C 16/8 EN Official Journal of the European Union 18.1.

2011

Commission communication in the framework of the implementation of the Council Directive

93/42/EEC of 14 June 1993 concerning medical devices
(Text with EEA relevance)

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

(2011/C 16/02)

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 285:2006+A2:2009 2.12.2009 EN 285:2006+A1:2008 Date expired

Sterilization — Steam sterilizers — Large sterilizers Note 2.1 (21.3.2010)

CEN EN 455-1:2000 30.9.2005 EN 455-1:1993 Date expired

Medical gloves for single use — Part 1: Requirements and Note 2.1 (30.4.2001)
testing for freedom from holes

CEN EN 455-2:2009 7.7.2010 EN 455-2:2000 Date expired

Medical gloves for single use — Part 2: Requirements and Note 2.1 (31.5.2010)
testing for physical properties

CEN EN 455-3:2006 9.8.2007 EN 455-3:1999 Date expired

Medical gloves for single use — Part 3: Requirements and Note 2.1 (30.6.2007)
testing for biological evaluation

CEN EN 455-4:2009 7.7.2010

Medical gloves for single use — Part 4: Requirements and
testing for shelf life determination

CEN EN 556-1:2001 31.7.2002 EN 556:1994 + A1:1998 Date expired

Sterilization of medical devices — Requirements for medical Note 2.1 (30.4.2002)
devices to be designated ‘Sterile’ — Part 1: Requirements for
terminally sterilized medical devices

EN 556-1:2001/AC:2006 15.11.2006

CEN EN 556-2:2003 9.8.2007

Sterilization of medical devices — Requirements for medical
devices to be designated ‘Sterile’ — Part 2: Requirements for
aseptically processed medical devices

CEN EN 794-1:1997+A2:2009 2.12.2009 EN 794-1:1997 Date expired

Lung ventilators — Part 1: Particular requirements for critical Note 2.1 (21.3.2010)
care ventilators

CEN EN 794-3:1998+A2:2009 7.7.2010 EN 794-3:1998 Date expired

Lung ventilators — Part 3: Particular requirements for Note 2.1 (21.3.2010)
emergency and transport ventilators

CEN EN 980:2008 23.7.2008 EN 980:2003 Date expired

Symbols for use in the labelling of medical devices Note 2.1 (31.5.2010)

CEN EN 1041:2008 19.2.2009 EN 1041:1998 31.8.2011

Information supplied by the manufacturer of medical devices Note 2.1

CEN EN 1060-1:1995+A2:2009 7.7.2010

Non-invasive sphygmomanometers — Part 1: General
requirements
18.1.2011 EN Official Journal of the European Union C 16/9

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 1060-2:1995+A1:2009 7.7.2010 EN 1060-2:1995 Date expired

Non-invasive sphygmomanometers — Part 2: Supplementary Note 2.1 (31.5.2010)
requirements for mechanical sphygmomanometers

CEN EN 1060-3:1997+A2:2009 7.7.2010 EN 1060-3:1997 Date expired

Non-invasive sphygmomanometers — Part 3: Supplementary Note 2.1 (31.5.2010)
requirements for electro-mechanical blood pressure measuring
systems

CEN EN 1060-4:2004 30.9.2005

Non-invasive sphygmomanometers — Part 4: Test procedures
to determine the overall system accuracy of automated non-
invasive sphygmomanometers

CEN EN 1089-3:2004 30.9.2005 EN 1089-3:1997 Date expired

Transportable gas cylinders — Gas cylinder identification Note 2.1 (31.10.2004)
(excluding LPG) — Part 3: Colour coding

CEN EN 1282-2:2005+A1:2009 7.7.2010 EN 1282-2:2005 Date expired

Tracheostomy tubes — Part 2: Paediatric tubes (ISO Note 2.1 (21.3.2010)
5366-3:2001, modified)

CEN EN 1422:1997+A1:2009 2.12.2009 EN 1422:1997 Date expired

Sterilizers for medical purposes — Ethylene oxide sterilizers — Note 2.1 (21.3.2010)
Requirements and test methods

CEN EN 1618:1997 9.5.1998

Catheters other than intravascular catheters — Test methods for
common properties

CEN EN 1639:2009 7.7.2010 EN 1639:2004 Date expired

Dentistry — Medical devices for dentistry — Instruments Note 2.1 (30.4.2010)

CEN EN 1640:2009 7.7.2010 EN 1640:2004 Date expired

Dentistry — Medical devices for dentistry — Equipment Note 2.1 (30.4.2010)

CEN EN 1641:2009 7.7.2010 EN 1641:2004 Date expired

Dentistry — Medical devices for dentistry — Materials Note 2.1 (30.4.2010)

CEN EN 1642:2009 7.7.2010 EN 1642:2004 Date expired

Dentistry — Medical devices for dentistry — Dental implants Note 2.1 (30.4.2010)

CEN EN 1707:1996 17.5.1997

Conical fittings with a 6 % (Luer) taper for syringes, needles and
certain other medical equipment — Lock fittings

CEN EN 1782:1998+A1:2009 7.7.2010 EN 1782:1998 Date expired

Tracheal tubes and connectors Note 2.1 (21.3.2010)

