rouble | 36,9075 |
| THB | Thai baht | 53,090 |
| BRL | Brazilian real | 2,5168 |
| MXN | Mexican peso | 16,1339 |

Currency

Exchange rate

USD

US dollar

1,5919

JPY

Japanese yen

169,26

DKK

Danish krone

7,4610

GBP

Pound sterling

0,79355

SEK

Swedish krona

9,4763

CHF

Swiss franc

1,6174

ISK

Iceland króna

126,67

NOK

Norwegian krone

8,0555

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

23,013

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

229,07

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7034

PLN

Polish zloty

3,2308

RON

Romanian leu

3,5635

SKK

Slovak koruna

30,363

TRY

Turkish lira

1,9054

AUD

Australian dollar

1,6284

CAD

Canadian dollar

1,5943

HKD

Hong Kong dollar

12,4119

NZD

New Zealand dollar

2,0876

SGD

Singapore dollar

2,1540

KRW

South Korean won

1 618,96

ZAR

South African rand

12,0362

CNY

Chinese yuan renminbi

10,8595

HRK

Croatian kuna

7,2175

IDR

Indonesian rupiah

14 562,70

MYR

Malaysian ringgit

5,1530

PHP

Philippine peso

70,760

RUB

Russian rouble

36,9075

THB

Thai baht

53,090

BRL

Brazilian real

2,5168

MXN

Mexican peso

16,1339

---

(1)

Source: reference exchange rate published by the ECB.

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/8 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/8

---

Communication from the Commission to all farmers concerning set aside from 2009

(2008/C 186/06)

The Commission wishes to draw the attention of Community farmers to the Health Check proposal (COM(2008) 306 final (1)) to abolish compulsory set aside as from 2009 onwards. The proposal was adopted by the Commission on 20 May 2008 and it is currently under discussion in the Council, the European Parliament and the other European Institutions.

The proposal is the logical follow-up of Council Regulation (EC) No 1107/2007 (2) fixing the rate for compulsory set aside at zero in 2008.

Under the proposal, farmers will not be obliged to set aside land from production in order to be entitled to the amount fixed by the set-aside entitlements. The set-aside entitlements will be turned to normal entitlements. Farmers could already benefit from the measure as from their autumn 2008 and spring 2009 sowings.

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(1)  COM(2008) 306: Proposal for a Council Regulation establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers; proposal for a Council Regulation on modifications to the common agricultural policy by amending Regulations (EC) No 320/2006, (EC) No 1234/2007, (EC) No 3/2008 and (EC) No [...]/2008; proposal for a Council Regulation amending Regulation (EC) No 1698/2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD).

(2)  Council Regulation (EC) No 1107/2007 of 26 September 2007 derogating from Regulation (EC) No 1782/2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers, as regards set aside for the year 2008 (OJ L 253, 28.9.2007, p. 1).

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NOTICES FROM MEMBER STATES

| 23.7.2008 | EN | Official Journal of the European Union | C 186/9 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/9

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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)

(2008/C 186/07)

| 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 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 556:1994 + 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 737-1:1998
  Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum | — | |
| CEN | EN 737-4:1998
  Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems | — | |
| 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 1041:1998
  Information supplied by the manufacturer with medical devices | — | |
| 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 3826-3:2007
  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 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 | 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 | 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 | 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 10993-9:1999
  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 12011:1998
  Instrumentation to be used in association with non-active surgical implants — General requirements | — | |
| CEN | EN 12182:1999
  Technical aids for disabled persons — General requirements and test methods | — | |
| 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 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 12870:1997 | Date expired
  (28.2.2005) |
| EN ISO 12870:2004/AC:2005 | | |
| CEN | EN 13014:2000
  Connections for gas sampling tubes to anaesthetic and respiratory equipment | — | |
| CEN | EN 13060:2004
  Small steam sterilizers | — | |
| CEN | EN 13220:1998
  Flow-metering devices for connection to terminal units of medical gas pipeline systems | — | |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN 46003:1999
  EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2009 |
| EN ISO 13485:2003/AC:2007 | | |
| 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 13718-1:2002
  Air, water and difficult terrain ambulances — Part 1: Medical device interface requirements for the continuity of patient care | — | |
| 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 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 14299:2004
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Specific requirements for arterial stents | — | |
| 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 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 | 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 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 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 12598:1999
  EN 864:1996
  EN ISO 11196:1997 | Date expired
  (31.5.2005) |
| EN ISO 21647:2004/AC:2006 | | |
| 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 | 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 | 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 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 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 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 556:1994 + 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 737-1:1998

Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum

—

CEN

EN 737-4:1998

Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems

—

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 1041:1998

Information supplied by the manufacturer with medical devices

—

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 3826-3:2007

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 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

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

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

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 10993-9:1999

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 12011:1998

Instrumentation to be used in association with non-active surgical implants — General requirements

—

CEN

EN 12182:1999

Technical aids for disabled persons — General requirements and test methods

—

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 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 12870:1997

Date expired

(28.2.2005)

EN ISO 12870:2004/AC:2005

CEN

EN 13014:2000

Connections for gas sampling tubes to anaesthetic and respiratory equipment

—

CEN

EN 13060:2004

Small steam sterilizers

—

CEN

EN 13220:1998

Flow-metering devices for connection to terminal units of medical gas pipeline systems

—

CEN

EN ISO 13485:2003

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

EN 46003:1999

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2009

EN ISO 13485:2003/AC:2007

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 13718-1:2002

Air, water and difficult terrain ambulances — Part 1: Medical device interface requirements for the continuity of patient care

—

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 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 14299:2004

Non active surgical implants — Particular requirements for cardiac and vascular implants — Specific requirements for arterial stents

—

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 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

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 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 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 12598:1999

EN 864:1996

EN ISO 11196:1997

Date expired

(31.5.2005)

EN ISO 21647:2004/AC:2006

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

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

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 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.

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/25 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/25

---

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)

(2008/C 186/08)

| 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 46003:1999
  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 46003:1999

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.

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/28 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/28

---

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)

(2008/C 186/09)

| 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 1041:1998
  Information supplied by the manufacturer with medical devices | — | |
| 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 46003:1999
  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 1041:1998

Information supplied by the manufacturer with medical devices

—

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 46003:1999

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.

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

| 23.7.2008 | EN | Official Journal of the European Union | C 186/32 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/32

---

Notice of initiation of an anti-dumping proceeding concerning imports of sodium metal originating in the United States of America

(2008/C 186/10)

The Commission has received a complaint pursuant to Article 5 of Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of sodium metal, originating in the United States of America (‘the country concerned’), are being dumped and are thereby causing material injury to the Community industry.

1.   Complaint

The complaint was lodged on 10 June 2008 by the sole Community producer Métaux Spéciaux (‘MSSA SAS’) (‘the complainant’).

2.   Product

The product allegedly being dumped is sodium, in bulk, originating in the United States of America (‘the product concerned’), normally declared within CN code ex 2805 11 00. This CN code is only given for information.

3.   Allegation of dumping

The allegation of dumping in respect of the United States of America is based on a comparison of normal value established on the basis of domestic prices, with the export prices of the product concerned when sold for export to the Community.

On this basis, the dumping margin calculated is significant.

4.   Allegation of injury

The complainant has provided evidence that imports of the product concerned from the United States of America have increased overall in absolute terms and in terms of market share.

It is alleged that the volumes and the prices of the imported product concerned have, among other consequences, had a negative impact on the market share held and the level of prices charged by the Community industry, resulting in substantial adverse effects on the overall performance, the financial situation and the employment situation of the Community industry.

5.   Procedure

Having determined, after consulting the Advisory Committee, that the complaint has been lodged by or on behalf of the Community industry and that there is sufficient evidence to justify the initiation of a proceeding, the Commission hereby initiates an investigation pursuant to Article 5 of the basic Regulation.

5.1.   Procedure for the determination of dumping and injury

The investigation will determine whether the product concerned originating in the United States of America is being dumped and whether this dumping has caused injury.

(a)   Questionnaires

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the Community industry and to any association of producers in the Community, to the exporters/producers in the United States of America, to any association of exporters/producers, to the importers, to any known association of importers, and to the authorities of the exporting country concerned.

(b)   Collection of information and holding of hearings

All interested parties are hereby invited to make their views known, submit information other than questionnaire replies and to provide supporting evidence. This information and supporting evidence has to reach the Commission within the time limit set in point 6(b).

