Commission communication in the framework of the implementation of Council Directive 93/42/EEC (Text with EEA relevance)
Date: 2005-04-28
Institutions: European Commission
Subjects: European standard, medical device, technical standard

C 103/2

EN

Official Journal of the European Union

28.4.2005

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

(2005/C 103/02)

(Text with EEA relevance)

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

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

European
Standard-
isation Orga-
nisation

CEN/
CENELEC

EN 46003:1999
Quality systems — Medical devices — Particular requirements for the
application of EN ISO 9003

CENELEC

EN 60118-13:1997
Hearing aids — Part 13: Electromagnetic compatibility (EMC)
(IEC 60118-13:1997)

CENELEC

EN 60522:1999
Determination of the permanent filtration of X-ray tube assemblies
(IEC 60522:1999)

CENELEC

EN 60580:2000
Medical electrical equipment — Dose area product meters
(IEC 60580:2000)

CENELEC

EN 60601-1:1990
Medical electrical equipment — Part 1: General requirements for safety
(IEC 60601-1:1988)

Amendment A1:1993 to EN 60601-1:1990
(IEC 60601-1:1988/A1:1991)

Amendment A2:1995 to EN 60601-1:1990
(IEC 60601-1:1988/A2:1995)

None

None

None

None

None

Note 3

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 — Require-
ments and tests
(IEC 60601-1-2:2001)

EN 60601-1-2:1993
Note 2.1

Date expired (1.11.2004)

28.4.2005

EN

Official Journal of the European Union

C 103/3

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

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)

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

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 60601-2-1:1998
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

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)

CENELEC

EN 60601-2-5:2000
Medical electrical equipment — Part 2-5: Particular requirements for the
safety of ultrasonic physiotherapy equipment
(IEC 60601-2-5:2000)

CENELEC

EN 60601-2-7:1998
Medical electrical equipment — Part 2-7: Particular requirements for the
safety of high-voltage generators of diagnostic X-ray generators
(IEC 60601-2-7:1998)

None

None

None

—

—

—

C 103/4

EN

Official Journal of the European Union

28.4.2005

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

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 electri-
cally connected radiation detectors
(IEC 60601-2-9:1996)

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

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)

CENELEC

EN 60601-2-16:1998
Medical electrical equipment — Part 2-16: Particular requirements for
the safety of haemodialysis, haemodiafiltration and haemofiltration
equipment
(IEC 60601-2-16:1998)

CENELEC

EN 60601-2-17:1996
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

None

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 equip-
ment
(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)

28.4.2005

EN

Official Journal of the European Union

C 103/5

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

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)

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

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)

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

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 60601-2-26:1994
Medical electrical equipment — Part 2: Particular requirements for the
safety of electroencephalographs
(IEC 60601-2-26:1994)

None

—

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

1.3.2006

C 103/6

EN

Official Journal of the European Union

28.4.2005

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

EN 60601-2-27:1994
Medical electrical equipment — Part 2: Particular requirements for the
safety of electrocardiographic monitoring equipment
(IEC 60601-2-27:1994)

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

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)

CENELEC

EN 60601-2-33:1995
Medical electrical equipment — Part 2: Particular requirements for the
safety of magnetic resonance equipment for medical diagnosis
(IEC 60601-2-33:1995)

None

None

—

—

Amendment A11:1997 to EN 60601-2-33:1995

Note 3

Date expired (13.6.1998)

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 and
its amendment
Note 2.1

1.7.2005

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)

28.4.2005

EN

Official Journal of the European Union

C 103/7

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

European
Standard-
isation Orga-
nisation

CENELEC

EN 60601-2-35:1996
Medical electrical equipment — Part 2: Particular requirements for the
safety of blankets, pads and mattresses, intended for heating in medical
use
(IEC 60601-2-35:1996)

CENELEC

EN 60601-2-36:1997
Medical electrical equipment — Part 2: Particular requirements for the
safety of equipment for extracorporeally induced lithotripsy
(IEC 60601-2-36:1997)

CENELEC

EN 60601-2-37:2001
Medical electrical equipment — Part 2-37: Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment
(IEC 60601-2-37:2001)

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

None

None

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)

CENELEC

EN 60601-2-40:1998
Medical electrical equipment — Part 2-40: Particular requirements for
the safety of electromyographs and evoked response equipment
(IEC 60601-2-40:1998)