CEN EN 1789:2007+A1:2010 This is the first

Medical vehicles and their equipment — Road ambulances publication
C 16/10 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 1820:2005+A1:2009 7.7.2010 EN 1820:2005 Date expired

Anaesthetic reservoir bags (ISO 5362:2000, modified) Note 2.1 (21.3.2010)

CEN EN 1985:1998 10.8.1999

Walking aids — General requirements and test methods

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 3826-2:2008 19.2.2009

Plastics collapsible containers for human blood and blood
components — Part 2: Graphical symbols for use on labels
and instruction leaflets (ISO 3826-2:2008)

CEN EN ISO 3826-3:2007 27.2.2008

Plastics collapsible containers for human blood and blood
components — Part 3: Blood bag systems with integrated
features (ISO 3826-3:2006)

CEN EN ISO 4074:2002 31.7.2002 EN 600:1996 Date expired

Natural latex rubber condoms — Requirements and test Note 2.1 (31.8.2005)
methods (ISO 4074:2002)

EN ISO 4074:2002/AC:2008 2.12.2009

CEN EN ISO 4135:2001 31.7.2002 EN ISO 4135:1996 Date expired

Anaesthetic and respiratory equipment — Vocabulary (ISO Note 2.1 (28.2.2002)
4135:2001)

CEN EN ISO 5356-1:2004 30.9.2005 EN 1281-1:1997 Date expired

Anaesthetic and respiratory equipment — Conical connectors Note 2.1 (30.11.2004)
— Part 1: Cones and sockets (ISO 5356-1:2004)

CEN EN ISO 5356-2:2007 9.11.2007 EN 1281-2:1995 Date expired

Anaesthetic and respiratory equipment — Conical connectors Note 2.1 (29.2.2008)
— Part 2: Screw-threaded weight-bearing connectors (ISO
5356-2:2006)

CEN EN ISO 5359:2008 23.7.2008 EN 739:1998 Date expired

Low-pressure hose assemblies for use with medical gases (ISO Note 2.1 (30.6.2010)
5359:2008)

CEN EN ISO 5360:2009 2.12.2009 EN ISO 5360:2007 Date expired

Anaesthetic vaporizers — Agent-specific filling systems (ISO Note 2.1 (21.3.2010)
5360:2006)

CEN EN ISO 5366-1:2009 2.12.2009 EN ISO 5366-1:2004 Date expired

Anaesthetic and respiratory equipment — Tracheostomy tubes Note 2.1 (21.3.2010)
— Part 1: Tubes and connectors for use in adults (ISO
5366-1:2000)

CEN EN ISO 5840:2009 2.12.2009 EN ISO 5840:2005 Date expired

Cardiovascular implants — Cardiac valve prostheses (ISO Note 2.1 (21.3.2010)
5840:2005)
18.1.2011 EN Official Journal of the European Union C 16/11

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 7197:2009 2.12.2009 EN ISO 7197:2006 Date expired

Neurosurgical implants — Sterile, single-use hydrocephalus Note 2.1 (21.3.2010)
shunts and components (ISO 7197:2006, including Cor
1:2007)

CEN EN ISO 7376:2009 2.12.2009 EN ISO 7376:2009 Date expired

Anaesthetic and respiratory equipment — Laryngoscopes for Note 2.1 (21.3.2010)
tracheal intubation (ISO 7376:2009)

CEN EN ISO 7396-1:2007 9.8.2007 EN 737-3:1998 Date expired

Medical gas pipeline systems — Part 1: Pipeline systems for Note 2.1 (30.4.2009)
compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007/A1:2010 7.7.2010 Note 3 Date expired

(31.7.2010)

EN ISO 7396-1:2007/A2:2010 7.7.2010 Note 3 Date expired

(31.8.2010)

CEN EN ISO 7396-2:2007 9.8.2007 EN 737-2:1998 Date expired

Medical gas pipeline systems — Part 2: Anaesthetic gas Note 2.1 (30.4.2009)
scavenging disposal systems (ISO 7396-2:2007)

CEN EN ISO 7439:2009 2.12.2009 EN ISO 7439:2002 Date expired

Copper-bearing intra-uterine contraceptive devices — Note 2.1 (21.3.2010)
Requirements, tests (ISO 7439:2002)

CEN EN ISO 7886-3:2009 7.7.2010 EN ISO 7886-3:2005 Date expired

Sterile hypodermic syringes for single use — Part 3: Auto- Note 2.1 (21.3.2010)
disable syringes for fixed-dose immunization (ISO
7886-3:2005)

CEN EN ISO 7886-4:2009 7.7.2010 EN ISO 7886-4:2006 Date expired

Sterile hypodermic syringes for single use — Part 4: Syringes Note 2.1 (21.3.2010)
with re-use prevention feature (ISO 7886-4:2006)

CEN EN ISO 8185:2009 2.12.2009 EN ISO 8185:2007 Date expired

Respiratory tract humidifiers for medical use — Particular Note 2.1 (21.3.2010)
requirements for respiratory humidification systems (ISO
8185:2007)

