Commission communication in the framework of the implementation of Council Directive 93/42/EEC
Date: 2004-06-24
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, occupational safety, technical standard

C 165/2

EN

Official Journal of the European Union

24.6.2004

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

(2004/C 165/02)

(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Reference of the superseded standard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superseded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 46003:1999

NONE

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

CENELEC

EN 60118-13:1997

IEC 60118-13:1997

NONE

Hearing aids — Part 13: Electromag-
netic compatibility (EMC)

CENELEC

EN 60522:1999

IEC 60522:1999

NONE

Determination of the permanent filtra-
tion of X-ray tube assemblies

CENELEC

EN 60580:2000

IEC 60580:2000

NONE

Medical electrical equipment
area product meters

- Dose

CENELEC

EN 60601-1:1990

IEC 60601-1:1988

NONE

Medical electrical equipment –Part 1:
General requirements for safety

Amendment A1:1993 to EN 60601-
1:1990

IEC 60601-1:1988

Note 3

/A1:1991

Amendment A2:1995 to EN 60601-
1:1990

IEC 60601-1:1988

Note 3

Amendment A13:1996 to EN 60601-
1:1990

Note 3

CENELEC

EN 60601-1-1:2001

IEC 60601-1-1:2000

EN 60601-1-1:1993

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

+A1:1996

—

—

—

—

—

—

—

Date expired
(01.07.1996)

Date expired
(01.12.2003)

24.6.2004

EN

Official Journal of the European Union

C 165/3

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-1-2:1993

IEC 60601-1-2:1993

NONE

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

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

CENELEC

EN 60601-1-2:2001

IEC 60601-1-2:2001

EN 60601-1-2:1993

01.11.2004

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

Note 2.1

CENELEC

EN 60601-1-3:1994

IEC 60601-1-3:1994

NONE

Medical electrical equipment – Part 1:
General requirements for safety — 3.
require-
Collateral standard: General
ments for radiation protection in diag-
nostic X-ray equipment

CENELEC

EN 60601-1-4:1996

IEC 60601-1-4:1996

NONE

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

standard:

—

—

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

IEC 60601-1-4:1996

Note 3

/A1:1999

Date expired
(01.12.2002)

CENELEC

EN 60601-2-1:1998

IEC 60601-2-1:1998

NONE

—

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

requirements

for

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

IEC 60601-2-1:1998

Note 3

01.06.2005

/A1:2002

CENELEC

EN 60601-2-2:2000

IEC 60601-2-2:1998

EN 60601-2-2:1993

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

Note 2.1

Date expired
(01.08.2003)

C 165/4

EN

Official Journal of the European Union

24.6.2004

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-2-3:1993

IEC 60601-2-3:1991

NONE

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

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

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

IEC 60601-2-3:1991

Note 3

/A1:1998

Date expired
(01.07.2001)

CENELEC

EN 60601-2-4:2003

IEC 60601-2-4:2002

NONE

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

for

CENELEC

EN 60601-2-5:2000

IEC 60601-2-5:2000

NONE

Medical electrical equipment – Part 2-
5: Particular
the
safety of ultrasonic physiotherapy
equipment

requirements

for

CENELEC

EN 60601-2-7:1998

IEC 60601-2-7:1998

NONE

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

requirements

for

CENELEC

EN 60601-2-8:1997

IEC 60601-2-8:1987

NONE

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

—

—

—

—

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

IEC 60601-2-8:1987

Note 3

/A1:1997

Date expired
(01.06.1998)

CENELEC

EN 60601-2-9:1996

IEC 60601-2-9:1996

NONE

—

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

24.6.2004

EN

Official Journal of the European Union

C 165/5

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-2-10:2000

IEC 60601-2-10:1987

NONE

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

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

requirements

for

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

IEC 60601-2-10:1987

Note 3

01.11.2004

/A1:2001

CENELEC

EN 60601-2-11:1997

IEC 60601-2-11:1997

NONE

Medical electrical equipment – Part 2-
11: Particular
the
safety of gamma beam therapy equip-
ment

requirements

for

CENELEC

EN 60601-2-16:1998

IEC 60601-2-16:1998

NONE

Medical electrical equipment – Part 2-
16: Particular
the
safety of haemodialysis, haemodiafil-
tration and haemofiltration equipment

requirements

for

CENELEC

EN 60601-2-17:1996

IEC 60601-2-17:1989

NONE

Medical electrical equipment – Part 2:
Particular requirements for the safety
automatically-
of
driven gamma-ray after-loading equip-
ment

remote-controlled

—

—

—

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

IEC 60601-2-17:1989

Note 3

/A1:1996

Date expired
(01.03.1997)

CENELEC

EN 60601-2-18:1996

IEC 60601-2-18:1996

NONE

—

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

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

IEC 60601-2-18:1996

Note 3

/A1:2000

Date expired
(01.08.2003)