Furthermore, the Commission may hear interested parties, provided that they make a request showing that there are particular reasons why they should be heard. This request must be made within the time limit set in point 6(c).

5.2.   Procedure for assessment of Community interest

In accordance with Article 21 of the basic Regulation and in the event that the allegations of dumping and injury caused thereby are substantiated, a decision will be reached as to whether the adoption of anti-dumping measures would not be against the Community interest. For this reason the Commission may send questionnaires to the known Community industry, importers, their representative associations, representative users and representative consumer organisations. Such parties, including those not known to the Commission, provided that they prove that there is an objective link between their activity and the product concerned, may, within the time limits set in point 6(b), make themselves known and provide the Commission with information. The parties which have acted in conformity with the preceding sentence may request a hearing setting the particular reasons why they should be heard within the time limit set in point 6(c). It should be noted that any information submitted pursuant to Article 21 of the basic Regulation will only be taken into account if supported by factual evidence at the time of submission.

6.   Time limits

(a)   For parties to request a questionnaire

All interested parties should request a questionnaire, as soon as possible, but not later than 15 days after the publication of this notice in the Official Journal of the European Union.

(b)   For parties to make themselves known, to submit questionnaire replies and any other information

All interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views and submit questionnaire replies or any other information within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. Attention is drawn to the fact that the exercise of most procedural rights set out in the basic Regulation depends on the party's making itself known within the aforementioned period.

(c)   Hearings

All interested parties may also apply to be heard by the Commission within the same 40-day time limit.

7.   Written submissions, questionnaire replies and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified) and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. All written submissions, including the information requested in this notice, questionnaire replies and correspondence provided by interested parties on a confidential basis shall be labelled as ‘Limited’ (2) and, in accordance with Article 19(2) of the basic Regulation, shall be accompanied by a non-confidential version, which will be labelled ‘For inspection by interested parties’.

Commission address for correspondence:

| European Commission |
| --- |
| Directorate-General for Trade |
| Directorate H |
| Office: J-79 4/23 |
| B-1049 Brussels |
| Fax (32-2) 295 65 05 |

European Commission

Directorate-General for Trade

Directorate H

Office: J-79 4/23

B-1049 Brussels

Fax (32-2) 295 65 05

8.   Non-cooperation

In cases in which any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made in accordance with Article 18 of the basic Regulation, on the basis of the facts available.

Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of the facts available. If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

9.   Schedule of the investigation

The investigation will be concluded, according to Article 6(9) of the basic Regulation within 15 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 7(1) of the basic Regulation, provisional measures may be imposed no later than 9 months from the publication of this notice in the Official Journal of the European Union.

10.   Processing of personal data

It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

11.   Hearing Officer

It is also noted that if interested parties consider that they are encountering difficulties in the exercise of their rights of defence, they may request the intervention of the Hearing Officer of DG Trade. He acts as an interface between the interested parties and the Commission services, offering, where necessary, mediation on procedural matters affecting the protection of their interests in this proceeding, in particular, with regard to issues concerning access to file, confidentiality, extension of time limits and the treatment of written and/or oral submission of views. For further information and contact details interested parties may consult the Hearing Officer's web pages of the website of DG Trade (http://ec.europa.eu/trade).

---

(1)  OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Regulation (EC) No 2117/2005 (OJ L 340, 23.12.2005, p. 17).

(2)  This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 19 of the basic Regulation and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-dumping Agreement).

(3)  OJ L 8, 12.1.2001, p. 1.

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/35 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/35

---

Notice of initiation of an anti-subsidy proceeding concerning imports of sodium metal originating in the United States of America

(2008/C 186/11)

The Commission has received a complaint pursuant to Article 10 of Council Regulation (EC) No 2026/97 on protection against subsidised imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of sodium metal, originating in the United States of America (‘the country concerned’), are being subsidised and are thereby causing material injury to the Community industry.

1.   Complaint

The complaint was lodged on 10 June 2008 by the sole Community producer Métaux Spéciaux (MSSA SAS) (‘the complainant’).

2.   Product

The product allegedly being subsidised is sodium, in bulk, originating in the United States of America (‘the product concerned’), normally declared within CN code ex 2805 11 00. This CN code is only given for information.

