Commission communication in the framework of the implementation of the Council directive 93/42/EEC (Text with EEA relevance)
Date: 2003-10-15
Institutions: European Commission
Subjects: harmonisation of standards, medical device, occupational safety, public health

15.10.2003

EN

Official Journal of the European Union

C 247/7

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

(2003/C 247/04)

(Text with EEA relevance)

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

ESO (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superseded standard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of the superseded standard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 46001:1996

Quality systems — Medical devices — Particular
requirements for the application of EN ISO 9001

CEN/Cenelec

EN 46002:1996

Quality systems — Medical devices — Particular
requirements for the application of EN ISO 9002

CEN/Cenelec

EN 46003:1999

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

Cenelec

EN 50103:1995

Guidance on the application of EN 29001 and EN
46001 and of EN 29002 and EN 46002 for the
active (including active implantable) medical device
industry

Cenelec

EN 60118-13:1997

None

None

None

None

Hearing aids — Part 13: Electromagnetic compati-
bility (EMC)

IEC 60118-13:1997

None

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

Amendment A2:1995 to EN 60601-1:1990

Amendment A13:1996 to EN 60601-1:1990

IEC 60601-1:1988
/A1:1991

IEC 60601-1:1988
/A2:1995

Note 3

Note 3

Note 3

—

—

—

—

—

—

—

—

—

—

Date expired
(1.7.1996)

Cenelec

EN 60601-1-1:1993

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

Amendment A1:1996 to EN 60601-1-1:1993

IEC 60601-1-1:1992

None

—

IEC 60601-1-1:1992
/A1:1995

Note 3

Date expired
(1.9.1996)

C 247/8

EN

Official Journal of the European Union

15.10.2003

ESO (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superseded standard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

Cenelec

EN 60601-1-1:2001

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

safety — Collateral

for

IEC 60601-1-1:2000

EN 60601-1-1:1993
and its amendment
Note 2.1

1.12.2003

Cenelec

EN 60601-1-2:1993

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

IEC 60601-1-2:1993

None

—

Cenelec

EN 60601-1-2:2001

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

IEC 60601-1-2:2001

EN 60601-1-2:1993
Note 2.1

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 diag-
nostic X-ray equipment

IEC 60601-1-3:1994

None

Cenelec

EN 60601-1-4:1996

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

safety — Collateral

for

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 60601-2-1:1998

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

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

IEC 60601-2-1:1998

None

—

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

Note 3

1.6.2005

Cenelec

EN 60601-2-2:1993

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

the

IEC 60601-2-2:1991

None

—

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

1.8.2003

Cenelec

EN 60601-2-3:1993

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

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

Cenelec

EN 60601-2-4:2003

IEC 60601-2-3:1991

None

—

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

Note 3

Date expired
(1.7.2001)

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

IEC 60601-2-4:2002

None

—

15.10.2003

EN

Official Journal of the European Union

C 247/9

ESO (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

Cenelec

EN 60601-2-5:2000

Medical electrical equipment — Part 2-5: Particular
requirements for
the safety of ultrasonic physio-
therapy 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
therapeutic X-ray
the safety of
requirements
equipment operating in the range 10 kV to 1 MV

for

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
contact
dosemeters used in radiotherapy with electrically
connected radiation detectors

safety of patient

the

for

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

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

Cenelec

EN 60601-2-16:1998

Medical electrical equipment — Part 2-16: Particular
requirements for the safety of haemodialysis, haemo-
diafiltration 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 auto-
matically-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 60601-2-18:1996

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

—

1.8.2003

C 247/10

EN

Official Journal of the European Union

15.10.2003

ESO (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

Cenelec

EN 60601-2-19:1996

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

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

IEC 60601-2-19:1990

None

—

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 thera-
peutic laser equipment

IEC 60601-2-22:1995

None

—

Cenelec

EN 60601-2-23:2000

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

safety,

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 60601-2-26:1994

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

IEC 60601-2-26:1994

None

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 60601-2-28:1993

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)

