Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Date: 2008-11-27
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, medical diagnosis

C 304/8

EN

Official Journal of the European Union

27.11.2008

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)

(2008/C 304/06)

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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Reference of the superseded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the superseded standard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 60118-13:2005
Electroacoustics — Hearing aids — Part 13: Electromagnetic compa-
tibility (EMC)
(IEC 60118-13:2004)

EN 60118-13:1997
Note 2.1

Date expired
(1.2.2008)

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

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

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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)

—

—

—

Note 3

Note 3

—

—

—

—

—

—

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EN 60601-1:2006
Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
(IEC 60601-1:2005)

EN 60601-1:1990
and its amendments
Note 2.1

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)

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

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EN 60601-1-2:2007
Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral standard: Electromagnetic
compatibility — Requirements and tests
(IEC 60601-1-2:2007 (Modified))

EN 60601-1-2:2001
and its amendment
Note 2.1

—

27.11.2008

EN

Official Journal of the European Union

C 304/9

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)

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EN 60601-1-3:1994
Medical electrical equipment — Part 1: General requirements for safety
— Collateral standard: General requirements for radiation protection in
diagnostic X-ray equipment
(IEC 60601-1-3:1994)

—

EN 60601-1-3:2008
Medical electrical equipment — Part 1-3: General requirements for basic
safety and essential performance — Collateral standard: Radiation protec-
tion in diagnostic X-ray equipment
(IEC 60601-1-3:2008)

EN 60601-1-3:1994
Note 2.1

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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)

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

—

Note 3

—

EN 60601-1-6:2007
Medical electrical equipment — Part 1-6: General requirements for basic
safety and essential performance — Collateral standard: Usability
(IEC 60601-1-6:2006)

EN 60601-1-6:2004
Note 2.1

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)

—

—

—

—

Date expired
(1.12.2002)

—

—

—

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

Note 3

Date expired
(1.1.2007)

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EN 60601-1-8:2007
Medical electrical equipment — Part 1-8: General requirements for basic
safety and essential performance — Collateral standard: General require-
ments, tests and guidance for alarm systems in medical electrical equip-
ment and medical electrical systems
(IEC 60601-1-8:2006)

EN 60601-1-8:2004
and its amendment

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EN 60601-1-10:2008
Medical electrical equipment — Part 1-10: General requirements for basic
safety and essential performance — Collateral standard: Requirements for
the development of physiologic closed-loop controllers
(IEC 60601-1-10:2007)

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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)

Note 3

Date expired
(1.6.2005)

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C 304/10

EN

Official Journal of the European Union

27.11.2008

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 60601-2-2:2000
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)

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

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)

—

—

Amendment A1:1998 to EN 60601-2-3:1993
(IEC 60601-2-3:1991/A1:1998)

Note 3

Date expired
(1.7.2001)

EN 60601-2-4:2003
Medical electrical equipment — Part 2-4: Particular requirements for the
safety of cardiac defibrillators
(IEC 60601-2-4:2002)

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)

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)

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)

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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)

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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)

—

—

—

—

Note 3

—

Note 3

—

Note 3

—

—

—

—

Date expired
(1.6.1998)

—

Date expired
(1.11.2004)

—

Date expired
(1.9.2007)

27.11.2008

EN

Official Journal of the European Union

C 304/11

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

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)

—

—
Note 2.3

—

—

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

Note 3

1.3.2010

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

—

—

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)

EN 60601-2-18:1996
Medical electrical equipment — Part 2: Particular requirements for the
safety of endoscopic equipment
(IEC 60601-2-18:1996)

—

—

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

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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)

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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)

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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)

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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)

Note 3

—

Note 3

—

—

Note 3

—

Date expired
(1.8.2003)

—

Date expired
(13.6.1998)

—

—

Date expired
(13.6.1998)

—

C 304/12

EN

Official Journal of the European Union

27.11.2008

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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 60601-2-23:1997
Note 2.1

Date expired
(1.1.2003)

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 60601-2-24:1998
Medical electrical equipment — Part 2-24: Particular requirements for the
safety of infusion pumps and controllers
(IEC 60601-2-24:1998)

