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Document 52006XC0726(01)

Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Text with EEA relevance)

OJ C 173, 26.7.2006, p. 2–9 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

26.7.2006   

EN

Official Journal of the European Union

C 173/2


Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

(2006/C 173/02)

(Text with EEA relevance)

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

European Standardisation Organisation

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

Note 1

CEN/CENELEC

EN 46003:1999

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

NONE

-

CENELEC

EN 60118-13:1997

Hearing aids — Part 13: Electromagnetic compatibility (EMC)

(IEC 60118-13:1997)

NONE

-

CENELEC

EN 60118-13:2005

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

(IEC 60118-13:2004)

EN 60118-13:1997

Note 2.1

1.2.2008

CENELEC

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

(IEC 60522:1999)

NONE

-

CENELEC

EN 60580:2000

Medical electrical equipment — Dose area product meters

(IEC 60580:2000)

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)

CENELEC

EN 60601-1-1:2001

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

(IEC 60601-1-1:2000)

EN 60601-1-1:1993

+ A1:1996

Note 2.1

Date expired

(1.12.2003)

CENELEC

EN 60601-1-2:2001

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

(IEC 60601-1-2:2001)

EN 60601-1-2:1993

Note 2.1

Date expired

(1.11.2004)

CENELEC

EN 60601-1-3:1994

Medical electrical equipment — Part 1: General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:1994)

NONE

-

CENELEC

EN 60601-1-4:1996

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

(IEC 60601-1-4:1996)

NONE

-

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

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

Note 3

Date expired

(1.12.2002)

CENELEC

EN 60601-1-6:2004

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

(IEC 60601-1-6:2004)

NONE

-

CENELEC

EN 60601-2-1:1998

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

(IEC 60601-2-1:1998)

NONE

-

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

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

Note 3

Date expired

(1.6.2005)

CENELEC

EN 60601-2-2:2000

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

(IEC 60601-2-2:1998)

EN 60601-2-2:1993

Note 2.1

Date expired

(1.8.2003)

CENELEC

EN 60601-2-3:1993

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

(IEC 60601-2-3:1991)

NONE

-

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

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

Note 3

Date expired

(1.7.2001)

CENELEC

EN 60601-2-4:2003

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

(IEC 60601-2-4:2002)

NONE

-

CENELEC

EN 60601-2-5:2000

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

(IEC 60601-2-5:2000)

NONE

-

CENELEC

EN 60601-2-7:1998

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

(IEC 60601-2-7:1998)

NONE

-

CENELEC

EN 60601-2-8:1997

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

(IEC 60601-2-8:1987)

NONE

-

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

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

Note 3

Date expired

(1.6.1998)

CENELEC

EN 60601-2-9:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors

(IEC 60601-2-9:1996)

NONE

-

CENELEC

EN 60601-2-10:2000

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

(IEC 60601-2-10:1987)

NONE

-

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

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

Note 3

Date expired

(1.11.2004)

CENELEC

EN 60601-2-11:1997

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

(IEC 60601-2-11:1997)

NONE

-

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

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

Note 3

1.9.2007

CENELEC

EN 60601-2-16:1998

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

(IEC 60601-2-16:1998)

NONE

-

CENELEC

EN 60601-2-17:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment

(IEC 60601-2-17:1989)

NONE

-

Amendment A1:1996 to EN 60601-2-17:1996

(IEC 60601-2-17:1989/A1:1996)

Note 3

Date expired

(1.3.1997)

CENELEC

EN 60601-2-17:2004

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

(IEC 60601-2-17:2004)

EN 60601-2-17:1996

and its amendment

Note 2.1

1.3.2007

CENELEC

EN 60601-2-18:1996

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

(IEC 60601-2-18:1996)

NONE

-

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

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

Note 3

Date expired

(1.8.2003)

CENELEC

EN 60601-2-19:1996

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

(IEC 60601-2-19:1990)

NONE

-

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

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

Note 3

Date expired

(13.6.1998)

CENELEC

EN 60601-2-20:1996

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

(IEC 60601-2-20:1990 + A1:1996)

NONE

-

CENELEC

EN 60601-2-21:1994

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

(IEC 60601-2-21:1994)

NONE

-

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

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

Note 3

Date expired

(13.6.1998)

CENELEC

EN 60601-2-22:1996

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

(IEC 60601-2-22:1995)

NONE

-

CENELEC

EN 60601-2-23:2000

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

(IEC 60601-2-23:1999)

EN 60601-2-23:1997

Note 2.1

Date expired

(1.1.2003)

CENELEC

EN 60601-2-24:1998

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

(IEC 60601-2-24:1998)

NONE

-

CENELEC

EN 60601-2-25:1995

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

(IEC 60601-2-25:1993)

NONE

-

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

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

Note 3

Date expired

(1.5.2002)

CENELEC

EN 60601-2-26:2003

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

(IEC 60601-2-26:2002)

EN 60601-2-26:1994

Note 2.1

Date expired

(1.3.2006)

CENELEC

EN 60601-2-27:1994

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

(IEC 60601-2-27:1994)

NONE

-

CENELEC

EN 60601-2-27:2006

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

(IEC 60601-2-27:2005)

EN 60601-2-27:1994

Note 2.1

1.11.2008

CENELEC

EN 60601-2-28:1993

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

(IEC 60601-2-28:1993)

NONE

-

CENELEC

EN 60601-2-29:1999

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

(IEC 60601-2-29:1999)