CEN EN ISO 8359:2009 2.12.2009 EN ISO 8359:1996 Date expired

Oxygen concentrators for medical use — Safety requirements Note 2.1 (21.3.2010)
(ISO 8359:1996)

CEN EN ISO 8536-4:2007 9.8.2007

Infusion equipment for medical use — Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2007)

CEN EN ISO 8835-2:2009 2.12.2009 EN ISO 8835-2:2007 Date expired

Inhalational anaesthesia systems — Part 2: Anaesthetic Note 2.1 (21.3.2010)
breathing systems (ISO 8835-2:2007)

CEN EN ISO 8835-3:2009 2.12.2009 EN ISO 8835-3:2007 Date expired

Inhalational anaesthesia systems — Part 3: Transfer and Note 2.1 (21.3.2010)
receiving systems of active anaesthetic gas scavenging systems
(ISO 8835-3:2007)
C 16/12 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 8835-4:2009 2.12.2009 EN ISO 8835-4:2004 Date expired

Inhalational anaesthesia systems — Part 4: Anaesthetic vapour Note 2.1 (21.3.2010)
delivery devices (ISO 8835-4:2004)

CEN EN ISO 8835-5:2009 2.12.2009 EN ISO 8835-5:2004 Date expired

Inhalational anaesthesia systems — Part 5: Anaesthetic Note 2.1 (21.3.2010)
ventilators (ISO 8835-5:2004)

CEN EN ISO 9170-1:2008 19.2.2009 EN 737-1:1998 Date expired

Terminal units for medical gas pipeline systems — Part 1: Note 2.1 (31.7.2010)
Terminal units for use with compressed medical gases and
vacuum (ISO 9170-1:2008)

CEN EN ISO 9170-2:2008 19.2.2009 EN 737-4:1998 Date expired

Terminal units for medical gas pipeline systems — Part 2: Note 2.1 (31.7.2010)
Terminal units for anaesthetic gas scavenging systems (ISO
9170-2:2008)

CEN EN ISO 9360-1:2009 2.12.2009 EN ISO 9360-1:2000 Date expired

Anaesthetic and respiratory equipment — Heat and moisture Note 2.1 (21.3.2010)
exchangers (HMEs) for humidifying respired gases in humans —
Part 1: HMEs for use with minimum tidal volumes of 250 ml
(ISO 9360-1:2000)

CEN EN ISO 9360-2:2009 2.12.2009 EN ISO 9360-2:2002 Date expired

Anaesthetic and respiratory equipment — Heat and moisture Note 2.1 (21.3.2010)
exchangers (HMEs) for humidifying respired gases in humans —
Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml (ISO 9360-2:2001)

CEN EN ISO 9713:2009 2.12.2009 EN ISO 9713:2004 Date expired

Neurosurgical implants — Self-closing intracranial aneurysm Note 2.1 (21.3.2010)
clips (ISO 9713:2002)

CEN EN ISO 9919:2009 2.12.2009 EN ISO 9919:2005 Date expired

Medical electrical equipment — Particular requirements for the Note 2.1 (21.3.2010)
basic safety and essential performance of pulse oximeter
equipment for medical use (ISO 9919:2005)

CEN EN ISO 10079-1:2009 2.12.2009 EN ISO 10079-1:1999 Date expired

Medical suction equipment — Part 1: Electrically powered Note 2.1 (21.3.2010)
suction equipment — Safety requirements (ISO 10079-1:1999)

CEN EN ISO 10079-2:2009 2.12.2009 EN ISO 10079-2:1999 Date expired

Medical suction equipment — Part 2: Manually powered Note 2.1 (21.3.2010)
suction equipment (ISO 10079-2:1999)

CEN EN ISO 10079-3:2009 2.12.2009 EN ISO 10079-3:1999 Date expired

Medical suction equipment — Part 3: Suction equipment Note 2.1 (21.3.2010)
powered from a vacuum or pressure source (ISO
10079-3:1999)

CEN EN ISO 10328:2006 9.8.2007

Prosthetics — Structural testing of lower-limb prostheses —
Requirements and test methods (ISO 10328:2006)
18.1.2011 EN Official Journal of the European Union C 16/13

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 10524-1:2006 2.6.2006 EN 738-1:1997 Date expired

Pressure regulators for use with medical gases — Part 1: Note 2.1 (31.10.2008)
Pressure regulators and pressure regulators with flow-metering
devices (ISO 10524-1:2006)

CEN EN ISO 10524-2:2006 7.6.2009 EN 738-2:1998 Date expired

Pressure regulators for use with medical gases — Part 2: Note 2.1 (31.10.2008)
Manifold and line pressure regulators (ISO 10524-2:2005)

CEN EN ISO 10524-3:2006 7.9.2006 EN 738-3:1998 Date expired

Pressure regulators for use with medical gases — Part 3: Note 2.1 (31.10.2008)
Pressure regulators integrated with cylinder valves (ISO
10524-3:2005)

CEN EN ISO 10524-4:2008 23.7.2008 EN 738-4:1998 Date expired

Pressure regulators for use with medical gases — Part 4: Low- Note 2.1 (30.6.2010)
pressure regulators (ISO 10524-4:2008)