3.   Allegation of subsidisation

It is alleged that the producers of the product concerned from the United States of America have benefited from a number of State subsidies granted by the Government of the State of New York. The subsidies consist of allocations in the framework of the New York State Power Programs for Economic Development: ‘Replacement Power’ and ‘Expansion Power’.

It is alleged that the above schemes are subsidies since they involve a financial contribution from the Government of the United States of America or other state Governments and confer a benefit to the recipients, i.e. to exporters/producers of sodium metal. They are alleged to be limited to specific companies and therefore specific and countervailable.

4.   Allegation of injury

The complainant has provided evidence that imports of the product concerned from the United States of America have increased overall in absolute terms and in terms of market share.

It is alleged that the volumes and the prices of the imported product concerned have, among other consequences, had a negative impact on the market share held and the level of prices charged by the Community industry, resulting in substantial adverse effects on the overall performance, the financial situation and the employment situation of the Community industry.

5.   Procedure

Having determined, after consulting the Advisory Committee, that the complaint has been lodged by or on behalf of the Community industry and that there is sufficient evidence to justify the initiation of a proceeding, the Commission hereby initiates an investigation pursuant to Article 10 of the basic Regulation.

5.1.   Procedure for the determination of subsidisation and injury

The investigation will determine whether the product concerned originating in the United States of America is being subsidised and whether this subsidisation has caused injury.

(a)   Questionnaires

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the Community industry and to any association of producers in the Community, to the exporters/producers in the United States of America, to any association of exporters/producers, to the importers, to any known association of importers, and to the authorities of the exporting country concerned.

(b)   Collection of information and holding of hearings

All interested parties are hereby invited to make their views known, submit information other than questionnaire replies and to provide supporting evidence. This information and supporting evidence has to reach the Commission within the time limit set in point 6(b).

Furthermore, the Commission may hear interested parties, provided that they make a request showing that there are particular reasons why they should be heard. This request must be made within the time limit set in point 6(c).

5.2.   Procedure for assessment of Community interest

In accordance with Article 31 of the basic Regulation and in the event that the allegations of subsidisation and injury caused thereby are substantiated, a decision will be reached as to whether the adoption of countervailing measures would not be against the Community interest. For this reason the Commission may send questionnaires to the known Community industry, importers, their representative associations, representative users and representative consumer organisations. Such parties, including those not known to the Commission, provided that they prove that there is an objective link between their activity and the product concerned, may, within the time limits set in point 6(b), make themselves known and provide the Commission with information. The parties which have acted in conformity with the preceding sentence may request a hearing setting the particular reasons why they should be heard within the time limit set in point 6(c). It should be noted that any information submitted pursuant to Article 31 of the basic Regulation will only be taken into account if supported by factual evidence at the time of submission.

6.   Time limits

(a)   For parties to request a questionnaire

All interested parties should request a questionnaire as soon as possible, but not later than 15 days after the publication of this notice in the Official Journal of the European Union.

(b)   For parties to make themselves known, to submit questionnaire replies and any other information

All interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views and submit questionnaire replies or any other information within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. Attention is drawn to the fact that the exercise of most procedural rights set out in the basic Regulation depends on the party's making itself known within the aforementioned period.

(c)   Hearings

All interested parties may also apply to be heard by the Commission within the same 40-day time limit.

7.   Written submissions, questionnaire replies and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified) and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. All written submissions, including the information requested in this notice, questionnaire replies and correspondence provided by interested parties on a confidential basis shall be labelled as ‘Limited’ (2) and, in accordance with Article 29(2) of the basic Regulation, shall be accompanied by a non-confidential version, which will be labelled ‘For inspection by interested parties’.

Commission address for correspondence:

| European Commission |
| --- |
| Directorate-General for Trade |
| Directorate H |
| Office: J-79 4/23 |
| B-1049 Brussels |
| Fax (32-2) 295 65 05 |

European Commission

Directorate-General for Trade

Directorate H

Office: J-79 4/23

B-1049 Brussels

Fax (32-2) 295 65 05

8.   Non-cooperation

In cases in which any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made in accordance with Article 28 of the basic Regulation, on the basis of the facts available.

Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of the facts available. If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 28 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

9.   Schedule of the investigation

The investigation will be concluded, according to Article 11(9) of the basic Regulation within 13 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 12(1) of the basic Regulation, provisional measures may be imposed no later than 9 months from the publication of this notice in the Official Journal of the European Union.