CENELEC

EN 60601-2-41:2000
Medical electrical equipment — Part 2-41: Particular requirements for
the safety of surgical luminaires and luminaires for diagnosis
(IEC 60601-2-41:2000)

CENELEC

EN 60601-2-43:2000
Medical electrical equipment — Part 2-43: Particular requirements for
the safety of X-ray equipment for interventional procedures
(IEC 60601-2-43:2000)

None

None

None

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

1.12.2005

C 103/8

EN

Official Journal of the European Union

28.4.2005

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

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 of cessation of presump-
tion of conformity of the
superseded standard
Note 1

Date expired (1.7.2004)

CENELEC

EN 60601-2-46:1998
Medical electrical equipment — Part 2-46: Particular requirements for
the safety of operating tables
(IEC 60601-2-46:1998)

CENELEC

EN 60601-2-47:2001
Medical electrical equipment — Part 2-47: Particular requirements for
the safety, including essential performance, of ambulatory electrocardio-
graphic systems
(IEC 60601-2-47:2001)

CENELEC

EN 60601-2-49:2001
Medical electrical equipment — Part 2-49: Particular requirements for
the safety of multifunction patient monitoring equipment
(IEC 60601-2-49:2001)

CENELEC

EN 60601-2-50:2002
Medical electrical equipment — Part 2-50: Particular requirements for
the safety of infant phototherapy equipment
(IEC 60601-2-50:2000)

CENELEC

EN 60601-2-51:2003
Medical electrical equipment — Part 2-51: Particular requirements for
safety, including essential performance, of recording and analysing single
channel and multichannel electrocardiographs
(IEC 60601-2-51:2003)

CENELEC

EN 60627:2001
Diagnostic X-ray imaging equipment — Characteristics of general
purpose and mammographic anti-scatter grids
(IEC 60627:2001)

None

None

None

None

None

None

—

—

—

—

—

—

CENELEC

EN 60645-1:2001
Electroacoustics — Audiological equipment — Part 1: Pure-tone audio-
meters
(IEC 60645-1:2001)

EN 60645-1:1994
Note 2.1

Date expired (1.10.2004)

CENELEC

EN 60645-2:1997
Audiometers — Part 2: Equipment for speech audiometry
(IEC 60645-2:1993)

CENELEC

EN 60645-3:1995
Audiometers — Part 3: Auditory test signals of short duration for audio-
metric and neuro-otological purposes
(IEC 60645-3:1994)

None

None

—

—

28.4.2005

EN

Official Journal of the European Union

C 103/9

European
Standard-
isation Orga-
nisation

CENELEC

Reference and title of the standard
(and reference document)

Reference of the superseded
standard

Date of cessation of presump-
tion of conformity of the
superseded standard
Note 1

EN 60645-4:1995
Audiometers — Part 4: Equipment for extended high-frequency audio-
metry
(IEC 60645-4:1994)

CENELEC

EN 61217:1996
Radiotherapy equipment — Coordinates, movements and scales
(IEC 61217:1996)

None

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)

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 equip-
ment
(IEC 61223-3-4:2000)

CENELEC

EN 61676:2002
Medical electrical equipment — Dosimetric instruments used for non-
invasive measurement of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)

CENELEC

EN 62083:2001
Medical electrical equipment — Requirements for the safety of radio-
therapy treatment planning systems
(IEC 62083:2000)

CENELEC

EN 62220-1:2004
Medical electrical equipment — Characteristics of digital X-ray imaging
devices — Part 1: Determination of the detective quantum efficiency
(IEC 62220-1:2003)

None

None

None

None

None

—

—

—

—

—

Note 1:

Note 2.1:

Note 3:

Generally the date of cessation of presumption of conformity will be the date of with-
drawal (‘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.

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.

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amend-
ments, 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.

C 103/10

EN

Official Journal of the European Union

28.4.2005

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]

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]

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]

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]

—

—

—

Date expired (1.7.1996)

None
[There is no superseded stand-
ard]

Note 3
[The superseded standard is
EN 60601-1:1990]

Note 3
[The superseded standard
is EN 60601-1:1990
+ A1:1993]

Note 3
[The superseded standard
is EN 60601-1:1990
+ A1:1993
+ A2:1995]