EN 60601-2-29:1995

+ A1:1996

Note 2.1

Date expired

(1.4.2002)

CENELEC

EN 60601-2-30:2000

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

(IEC 60601-2-30:1999)

EN 60601-2-30:1995

Note 2.1

Date expired

(1.2.2003)

CENELEC

EN 60601-2-31:1995

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

(IEC 60601-2-31:1994)

NONE

-

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

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

Note 3

Date expired

(1.1.2001)

CENELEC

EN 60601-2-32:1994

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

(IEC 60601-2-32:1994)

NONE

-

CENELEC

EN 60601-2-33:2002

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

(IEC 60601-2-33:2002)

EN 60601-2-33:1995

+ A11:1997

Note 2.1

Date expired

(1.7.2005)

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

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

Note 3

1.11.2008

CENELEC

EN 60601-2-34:2000

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

(IEC 60601-2-34:2000)

EN 60601-2-34:1995

Note 2.1

Date expired

(1.11.2003)

CENELEC

EN 60601-2-35:1996

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

(IEC 60601-2-35:1996)

NONE

-

CENELEC

EN 60601-2-36:1997

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

(IEC 60601-2-36:1997)

NONE

-

CENELEC

EN 60601-2-37:2001

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

(IEC 60601-2-37:2001)

NONE

-

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

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

Note 3

1.1.2008

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

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

Note 3

1.12.2008

CENELEC

EN 60601-2-38:1996

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

(IEC 60601-2-38:1996)

NONE

-

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

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

Note 3

Date expired

(1.1.2003)

CENELEC

EN 60601-2-39:1999

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

(IEC 60601-2-39:1999)

NONE

-

CENELEC

EN 60601-2-40:1998

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

(IEC 60601-2-40:1998)

NONE

-

CENELEC

EN 60601-2-41:2000

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

(IEC 60601-2-41:2000)

NONE

-

CENELEC

EN 60601-2-43:2000

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

(IEC 60601-2-43:2000)

NONE

-

CENELEC

EN 60601-2-44:2001

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

(IEC 60601-2-44:2001)

EN 60601-2-44:1999

Note 2.1

Date expired

(1.7.2004)

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

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

Note 3

Date expired

(1.12.2005)

CENELEC

EN 60601-2-45:2001

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

(IEC 60601-2-45:2001)

EN 60601-2-45:1998

Note 2.1

Date expired

(1.7.2004)

CENELEC

EN 60601-2-46:1998

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

(IEC 60601-2-46:1998)

NONE

-

CENELEC

EN 60601-2-47:2001

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

(IEC 60601-2-47:2001)

NONE

-

CENELEC

EN 60601-2-49:2001

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

(IEC 60601-2-49:2001)

NONE

-

CENELEC

EN 60601-2-50:2002

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

(IEC 60601-2-50:2000)

NONE

-

CENELEC

EN 60601-2-51:2003

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

(IEC 60601-2-51:2003)

NONE

-

CENELEC

EN 60627:2001

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

(IEC 60627:2001)

NONE

-

CENELEC

EN 60645-1:2001

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

(IEC 60645-1:2001)

EN 60645-1:1994

Note 2.1

Date expired

(1.10.2004)

CENELEC

EN 60645-2:1997

Audiometers — Part 2: Equipment for speech audiometry

(IEC 60645-2:1993)

NONE

-

CENELEC

EN 60645-3:1995

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

(IEC 60645-3:1994)

NONE

-

CENELEC

EN 60645-4:1995

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

(IEC 60645-4:1994)

NONE

-

CENELEC

EN 61217:1996

Radiotherapy equipment — Coordinates, movements and scales

(IEC 61217:1996)

NONE

-

Amendment A1:2001 to EN 61217:1996

(IEC 61217:1996/A1:2000)

Note 3

Date expired

(1.12.2003)

CENELEC

EN 61223-3-1:1999

Evaluation and routine testing in medical imaging departments — Part 3-1: Acceptance tests — Imaging performance of X-ray equipment for radiographic and radioscopic systems

(IEC 61223-3-1:1999)

NONE

-

CENELEC

EN 61223-3-4:2000

Evaluation and routine testing in medical imaging departments — Part 3-4: Acceptance tests — Imaging performance of dental X-ray equipment

(IEC 61223-3-4:2000)

NONE

-

CENELEC

EN 61676:2002

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

(IEC 61676:2002)

NONE

-

CENELEC

EN 62083:2001

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

(IEC 62083:2000)

NONE

-

CENELEC

EN 62220-1:2004

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

(IEC 62220-1:2003)

NONE

-

Note 1:

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

Note 2.1:

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

Note 3:

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

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

CENELEC

EN 60601-1:1990

Medical electrical equipment --

Part 1: General requirements for safety

IEC 60601-1:1988

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

NONE

[There is no superseded standard]

-

Amendment A1:1993 to EN 60601-1:1990

IEC 60601-1:1988/A1:1991

[The referenced standard is EN 60601-1:1990

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

Note 3

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

-

Amendment A2:1995 to EN 60601-1:1990

IEC 60601-1:1988/A2:1995

[The referenced standard is EN 60601-1:1990

+A1:1993 to EN 60601-1:1990

+A2:1995 to EN60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990

+ A1:1993]

-

Amendment A13:1996 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

+ A1:1993 to EN 60601-1:1990

+ A2:1995 to EN 60601-1:1990

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

Note 3

[The superseded standard is EN 60601-1:1990

+ A1:1993

+ A2:1995]

Date expired

(1.7.1996)


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