10.   Processing of personal data

It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

11.   Hearing Officer

It is also noted that if interested parties consider that they are encountering difficulties in the exercise of their rights of defence, they may request the intervention of the Hearing Officer of DG Trade. He acts as an interface between the interested parties and the Commission services, offering, where necessary, mediation on procedural matters affecting the protection of their interests in this proceeding, in particular, with regard to issues concerning access to file, confidentiality, extension of time limits and the treatment of written and/or oral submission of views. For further information and contact details interested parties may consult the Hearing Officer's web pages of the website of DG Trade (http://ec.europa.eu/trade).

---

(1)  OJ L 288, 21.10.1997, p. 1. Regulation as last amended by Regulation (EC) No 461/2004 (OJ L 77, 13.3.2004, p. 12).

(2)  This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 29 of the basic Regulation and Article 12 of the WTO Agreement on Subsidies and Countervailing Measures.

(3)  OJ L 8, 12.1.2001, p. 1.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 23.7.2008 | EN | Official Journal of the European Union | C 186/37 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/37

---

Prior notification of a concentration

(Case COMP/M.5201 — Total Produce/Haluco/JV)

(Text with EEA relevance)

(2008/C 186/12)

| 1. | On 4 July 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 Total Produce plc (‘Total Produce’, Ireland) and Haluco Beheer BV (‘Haluco’, the Netherlands) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertakings TP Haluco Holding BV (‘TP Haluco’, the Netherlands) and Total Produce will acquire sole control of Haluco UK Ltd (‘Haluco UK’, United Kingdom) by way of purchase of shares. |
| --- | --- |

1.

On 4 July 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 Total Produce plc (‘Total Produce’, Ireland) and Haluco Beheer BV (‘Haluco’, the Netherlands) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertakings TP Haluco Holding BV (‘TP Haluco’, the Netherlands) and Total Produce will acquire sole control of Haluco UK Ltd (‘Haluco UK’, United Kingdom) by way of purchase of shares.

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






  — | for undertaking Total Produce: procurement, importation, marketing and distribution of fruit and vegetables, pot plants and household items, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for undertaking Total Produce: procurement, importation, marketing and distribution of fruit and vegetables, pot plants and household items,

| — | for undertaking Haluco: procurement, importation, marketing and distribution of fresh products, |
| --- | --- |

—

for undertaking Haluco: procurement, importation, marketing and distribution of fresh products,

| — | for undertaking TP Haluco: procurement, importation, marketing and distribution of fresh products, |
| --- | --- |

—

for undertaking TP Haluco: procurement, importation, marketing and distribution of fresh products,

| — | for undertaking Haluco UK: wholesale distribution of fresh products. |
| --- | --- |

—

for undertaking Haluco UK: wholesale distribution of fresh products.

| 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. |
| --- | --- |

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.

| 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.5201 — Total Produce/Haluco/JV to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

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.5201 — Total Produce/Haluco/JV to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/38 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/38

---

Prior notification of a concentration

(Case COMP/M.5155 — Mondi/Loparex Assets)

(Text with EEA relevance)

(2008/C 186/13)

| 1. | On 14 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking Mondi Coating BV (The Netherlands) controlled by Mondi plc (‘Mondi’, United Kingdom) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the undertaking Loparex Holding BV (‘Loparex Assets’, The Netherlands) by way of purchase of assets. |
| --- | --- |

1.

On 14 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking Mondi Coating BV (The Netherlands) controlled by Mondi plc (‘Mondi’, United Kingdom) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the undertaking Loparex Holding BV (‘Loparex Assets’, The Netherlands) by way of purchase of assets.

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






  — | for Mondi: manufacture of packaging paper, converted packaging products and uncoated fine paper as well as merchant operations and newsprint operations, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Mondi: manufacture of packaging paper, converted packaging products and uncoated fine paper as well as merchant operations and newsprint operations,

| — | for Loparex Assets: manufacture of release liners, kraft paper and extrusion coating products. |
| --- | --- |

—

for Loparex Assets: manufacture of release liners, kraft paper and extrusion coating products.

| 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. |
| --- | --- |

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.

| 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.5155 — Mondi/Loparex Assets, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

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.5155 — Mondi/Loparex Assets, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/39 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/39

---

Prior notification of a concentration

(Case COMP/M.5268 — Goldman Sachs/PAI/Xella International)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 186/14)

| 1. | On 15 July 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 Goldman Sachs Group Inc. (‘Goldman Sachs’, USA) and PAI Partners SAS (‘PAI’, France) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Xella International GmbH (‘Xella’, Germany) by way of purchase of shares |
| --- | --- |

1.