CENELEC

EN 60601-2-19:1996

IEC 60601-2-19:1990

NONE

—

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

Note 3

/A1:1996

Date expired
(13.06.1998)

C 165/6

EN

Official Journal of the European Union

24.6.2004

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

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

IEC 60601-2-21:1994

NONE

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

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

—

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

IEC 60601-2-21:1994

Note 3

/A1:1996

Date expired
(13.06.1998)

CENELEC

EN 60601-2-22:1996

IEC 60601-2-22:1995

NONE

—

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

CENELEC

EN 60601-2-23:2000

IEC 60601-2-23:1999

EN 60601-2-23:1997

Medical electrical equipment – Part 2-
the
23: Particular
for
safety,
perfor-
mance, of transcutaneous partial pres-
sure monitoring equipment

requirements
essential

including

Note 2.1

CENELEC

EN 60601-2-24:1998

IEC 60601-2-24:1998

NONE

Medical electrical equipment – Part 2-
24: Particular
the
safety of infusion pumps and control-
lers

requirements

for

CENELEC

EN 60601-2-25:1995

IEC 60601-2-25:1993

NONE

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

for

Date expired
(01.01.2003)

—

—

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

IEC 60601-2-25:1993

Note 3

/A1:1999

Date expired
(01.05.2002)

CENELEC

EN 60601-2-26:1994

IEC 60601-2-26:1994

NONE

—

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

24.6.2004

EN

Official Journal of the European Union

C 165/7

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

CENELEC

EN 60601-2-26:2003

IEC 60601-2-26:2002

EN 60601-2-26:1994

01.03.2006

Medical electrical equipment – Part 2-
26: Particular
the
safety of electroencephalographs

requirements

for

Note 2.1

CENELEC

EN 60601-2-27:1994

IEC 60601-2-27:1994

NONE

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

CENELEC

EN 60601-2-28:1993

IEC 60601-2-28:1993

NONE

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

CENELEC

EN 60601-2-29:1999

IEC 60601-2-29:1999

EN 60601-2-29:1995

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

requirements

CENELEC

EN 60601-2-30:2000

IEC 60601-2-30:1999

EN 60601-2-30:1995

requirements
essential

Medical electrical equipment – Part 2-
30: Particular
the
for
perfor-
safety,
mance, of automatic cycling non-inva-
sive blood pressure monitoring equip-
ment

including

Note 2.1

—

—

Date expired
(01.04.2002)

Date expired
(01.02.2003)

CENELEC

EN 60601-2-31:1995

IEC 60601-2-31:1994

NONE

—

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

requirements

for

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

IEC 60601-2-31:1994

Note 3

/A1:1998

Date expired
(01.01.2001)

CENELEC

EN 60601-2-32:1994

IEC 60601-2-32:1994

NONE

—

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

C 165/8

EN

Official Journal of the European Union

24.6.2004

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-2-33:1995

IEC 60601-2-33:1995

NONE

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

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

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

Note 3

Date expired
(13.06.1998)

CENELEC

EN 60601-2-33:2002

IEC 60601-2-33:2002

EN 60601-2-33:1995

01.07.2005

Medical electrical equipment – Part 2-
33: Particular
the
safety of magnetic resonance equip-
ment for medical diagnosis

requirements

for

and its amendment

CENELEC

EN 60601-2-34:2000

IEC 60601-2-34:2000

EN 60601-2-34:1995

Medical electrical equipment – Part 2-
for
34: Particular
the
requirements
essential
safety,
perfor-
mance, of
invasive blood pressure
monitoring equipment

including

Note 2.1

Date expired
(01.11.2003)

CENELEC

EN 60601-2-35:1996

IEC 60601-2-35:1996

NONE

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

CENELEC

EN 60601-2-36:1997

IEC 60601-2-36:1997

NONE

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

CENELEC

EN 60601-2-37:2001

IEC 60601-2-37:2001

NONE

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

requirements

for

CENELEC

EN 60601-2-38:1996

IEC 60601-2-38:1996

NONE

—

—

—

—

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

requirements

for

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

IEC 60601-2-38:1996

Note 3

/A1:1999

Date expired
(01.01.2003)

24.6.2004

EN

Official Journal of the European Union

C 165/9

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-2-39:1999

IEC 60601-2-39:1999

NONE

Medical electrical equipment – Part 2-
39: Particular
the
safety of peritoneal dialysis equipment

requirements

for

CENELEC

EN 60601-2-40:1998

IEC 60601-2-40:1998

NONE

Medical electrical equipment – Part 2-
the
40: Particular
safety
and
evoked response equipment

requirements
electromyographs

for

of

CENELEC

EN 60601-2-41:2000

IEC 60601-2-41:2000

NONE

Medical electrical equipment – Part 2-
the
41: Particular
safety of surgical luminaires and lumi-
naires for diagnosis

requirements

for

CENELEC

EN 60601-2-43:2000

IEC 60601-2-43:2000

NONE

Medical electrical equipment – Part 2-
43: Particular
the
safety of X-ray equipment for inter-
ventional procedures