CEN EN ISO 10535:2006 9.8.2007 EN ISO 10535:1998 Date expired

Hoists for the transfer of disabled persons — Requirements and Note 2.1 (30.6.2007)
test methods (ISO 10535:2006)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 10555-1:2009 2.12.2009 EN ISO 10555-1:1996 Date expired

Sterile, single-use intravascular catheters — Part 1: General Note 2.1 (21.3.2010)
requirements (ISO 10555-1:1995, including Amd 1:1999 and
Amd 2:2004)

CEN EN ISO 10651-2:2009 2.12.2009 EN ISO 10651-2:2004 Date expired

Lung ventilators for medical use — Particular requirements for Note 2.1 (21.3.2010)
basic safety and essential performance — Part 2: Home care
ventilators for ventilator-dependent patients (ISO
10651-2:2004)

CEN EN ISO 10651-4:2009 2.12.2009 EN ISO 10651-4:2002 Date expired

Lung ventilators — Part 4: Particular requirements for operator- Note 2.1 (21.3.2010)
powered resuscitators (ISO 10651-4:2002)

CEN EN ISO 10651-6:2009 2.12.2009 EN ISO 10651-6:2004 Date expired

Lung ventilators for medical use — Particular requirements for Note 2.1 (21.3.2010)
basic safety and essential performance — Part 6: Home-care
ventilatory support devices (ISO 10651-6:2004)

CEN EN ISO 10993-1:2009 2.12.2009 EN ISO 10993-1:2009 Date expired

Biological evaluation of medical devices — Part 1: Evaluation Note 2.1 (21.3.2010)
and testing within a risk management process (ISO
10993-1:2009)

EN ISO 10993-1:2009/AC:2010 This is the first

publication
C 16/14 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 10993-3:2009 2.12.2009 EN ISO 10993-3:2003 Date expired

Biological evaluation of medical devices — Part 3: Tests for Note 2.1 (21.3.2010)
genotoxicity, carcinogenicity and reproductive toxicity (ISO
10993-3:2003)

CEN EN ISO 10993-4:2009 2.12.2009 EN ISO 10993-4:2002 Date expired

Biological evaluation of medical devices — Part 4: Selection of Note 2.1 (21.3.2010)
tests for interactions with blood (ISO 10993-4:2002, including
Amd 1:2006)

CEN EN ISO 10993-5:2009 2.12.2009 EN ISO 10993-5:1999 Date expired

Biological evaluation of medical devices — Part 5: Tests for in Note 2.1 (31.12.2009)
vitro cytotoxicity (ISO 10993-5:2009)

CEN EN ISO 10993-6:2009 2.12.2009 EN ISO 10993-6:2007 Date expired

Biological evaluation of medical devices — Part 6: Tests for Note 2.1 (21.3.2010)
local effects after implantation (ISO 10993-6:2007)

CEN EN ISO 10993-7:2008 19.2.2009

Biological evaluation of medical devices — Part 7: Ethylene
oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008/AC:2009 7.7.2010

CEN EN ISO 10993-9:2009 2.12.2009 EN ISO 10993-9:2009 Date expired

Biological evaluation of medical devices — Part 9: Framework Note 2.1 (21.3.2010)
for identification and quantification of potential degradation
products (ISO 10993-9:2009)

CEN EN ISO 10993-11:2009 2.12.2009 EN ISO 10993-11:2006 Date expired

Biological evaluation of medical devices — Part 11: Tests for Note 2.1 (21.3.2010)
systemic toxicity (ISO 10993-11:2006)

CEN EN ISO 10993-12:2009 2.12.2009 EN ISO 10993-12:2007 Date expired

Biological evaluation of medical devices — Part 12: Sample Note 2.1 (21.3.2010)
preparation and reference materials (ISO 10993-12:2007)

CEN EN ISO 10993-13:2010 This is the first EN ISO 10993-13:2009 31.12.2010

Biological evaluation of medical devices — Part 13: Identifi­ publication Note 2.1
cation and quantification of degradation products from
polymeric medical devices (ISO 10993-13:2010)

CEN EN ISO 10993-14:2009 2.12.2009 EN ISO 10993-14:2001 Date expired

Biological evaluation of medical devices — Part 14: Identifi­ Note 2.1 (21.3.2010)
cation and quantification of degradation products from
ceramics (ISO 10993-14:2001)

CEN EN ISO 10993-15:2009 2.12.2009 EN ISO 10993-15:2000 Date expired

Biological evaluation of medical devices — Part 15: Identifi­ Note 2.1 (21.3.2010)
cation and quantification of degradation products from metals
and alloys (ISO 10993-15:2000)

CEN EN ISO 10993-16:2010 7.7.2010 EN ISO 10993-16:2009 Date expired

Biological evaluation of medical devices — Part 16: Toxi­ Note 2.1 (31.8.2010)
cokinetic study design for degradation products and leachables
(ISO 10993-16:2010)
18.1.2011 EN Official Journal of the European Union C 16/15

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 10993-17:2009 2.12.2009 EN ISO 10993-17:2002 Date expired

Biological evaluation of medical devices — Part 17: Estab­ Note 2.1 (21.3.2010)
lishment of allowable limits for leachable substances (ISO
10993-17:2002)