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)

—

—

Note 3

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
(1.5.2002)

Date expired
(1.3.2006)

EN 60601-2-27:2006
Medical electrical equipment — Part 2-27: Particular requirements for the
safety,
including essential performance, of electrocardiographic moni-
toring equipment
(IEC 60601-2-27:2005)

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)

EN 60601-2-27:1994
Note 2.1

Date expired
(1.11.2008)

—

—

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)

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)

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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)

—

—

Amendment A1:1998 to EN 60601-2-31:1995
(IEC 60601-2-31:1994/A1:1998)

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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

—

Date expired
(1.1.2001)

—

27.11.2008

EN

Official Journal of the European Union

C 304/13

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Reference and title of the standard
(and reference document)

Reference of the superseded
standard

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)
+ Corrigendum 11.2008

EN 60601-2-33:1995
+ A11:1997
Note 2.1

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

Date expired
(1.7.2005)

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

Note 3

Date expired
(1.11.2008)

Amendment A2:2008 to EN 60601-2-33:2002
(IEC 60601-2-33:2002/A2:2007)

Note 3

1.2.2011

EN 60601-2-34:2000
Medical electrical equipment — Part 2-34: Particular requirements for the
safety, including essential performance, of invasive blood pressure moni-
toring equipment
(IEC 60601-2-34:2000)

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)

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)

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)

EN 60601-2-34:1995
Note 2.1

Date expired
(1.11.2003)

—

—

—

—

—

—

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

Note 3

Date expired
(1.1.2008)

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

Note 3

1.12.2008

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EN 60601-2-37:2008
Medical electrical equipment — Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment
(IEC 60601-2-37:2007)

EN 60601-2-37:2001
and its amendments
Note 2.1

1.10.2010

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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)

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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)

Note 3

—

Date expired
(1.1.2003)

—

C 304/14

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Official Journal of the European Union

27.11.2008

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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 60601-2-39:2008
Medical electrical equipment — Part 2-39: Particular requirements for
basic safety and essential performance of peritoneal dialysis equipment
(IEC 60601-2-39:2007)

EN 60601-2-39:1999
Note 2.1

1.3.2011

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)

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)

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)

—

—

—

—

—

—

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)

EN 60601-2-45:2001
Medical electrical equipment — Part 2-45: Particular requirements for the
safety of mammographic X-ray equipment and mammographic stereo-
tactic devices
(IEC 60601-2-45:2001)

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

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)

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)

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)

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)

Note 3

EN 60601-2-45:1998
Note 2.1

Date expired
(1.12.2005)

Date expired
(1.7.2004)

—

—

—

—

—

—

—

—

—

—

27.11.2008

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Official Journal of the European Union

C 304/15

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

—

—

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)

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

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

—

—

—

—

EN 60645-3:2007
Electroacoustics — Audiometric equipment — Part 3: Test signals of
short duration
(IEC 60645-3:2007)

EN 60645-3:1995
Note 2.1

1.6.2010

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

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

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

Amendment A2:2008 to EN 61217:1996
(IEC 61217:1996/A2:2007)

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EN 61676:2002
Medical
non-invasive measurement of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)

equipment — Dosimetric

instruments used for

electrical

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

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)

EN 62220-1-2:2007
Medical electrical equipment — Characteristics of digital X-ray imaging
devices — Part 1-2: Determination of the detective quantum efficiency —
Detectors used in mammography
(IEC 62220-1-2:2007)

—

—

Note 3

Note 3

—

—

—

—

—

—

Date expired
(1.12.2003)

1.2.2011

—

—

—

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Official Journal of the European Union

27.11.2008

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Reference and title of the standard
(and reference document)

Reference of the superseded
standard

EN 62304:2006
Medical device software — Software life-cycle processes
(IEC 62304:2006)

EN 62366:2008
Medical devices — Application of usability engineering to medical
devices
(IEC 62366:2007)

—

—

(1) ESO: European Standardisation Organisation:

— 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.eu),
— 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 of cessation of
presumption of conformity of
the superseded standard
(Note 1)

—

—

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.

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

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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 EN 60601-1:1990]

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]

—
[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)