Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance )
Date: 2007-12-22
Institutions: European Commission
Subjects: Cenelec, European standard, harmonisation of standards, medical device

C 314/28

EN

Official Journal of the European Union

22.12.2007

NOTICES FROM MEMBER STATES

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

(Text with EEA relevance)

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

(2007/C 314/09)

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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Reference of the superseded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of the superseded standard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)

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)

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)

Amendment A13:1996 to EN 60601-1:1990

NONE

NONE

NONE

Note 3

Note 3

Note 3

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
(1.7.1996)

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)

Amendment A1:2006 to EN 60601-1-2:2001
(IEC 60601-1-2:2001/A1:2004)

1.3.2009

22.12.2007

EN

Official Journal of the European Union

C 314/29

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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)

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

CENELEC

EN 60601-1-6:2004
Medical electrical equipment — Part 1-6: General requirements for safety —
Collateral standard: Usability
(IEC 60601-1-6:2004)

CENELEC

EN 60601-1-8:2004
Medical electrical equipment — Part 1-8: General requirements for safety —
Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
(IEC 60601-1-8:2003)

Amendment A1:2006 to EN 60601-1-8:2004
(IEC 60601-1-8:2003/A1:2006)

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)

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

NONE

NONE

Note 3

NONE

NONE

Note 3

NONE

Note 3

—

—

Date expired
(1.12.2002)

—

—

Date expired
(1.1.2007)

—

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 60601-2-2:2007
Medical electrical equipment — Part 2-2: Particular requirements for the safety of
high frequency surgical equipment
(IEC 60601-2-2:2006)

EN 60601-2-2:2000
Note 2.1

1.10.2009

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)

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)

Note 3

NONE

NONE

Date expired
(1.7.2001)

—

—

C 314/30

EN

Official Journal of the European Union

22.12.2007

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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)

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)

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

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)

Amendment A1:2001 to EN 60601-2-10:2000
(IEC 60601-2-10:1987/A1:2001)

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)

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

CENELEC

EN 60601-2-12:2006
Medical electrical equipment — Part 2-12: Particular requirements for the safety
of lung ventilators — Critical care ventilators
(IEC 60601-2-12:2001)

NONE

NONE

Note 3

NONE

Note 3

NONE

Note 3

NONE

CENELEC

EN 60601-2-13:2006
Medical electrical equipment — Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
(IEC 60601-2-13:2003)

EN 740:1998
+ A1:2004
+ AC:1998
Note 2.3

Amendment A1:2007 to EN 60601-2-13:2006
(IEC 60601-2-13:2003/A1:2006)

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)

Note 3

NONE

—

—

Date expired
(1.6.1998)

—

Date expired
(1.11.2004)

—

Date expired
(1.9.2007)

—

—

1.3.2010

—

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
+ A1:1996
Note 2.1

Date expired
(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)

CENELEC

EN 60601-2-19:1996
Medical electrical equipment — Part 2: Particular requirements for the safety of
baby incubators
(IEC 60601-2-19:1990)

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

Note 3

NONE

Note 3

Date expired
(1.8.2003)

—

Date expired
(13.6.1998)

22.12.2007

EN

Official Journal of the European Union

C 314/31

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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)

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

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

NONE

Note 3

NONE

—

—

Date expired
(13.6.1998)

—

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)

Amendment A1:1999 to EN 60601-2-25:1995
(IEC 60601-2-25:1993/A1:1999)

NONE

NONE

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)

C 314/32

EN

Official Journal of the European Union

22.12.2007

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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 pres-
sure 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)

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)

Note 3

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
(1.1.2001)

—

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 equip-
ment
(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)

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)

Amendment A1:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A1:2004)

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

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)

Amendment A1:2000 to EN 60601-2-38:1996
(IEC 60601-2-38:1996/A1:1999)

NONE

NONE

NONE

Note 3

Note 3

NONE

Note 3

—

—

—

1.1.2008

1.12.2008

—

Date expired
(1.1.2003)

22.12.2007

EN

Official Journal of the European Union

C 314/33

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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

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)

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)

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

—

—

—

—

—

—

C 314/34

EN

Official Journal of the European Union

22.12.2007

European
Standardisa-
tion Organi-
sation (1)

CENELEC

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)

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)

CENELEC

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

CENELEC

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

CENELEC

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

Amendment A1:2001 to EN 61217:1996
(IEC 61217:1996/A1:2000)

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 radiotherapy treat-
ment 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

Note 3

NONE

NONE

NONE

(1) CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, Tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be)

CENELEC: rue de Stassart/De Stassartstraat 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, Tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org).

—

—

—

—

Date expired
(1.12.2003)

—

—

—

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 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the
(partially) superseded standard ceases to give presumption of conformity with the essential
requirements of the directive for those products that fall within the scope of the new standard.
Presumption of conformity with the essential requirements of the directive for products that still
fall within the scope of the (partially) superseded standard, but that do not fall within the scope
of the new standard, is unaffected.

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.

22.12.2007

EN

Official Journal of the European Union

C 314/35

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]

NONE
[There is no superseded standard]

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)