CEN EN ISO 10993-18:2009 2.12.2009 EN ISO 10993-18:2005 Date expired

Biological evaluation of medical devices — Part 18: Chemical Note 2.1 (21.3.2010)
characterization of materials (ISO 10993-18:2005)

CEN EN ISO 11135-1:2007 9.8.2007 EN 550:1994 Date expired

Sterilization of health care products — Ethylene oxide — Part Note 2.1 (31.5.2010)
1: Requirements for development, validation and routine
control of a sterilization process for medical devices (ISO
11135-1:2007)

CEN EN ISO 11137-1:2006 7.9.2006 EN 552:1994 Date expired

Sterilization of health care products — Radiation — Part 1: Note 2.1 (30.4.2009)
Requirements for development, validation and routine control
of a sterilization process for medical devices (ISO
11137-1:2006)

CEN EN ISO 11137-2:2007 9.8.2007

Sterilization of health care products — Radiation — Part 2:
Establishing the sterilization dose (ISO 11137-2:2006,
corrected version 2006-08-01)

EN ISO 11137-2:2007/AC:2009 2.12.2009

CEN EN ISO 11138-2:2009 2.12.2009 EN ISO 11138-2:2006 Date expired

Sterilization of health care products — Biological indicators — Note 2.1 (21.3.2010)
Part 2: Biological indicators for ethylene oxide sterilization
processes (ISO 11138-2:2006)

CEN EN ISO 11138-3:2009 2.12.2009 EN ISO 11138-3:2006 Date expired

Sterilization of health care products — Biological indicators — Note 2.1 (21.3.2010)
Part 3: Biological indicators for moist heat sterilization
processes (ISO 11138-3:2006)

CEN EN ISO 11140-1:2009 2.12.2009 EN ISO 11140-1:2005 Date expired

Sterilization of health care products — Chemical indicators — Note 2.1 (21.3.2010)
Part 1: General requirements (ISO 11140-1:2005)

CEN EN ISO 11140-3:2009 2.12.2009 EN ISO 11140-3:2007 Date expired

Sterilization of health care products — Chemical indicators — Note 2.1 (21.3.2010)
Part 3: Class 2 indicator systems for use in the Bowie and Dick-
type steam penetration test (ISO 11140-3:2007, including Cor
1:2007)

CEN EN ISO 11197:2009 2.12.2009 EN ISO 11197:2004 Date expired

Medical supply units (ISO 11197:2004) Note 2.1 (21.3.2010)

CEN EN ISO 11607-1:2009 2.12.2009 EN ISO 11607-1:2006 Date expired

Packaging for terminally sterilized medical devices — Part 1: Note 2.1 (21.3.2010)
Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2006)

CEN EN ISO 11607-2:2006 7.9.2006

Packaging for terminally sterilized medical devices — Part 2:
Validation requirements for forming, sealing and assembly
processes (ISO 11607-2:2006)
C 16/16 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 11737-1:2006 7.9.2006 EN 1174-2:1996 Date expired

Sterilization of medical devices — Microbiological methods — EN 1174-1:1996 (31.10.2006)
Part 1: Determination of a population of microorganisms on EN 1174-3:1996
products (ISO 11737-1:2006)
Note 2.1

EN ISO 11737-1:2006/AC:2009 2.12.2009

CEN EN ISO 11737-2:2009 7.7.2010

Sterilization of medical devices — Microbiological methods —
Part 2: Tests of sterility performed in the definition, validation
and maintenance of a sterilization process (ISO 11737-2:2009)

CEN EN ISO 11810-1:2009 2.12.2009

Lasers and laser-related equipment — Test method and classifi­
cation for the laser resistance of surgical drapes and/or patient
protective covers — Part 1: Primary ignition and penetration
(ISO 11810-1:2005)

CEN EN ISO 11810-2:2009 2.12.2009 EN ISO 11810-2:2007 Date expired

Lasers and laser-related equipment — Test method and classifi­ Note 2.1 (21.3.2010)
cation for the laser-resistance of surgical drapes and/or patient-
protective covers — Part 2: Secondary ignition (ISO
11810-2:2007)

CEN EN ISO 11979-8:2009 2.12.2009 EN ISO 11979-8:2006 Date expired

Ophthalmic implants — Intraocular lenses — Part 8: Funda­ Note 2.1 (21.3.2010)
mental requirements (ISO 11979-8:2006)

CEN EN ISO 11990:2003 7.11.2003 EN ISO 11990:1999 Date expired

Optics and optical instruments — Lasers and laser-related Note 2.1 (31.10.2003)
equipment — Determination of laser resistance of tracheal
tube shafts (ISO 11990:2003)

CEN EN 12006-2:1998+A1:2009 2.12.2009 EN 12006-2:1998 Date expired

Non active surgical implants — Particular requirements for Note 2.1 (21.3.2010)
cardiac and vascular implants — Part 2: Vascular prostheses
including cardiac valve conduits

CEN EN 12006-3:1998+A1:2009 2.12.2009 EN 12006-3:1998 Date expired

Non active surgical implants — Particular requirements for Note 2.1 (21.3.2010)
cardiac and vascular implants — Part 3: Endovascular devices