15.10.2003

EN

Official Journal of the European Union

C 247/11

ESO (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

Cenelec

EN 60601-2-30:2000

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

the
automatic

safety,

Cenelec

EN 60601-2-31:1995

Medical electrical equipment — Part 2-31: Particular
requirements
cardiac
pacemakers with internal power source

safety of

external

the

for

IEC 60601-2-30:1999

EN 60601-2-30:1995
Note 2.1

Date expired
(1.2.2003)

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 60601-2-33:1995

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

IEC 60601-2-33:1995

None

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

Note 3

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

—

—

Date expired
(13.6.1998)

1.7.2005

Cenelec

EN 60601-2-34:1995

Medical electrical equipment — Part 2: Particular
requirements for the safety of direct blood pressure
monitoring equipment

IEC 60601-2-34:1994

None

—

Cenelec

EN 60601-2-34:2000

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

safety,

the

for

IEC 60601-2-34:2000

EN 60601-2-34:1995
Note 2.1

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 extra-
corporeally 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

—

—

—

C 247/12

EN

Official Journal of the European Union

15.10.2003

ESO (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

Cenelec

EN 60601-2-38:1996

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

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

IEC 60601-2-38:1996

None

—

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
the safety of peritoneal dialysis
requirements for
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 60601-2-44:1999

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

IEC 60601-2-44:1999

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

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

IEC 60601-2-44:2001

EN 60601-2-44:1999
Note 2.1

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

Note 3

1.7.2004

1.12.2005

Cenelec

EN 60601-2-45:1998

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

Cenelec

EN 60601-2-45:2001

IEC 60601-2-45:1998

None

—

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

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
including essential
requirements
for
performance, of
electrocardiographic
systems

the
safety,
ambulatory

IEC 60601-2-47:2001

None

—

—

15.10.2003

EN

Official Journal of the European Union

C 247/13

ESO (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

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 60627:2001

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

IEC 60627:2001

None

Cenelec

EN 60645-1:1994

Audiometers — Part 1: Pure-tone audiometers

IEC 60645-1:1992

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

1.10.2004

Cenelec

EN 60645-2:1997

Audiometers — Part 2: Equipment
audiometry

for

speech

IEC 60645-2:1993

None

Cenelec

EN 60645-3:1995

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

audiometric

and

for

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

1.12.2003

Cenelec

EN 61223-3-1:1999

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

IEC 61223-3-1:1999

None

Cenelec

EN 61223-3-4:2000

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

imaging
tests —

IEC 61223-3-4:2000

None

Cenelec

EN 61676:2002

electrical

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

IEC 61676:2002

None

—

—

—

C 247/14

EN

Official Journal of the European Union

15.10.2003

ESO (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

Cenelec

EN 62083:2001

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

IEC 62083:2000

None

—

(1) ESO (European standardisation organisations):

— CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be)
— 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 Cedex, tel. (33-4) 92 94 42 00, fax (33-4) 93 65 47 16 (http://www.etsi.org).

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 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:

Cenelec

EN 60601-1:1990

Medical electrical equipment —
Part 1: General requirements for safety
(The referenced standard is EN 60601-1:1990)

Amendment A1:1993 to EN 60601-1:1990
standard
(The
+A1:1993 to EN 60601-1:1990)

referenced

is

EN 60601-1:1990

referenced

Amendment A2:1995 to EN 60601-1:1990
(The
standard
+A1:1993 to EN 60601-1:1990
+A2:1995 to EN60601-1:1990)

is

EN 60601-1:1990

referenced

Amendment A13:1996 to EN 60601-1:1990
(The
standard
+A1:1993 to EN 60601-1:1990
+A2:1995 to EN 60601-1:1990
+A13:1996 to EN 60601-1:1990)

is

EN 60601-1:1990

IEC 60601-1:1988

IEC 60601-1:1988
/A1:1991

IEC 60601-1:1988
/A2:1995

None
(There
standard)

is no superseded

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)

—

—

—

Date expired
(1.7.1996)