On 15 July 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 Goldman Sachs Group Inc. (‘Goldman Sachs’, USA) and PAI Partners SAS (‘PAI’, France) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Xella International GmbH (‘Xella’, Germany) by way of purchase of shares

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






  — | for Goldman Sachs: global investment banking, financial services, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Goldman Sachs: global investment banking, financial services,

| — | for PAI: private equity, |
| --- | --- |

—

for PAI: private equity,

| — | for Xella: building materials for walls, limestone products. |
| --- | --- |

—

for Xella: building materials for walls, limestone products.

| 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.5268 — Goldman Sachs/PAI/Xella International, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

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.5268 — Goldman Sachs/PAI/Xella International, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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

---

| 23.7.2008 | EN | Official Journal of the European Union | C 186/40 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/40

---

Prior notification of a concentration

(Case COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 186/15)

| 1. | On 3 July 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 Zurich Vida, Compañía de Seguros y Reaseguros, SA (‘Zurich Vida’, Spain) and Zurich España, Compañía de Seguros y Reaseguros, SA (‘Zurich Generales’, Spain) belonging to the Zurich Group (‘Zurich Group’, Switzerland) and Caixa d'Estalvis de Sabadell (‘Caixa Sabadell’, Spain) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of CaixaSabadell Vida, SA de Seguros y Reaseguros (‘Sabadell Vida’, Spain) and CaixaSabadell Compañía d'Assegurances Generals, SA (‘Sabadell Generales’, Spain), which are currently wholly-owned subsidiaries of Caixa Sabadell, by way of purchase of shares. |
| --- | --- |

1.

On 3 July 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 Zurich Vida, Compañía de Seguros y Reaseguros, SA (‘Zurich Vida’, Spain) and Zurich España, Compañía de Seguros y Reaseguros, SA (‘Zurich Generales’, Spain) belonging to the Zurich Group (‘Zurich Group’, Switzerland) and Caixa d'Estalvis de Sabadell (‘Caixa Sabadell’, Spain) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of CaixaSabadell Vida, SA de Seguros y Reaseguros (‘Sabadell Vida’, Spain) and CaixaSabadell Compañía d'Assegurances Generals, SA (‘Sabadell Generales’, Spain), which are currently wholly-owned subsidiaries of Caixa Sabadell, by way of purchase of shares.

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






  — | for Zurich Group: insurance, re-insurance, pensions and investment products in Europe, America and Asia, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Zurich Group: insurance, re-insurance, pensions and investment products in Europe, America and Asia,

| — | for Zurich Vida: Spanish subsidiary of the Zurich Group in the field of life insurance, |
| --- | --- |

—

for Zurich Vida: Spanish subsidiary of the Zurich Group in the field of life insurance,

| — | for Zurich Generales: Spanish subsidiary of the Zurich Group in the field of non-life insurance, |
| --- | --- |

—

for Zurich Generales: Spanish subsidiary of the Zurich Group in the field of non-life insurance,

| — | for Caixa Sabadell: savings bank mainly active in retail banking, |
| --- | --- |

—

for Caixa Sabadell: savings bank mainly active in retail banking,

| — | for Sabadell Vida: life insurance and pension products, |
| --- | --- |

—

for Sabadell Vida: life insurance and pension products,

| — | for Sabadell Generales: non-life insurance (home and accidents insurance). |
| --- | --- |

—

for Sabadell Generales: non-life insurance (home and accidents insurance).

| 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.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

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.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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

---

Corrigenda

| 23.7.2008 | EN | Official Journal of the European Union | C 186/41 |
| --- | --- | --- | --- |

23.7.2008

EN

Official Journal of the European Union

C 186/41

---

Corrigendum to notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism

(
  Official Journal of the European Union C 179 of 16 July 2008
  )

(2008/C 186/16)

On page 1, in the first paragraph:

for:

‘Council Decision 2008/584/EC’,

read:

‘Council Decision 2008/583/EC’.

---