CEN EN 12182:1999 14.10.2000

Technical aids for disabled persons — General requirements
and test methods

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN 12183:2009 7.7.2010

Manual wheelchairs — Requirements and test methods

CEN EN 12184:2009 7.7.2010

Electrically powered wheelchairs, scooters and their chargers —
Requirements and test methods
18.1.2011 EN Official Journal of the European Union C 16/17

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 12342:1998+A1:2009 7.7.2010 EN 12342:1998 Date expired

Breathing tubes intended for use with anaesthetic apparatus and Note 2.1 (21.3.2010)
ventilators

CEN EN 12470-1:2000+A1:2009 2.12.2009 EN 12470-1:2000 Date expired

Clinical thermometers — Part 1: Metallic liquid-in-glass ther­ Note 2.1 (21.3.2010)
mometers with maximum device

CEN EN 12470-2:2000+A1:2009 2.12.2009 EN 12470-2:2000 Date expired

Clinical thermometers — Part 2: Phase change type (dot matrix) Note 2.1 (21.3.2010)
thermometers

CEN EN 12470-3:2000+A1:2009 2.12.2009 EN 12470-3:2000 Date expired

Clinical thermometers — Part 3: Performance of compact elec­ Note 2.1 (21.3.2010)
trical thermometers (non-predictive and predictive) with
maximum device

CEN EN 12470-4:2000+A1:2009 2.12.2009 EN 12470-4:2000 Date expired

Clinical thermometers — Part 4: Performance of electrical ther­ Note 2.1 (21.3.2010)
mometers for continuous measurement

CEN EN 12470-5:2003 7.11.2003

Clinical thermometers — Part 5: Performance of infra-red ear
thermometers (with maximum device)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 12870:2009 2.12.2009 EN ISO 12870:2004 Date expired

Ophthalmic optics — Spectacle frames — Requirements and Note 2.1 (21.3.2010)
test methods (ISO 12870:2004)

CEN EN 13060:2004+A2:2010 7.7.2010 EN Date expired

Small steam sterilizers 13060:2004+A1:2009 (30.9.2010)
Note 2.1

CEN EN ISO 13485:2003 2.4.2004 EN ISO 13488:2000 Date expired

Medical devices — Quality management systems — EN ISO 13485:2000 (31.7.2009)
Requirements for regulatory purposes (ISO 13485:2003) EN 46003:1999
Note 2.1

EN ISO 13485:2003/AC:2009 7.7.2010

CEN EN 13544-1:2007+A1:2009 7.7.2010 EN 13544-1:2007 Date expired

Respiratory therapy equipment — Part 1: Nebulizing systems Note 2.1 (21.3.2010)
and their components

CEN EN 13544-2:2002+A1:2009 7.7.2010 EN 13544-2:2002 Date expired

Respiratory therapy equipment — Part 2: Tubing and Note 2.1 (21.3.2010)
connectors

CEN EN 13544-3:2001+A1:2009 7.7.2010 EN 13544-3:2001 Date expired

Respiratory therapy equipment — Part 3: Air entrainment Note 2.1 (21.3.2010)
devices
C 16/18 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 13624:2003 30.9.2005

Chemical disinfectants and antiseptics — Quantitative
suspension test for the evaluation of fungicidal activity of
chemical disinfectants for instruments used in the medical
area — Test method and requirements (phase 2, step 1)

CEN EN 13718-1:2008 19.2.2009 EN 13718-1:2002 Date expired

Medical vehicles and their equipment — Air ambulances — Note 2.1 (28.2.2009)
Part 1: Requirements for medical devices used in air ambulances

CEN EN 13726-1:2002 27.3.2003

Test methods for primary wound dressings — Part 1: Aspects
of absorbency

EN 13726-1:2002/AC:2003 2.12.2009

CEN EN 13726-2:2002 27.3.2003

Test methods for primary wound dressings — Part 2: Moisture
vapour transmission rate of permeable film dressings

CEN EN 13727:2003 30.9.2005

Chemical disinfectants and antiseptics — Quantitative
suspension test for the evaluation of bactericidal activity of
chemical disinfectants for instruments used in the medical
area — Test method and requirements (phase 2, step 1)

CEN EN 13795-1:2002+A1:2009 7.7.2010 EN 13795-1:2002 Date expired

Surgical drapes, gowns and clean air suits, used as medical Note 2.1 (21.3.2010)
devices, for patients, clinical staff and equipment — Part 1:
General requirements for manufacturers, processors and
products

CEN EN 13795-2:2004+A1:2009 7.7.2010 EN 13795-2:2004 Date expired

Surgical drapes, gowns and clean air suits, used as medical Note 2.1 (21.3.2010)
devices for patients, clinical staff and equipment — Part 2:
Test methods

CEN EN 13795-3:2006+A1:2009 7.7.2010 EN 13795-3:2006 Date expired

Surgical drapes, gowns and clean air suits, used as medical Note 2.1 (21.3.2010)
devices for patients, clinical staff and equipment — Part 3:
Performance requirements and performance levels