requirements

for

CENELEC

EN 60601-2-44:1999

IEC 60601-2-44:1999

NONE

Medical electrical equipment – Part 2-
the
44: Particular
safety
for
computed tomography

for
equipment

requirements

X-ray

of

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

—

—

—

—

CENELEC

EN 60601-2-44:2001

IEC 60601-2-44:2001

EN 60601-2-44:1999

01.07.2004

Medical electrical equipment – Part 2-
the
44: Particular
safety
for
computed tomography

for
equipment

requirements

X-ray

of

Note 2.1

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

IEC 60601-2-44:2001

Note 3

01.12.2005

/A1:2002

CENELEC

EN 60601-2-45:1998

IEC 60601-2-45:1998

NONE

—

requirements

Medical electrical equipment – Part 2-
the
45: Particular
safety of mammographic X-ray equip-
ment and mammographic stereotactic
devices

for

CENELEC

EN 60601-2-45:2001

IEC 60601-2-45:2001

EN 60601-2-45:1998

01.07.2004

requirements

Medical electrical equipment – Part 2-
45: Particular
the
safety of mammographic X-ray equip-
ment and mammographic stereotactic
devices

for

Note 2.1

C 165/10

EN

Official Journal of the European Union

24.6.2004

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

CENELEC

EN 60601-2-46:1998

IEC 60601-2-46:1998

NONE

Medical electrical equipment – Part 2-
46: Particular
the
safety of operating tables

requirements

for

CENELEC

EN 60601-2-47:2001

IEC 60601-2-47:2001

NONE

Medical electrical equipment – Part 2-
the
47: Particular
for
safety,
perfor-
mance, of ambulatory electrocardio-
graphic systems

requirements
essential

including

CENELEC

EN 60601-2-49:2001

IEC 60601-2-49:2001

NONE

Medical electrical equipment – Part 2-
49: Particular
the
safety of multifunction patient moni-
toring equipment

requirements

for

CENELEC

EN 60601-2-50:2002

IEC 60601-2-50:2000

NONE

Medical electrical equipment – Part 2-
50: Particular
the
safety of infant phototherapy equip-
ment

requirements

for

CENELEC

EN 60601-2-51:2003

IEC 60601-2-51:2003

NONE

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

CENELEC

EN 60627:2001

IEC 60627:2001

NONE

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

CENELEC

EN 60645-1:1994

IEC 60645-1:1992

NONE

Audiometers
audiometers

–

Part 1:

Pure-tone

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

—

—

—

—

—

—

—

24.6.2004

EN

Official Journal of the European Union

C 165/11

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

CENELEC

EN 60645-1:2001

IEC 60645-1:2001

EN 60645-1:1994

01.10.2004

Electroacoustics - Audiological equip-
ment – Part 1: Pure-tone audiometers

Note 2.1

CENELEC

EN 60645-2:1997

IEC 60645-2:1993

NONE

Audiometers – Part 2: Equipment for
speech audiometry

CENELEC

EN 60645-3:1995

IEC 60645-3:1994

NONE

Audiometers – Part 3: Auditory test
signals of short duration for audio-
metric and neuro-otological purposes

CENELEC

EN 60645-4:1995

IEC 60645-4:1994

NONE

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

CENELEC

EN 61217:1996

IEC 61217:1996

NONE

Radiotherapy equipment
nates, movements and scales

- Coordi-

—

—

—

—

Amendment
61217:1996

A1:2001

to

EN

IEC 61217:1996

Note 3

/A1:2000

Date expired
(01.12.2003)

CENELEC

EN 61223-3-1:1999

IEC 61223-3-1:1999

NONE

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

CENELEC

EN 61223-3-4:2000

IEC 61223-3-4:2000

NONE

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

—

—

C 165/12

EN

Official Journal of the European Union

24.6.2004

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

CENELEC

EN 61676:2002

IEC 61676:2002

NONE

Medical electrical equipment - Dosi-
metric instruments used for non-inva-
sive measurement of X-ray
tube
voltage in diagnostic radiology

CENELEC

EN 62083:2001

IEC 62083:2000

NONE

electrical

Medical
–
Requirements for the safety of radio-
therapy treatment planning systems

equipment

CENELEC

EN 62220-1:2004

IEC 62220-1:2003

NONE

Medical electrical equipment - Charac-
teristics of digital X-ray
imaging
devices – Part 1: Determination of the
detective quantum efficiency

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

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

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 stan-
dards 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 amend-
ment. 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
1:1990]

referenced standard is EN 60601-

Amendment A1:1993 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+A1:1993 to 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]

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]

IEC 60601-1:1988

NONE
[There is no superseded standard]

IEC 60601-1:1988
/A1:1991

IEC 60601-1:1988
/A2:1995

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

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

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

standard

is

standard

is

standard

is

Date expired
(01.07.1996)

—

—

—

—

—

—