# C_2004176EN.01000301.xml

| 8.7.2004 | EN | Official Journal of the European Union | C 176/3 |
| --- | --- | --- | --- |

8.7.2004

EN

Official Journal of the European Union

C 176/3

---

Commission communication in the framework of the implementation of Council Directive 90/385/EEC

(Text with EEA relevance)

Publication of titles and references of harmonized standards under the directive

| European Standardisation Organisation  (1) | Reference and title of the standard | Reference document | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| CEN/CENELEC | EN 45502-1:1997
  Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer | | NONE | — |
| CEN/CENELEC | EN 45502-2-1:2003
  Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | | NONE | — |
| CEN/CENELEC | EN 46003:1999
  Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 | | NONE | — |
| CENELEC | EN 60601-1:1990
  Medical electrical equipment -- Part 1: General requirements for safety | IEC 60601-1:1988 | NONE | — |
| Amendment A1:1993 to EN 60601-1:1990 | IEC 60601-1:1988
  /A1:1991 | Note 3 | — |
| Amendment A2:1995 to EN 60601-1:1990 | IEC 60601-1:1988
  /A2:1995 | Note 3 | — |
| Amendment A13:1996 to EN 60601-1:1990 | | Note 3 | Date expired (1.7.1996) |

European Standardisation Organisation  (1)

1

Reference and title of the standard

Reference document

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

Note 1

CEN/CENELEC

EN 45502-1:1997

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

NONE

—

CEN/CENELEC

EN 45502-2-1:2003

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

NONE

—

CEN/CENELEC

EN 46003:1999

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

NONE

—

CENELEC

EN 60601-1:1990

Medical electrical equipment -- Part 1: General requirements for safety

IEC 60601-1:1988

NONE

—

Amendment A1:1993 to EN 60601-1:1990

IEC 60601-1:1988

/A1:1991

Note 3

—

Amendment A2:1995 to EN 60601-1:1990

IEC 60601-1:1988

/A2:1995

Note 3

—

Amendment A13:1996 to EN 60601-1:1990

Note 3

Date expired (1.7.1996)

| 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 4) 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 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 4) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

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

Example:

| CENELEC | EN 60601-1:1990
  Medical electrical equipment -- Part 1: General requirements for safety
  [The referenced standard is EN 60601-1:1990] | IEC 60601-1:1988 | NONE
  [There is no superseded standard] | — |
| --- | --- | --- | --- | --- |
| Amendment A1:1993 to EN 60601-1:1990
  [The referenced standard is EN 60601-1:1990
  +A1:1993 to EN 60601-1:1990] | IEC 60601-1:1988
  /A1:1991 | Note 3
  [The superseded standard is EN 60601-1:1990] | — |
| Amendment A2:1995 to EN 60601-1:1990
  [The referenced standard is EN 60601-1:1990
  +A1:1993 to EN 60601-1:1990
  +A2:1995 to EN60601-1:1990] | IEC 60601-1:1988
  /A2:1995 | Note 3
  [The superseded standard is EN 60601-1:1990
  - A1:1993] | — |
| Amendment A13:1996 to EN 60601-1:1990
  [The referenced standard is EN 60601-1:1990
  - A1:1993 to EN 60601-1:1990
  - A2:1995 to EN 60601-1:1990
  - A13:1996 to EN 60601-1:1990] | | Note 3
  [The superseded standard is EN 60601-1:1990
  - A1:1993
  - A2:1995] | Date expired (1.7.1996) |

CENELEC

EN 60601-1:1990

Medical electrical equipment -- Part 1: General requirements for safety

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

IEC 60601-1:1988

NONE

[There is no superseded standard]

—

Amendment A1:1993 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

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

IEC 60601-1:1988

/A1:1991

Note 3

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

—

Amendment A2:1995 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

+A1:1993 to EN 60601-1:1990

+A2:1995 to EN60601-1:1990]

IEC 60601-1:1988

/A2:1995

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993]

—

Amendment A13:1996 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

- A1:1993 to EN 60601-1:1990

- A2:1995 to EN 60601-1:1990

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

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993

- A2:1995]

Date expired (1.7.1996)

---

(1)  CEN: rue de Stassart/De Stassartstraat 36, B—1050 Brussels, tel.: (32-2) 550 08 11, fax: (32-2) 550 08 19;

1

CENELEC: rue de Stassart/De Stassartstraat 35, B—1050 Brussels, tel.: (32-2) 519 68 71, fax: (32-2) 519 69 19;

ETSI: BP 152, F—06561 Valbonne Cedex, tel.: (33) 492 94 42 12, fax: (33) 493 65 47 16.

---