CEN EN 13824:2004 30.9.2005

Sterilization of medical devices — Aseptic processing of liquid
medical devices — Requirements

CEN EN 13867:2002+A1:2009 2.12.2009 EN 13867:2002 Date expired

Concentrates for haemodialysis and related therapies Note 2.1 (21.3.2010)

CEN EN 13976-1:2003 30.9.2005

Rescue systems — Transportation of incubators — Part 1:
Interface conditions

CEN EN 13976-2:2003 30.9.2005

Rescue systems — Transportation of incubators — Part 2:
System requirements
18.1.2011 EN Official Journal of the European Union C 16/19

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

EN 13976-2:2003/AC:2004 2.12.2009

CEN EN 14079:2003 30.9.2005

Non-active medical devices — Performance requirements and
test methods for absorbent cotton gauze and absorbent cotton
and viscose gauze

CEN EN 14139:2010 This is the first

Ophthalmic optics — Specifications for ready-to-wear spec­ publication
tacles

CEN EN ISO 14155-1:2009 7.7.2010 EN ISO 14155-1:2003 Date expired

Clinical investigation of medical devices for human subjects — Note 2.1 (21.3.2010)
Part 1: General requirements (ISO 14155-1:2003)

CEN EN ISO 14155-2:2009 7.7.2010 EN ISO 14155-2:2003 Date expired

Clinical investigation of medical devices for human subjects — Note 2.1 (21.3.2010)
Part 2: Clinical investigation plans (ISO 14155-2:2003)

CEN EN ISO 14160:1998 27.8.1998

Sterilization of single-use medical devices incorporating
materials of animal origin — Validation and routine control
of sterilization by liquid chemical sterilants (ISO 14160:1998)

CEN EN 14180:2003+A2:2009 7.7.2010 EN Date expired

Sterilizers for medical purposes — Low temperature steam and 14180:2003+A1:2009 (21.3.2010)
formaldehyde sterilizers — Requirements and testing Note 2.1

CEN EN 14348:2005 30.9.2005

Chemical disinfectants and antiseptics — Quantitative
suspension test for the evaluation of mycobactericidal activity
of chemical disinfectants in the medical area including
instrument disinfectants — Test methods and requirements
(phase 2, step 1)

CEN EN ISO 14408:2009 2.12.2009 EN ISO 14408:2005 Date expired

Tracheal tubes designed for laser surgery — Requirements for Note 2.1 (21.3.2010)
marking and accompanying information (ISO 14408:2005)

CEN EN ISO 14534:2009 2.12.2009 EN ISO 14534:2002 Date expired

Ophthalmic optics — Contact lenses and contact lens care Note 2.1 (21.3.2010)
products — Fundamental requirements (ISO 14534:2002)

CEN EN 14561:2006 15.11.2006

Chemical disinfectants and antiseptics — Quantitative carrier
test for the evaluation of bactericidal activity for instruments
used in the medical area — Test method and requirements
(phase 2, step 2)

CEN EN 14562:2006 15.11.2006

Chemical disinfectants and antiseptics — Quantitative carrier
test for the evaluation of fungicidal or yeasticidal activity for
instruments used in the medical area — Test method and
requirements (phase 2, step 2)
C 16/20 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN 14563:2008 19.2.2009

Chemical disinfectants and antiseptics — Quantitative carrier
test for the evaluation of mycobactericidal or tuberculocidal
activity of chemical disinfectants used for instruments in the
medical area — Test method and requirements (phase 2, step 2)

CEN EN ISO 14607:2009 2.12.2009 EN ISO 14607:2007 Date expired

Non-active surgical implants — Mammary implants — Note 2.1 (21.3.2010)
Particular requirements (ISO 14607:2007)

CEN EN ISO 14630:2009 2.12.2009 EN ISO 14630:2008 Date expired

Non-active surgical implants — General requirements (ISO Note 2.1 (21.3.2010)
14630:2008)

CEN EN 14683:2005 2.6.2006

Surgical masks — Requirements and test methods

CEN EN ISO 14889:2009 2.12.2009 EN ISO 14889:2003 Date expired

Ophthalmic optics — Spectacle lenses — Fundamental Note 2.1 (21.3.2010)
requirements for uncut finished lenses (ISO 14889:2003)

CEN EN 14931:2006 15.11.2006

Pressure vessels for human occupancy (PVHO) — Multi-place
pressure chamber systems for hyperbaric therapy —
Performance, safety requirements and testing

CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 Date expired

Sterilization of health care products — General requirements Note 2.1 (30.4.2010)
for characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for
medical devices (ISO 14937:2009)

CEN EN ISO 14971:2009 7.7.2010 EN ISO 14971:2007 Date expired

Medical devices — Application of risk management to medical Note 2.1 (21.3.2010)
devices (ISO 14971:2007, Corrected version 2007-10-01)

CEN EN ISO 15002:2008 19.2.2009 EN 13220:1998 Date expired

Flow-metering devices for connection to terminal units of Note 2.1 (31.7.2010)
medical gas pipeline systems (ISO 15002:2008)

CEN EN ISO 15004-1:2009 2.12.2009 EN ISO 15004-1:2006 Date expired

Ophthalmic instruments — Fundamental requirements and test Note 2.1 (21.3.2010)
methods — Part 1: General requirements applicable to all
ophthalmic instruments (ISO 15004-1:2006)

CEN EN 15424:2007 9.8.2007

Sterilization of medical devices — Low temperature steam and
formaldehyde — Requirements for development, validation and
routine control of a sterilization process for medical devices

CEN EN 15546-1:2008 23.7.2008

Small bore connectors for liquids and gases in healthcare appli­
cations — Part 1 — General Requirements

CEN EN ISO 15798:2010 7.7.2010

Ophthalmic implants — Ophthalmic viscosurgical devices (ISO
15798:2010)
18.1.2011 EN Official Journal of the European Union C 16/21

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 15883-1:2009 2.12.2009 EN ISO 15883-1:2006 Date expired

Washer-disinfectors — Part 1: General requirements, terms and Note 2.1 (21.3.2010)
definitions and tests (ISO 15883-1:2006)

CEN EN ISO 15883-2:2009 2.12.2009 EN ISO 15883-2:2006 Date expired

Washer-disinfectors — Part 2: Requirements and tests for Note 2.1 (21.3.2010)
washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers,
utensils, glassware, etc. (ISO 15883-2:2006)

CEN EN ISO 15883-3:2009 2.12.2009 EN ISO 15883-3:2006 Date expired

Washer-disinfectors — Part 3: Requirements and tests for Note 2.1 (21.3.2010)
washer-disinfectors employing thermal disinfection for human
waste containers (ISO 15883-3:2006)

CEN EN ISO 15883-4:2009 2.12.2009 EN ISO 15883-4:2008 Date expired

Washer-disinfectors — Part 4: Requirements and tests for Note 2.1 (21.3.2010)
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2008)

CEN EN ISO 16061:2009 7.7.2010 EN ISO 16061:2008 Date expired

Instrumentation for use in association with non-active surgical Note 2.1 (28.2.2010)
implants — General requirements (ISO 16061:2008, Corrected
version 2009-03-15)

CEN EN ISO 16201:2006 19.2.2009

Technical aids for disabled persons — Environmental control
systems for daily living (ISO 16201:2006)

CEN EN ISO 17510-1:2009 2.12.2009 EN ISO 17510-1:2007 Date expired

Sleep apnoea breathing therapy — Part 1: Sleep apnoea Note 2.1 (21.3.2010)
breathing therapy equipment (ISO 17510-1:2007)

CEN EN ISO 17510-2:2009 2.12.2009 EN ISO 17510-2:2007 Date expired

Sleep apnoea breathing therapy — Part 2: Masks and appli­ Note 2.1 (21.3.2010)
cation accessories (ISO 17510-2:2007)

CEN EN ISO 17664:2004 30.9.2005

Sterilization of medical devices — Information to be provided
by the manufacturer for the processing of resterilizable medical
devices (ISO 17664:2004)

CEN EN ISO 17665-1:2006 15.11.2006 EN 554:1994 Date expired

Sterilization of health care products — Moist heat — Part 1: Note 2.1 (31.8.2009)
Requirements for the development, validation and routine
control of a sterilization process for medical devices (ISO
17665-1:2006)

CEN EN ISO 18777:2009 2.12.2009 EN ISO 18777:2005 Date expired

Transportable liquid oxygen systems for medical use — Note 2.1 (21.3.2010)
Particular requirements (ISO 18777:2005)

CEN EN ISO 18778:2009 2.12.2009 EN ISO 18778:2005 Date expired

Respiratory equipment — Infant monitors — Particular Note 2.1 (21.3.2010)
requirements (ISO 18778:2005)
C 16/22 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 18779:2005 30.9.2005

Medical devices for conserving oxygen and oxygen mixtures —
Particular requirements (ISO 18779:2005)

CEN EN ISO 19054:2006 7.9.2006 EN 12218:1998 Date expired

Rail systems for supporting medical equipment (ISO Note 2.1 (30.6.2008)
19054:2005)

CEN EN 20594-1:1993 18.11.1995

Conical fittings with a 6 % (Luer) taper for syringes, needles and
certain other medical equipment — Part 1: General
requirements (ISO 594-1:1986)

EN 20594-1:1993/A1:1997 10.8.1999 Note 3 Date expired

(31.5.1998)

EN 20594-1:1993/AC:1996 2.12.2009

CEN EN ISO 21171:2006 7.9.2006

Medical gloves — Determination of removable surface powder
(ISO 21171:2006)

CEN EN ISO 21534:2009 2.12.2009 EN ISO 21534:2007 Date expired

Non-active surgical implants — Joint replacement implants — Note 2.1 (21.3.2010)
Particular requirements (ISO 21534:2007)

CEN EN ISO 21535:2009 2.12.2009 EN ISO 21535:2007 Date expired

Non-active surgical implants — Joint replacement implants — Note 2.1 (21.3.2010)
Specific requirements for hip-joint replacement implants (ISO
21535:2007)

CEN EN ISO 21536:2009 2.12.2009 EN ISO 21536:2007 Date expired

Non-active surgical implants — Joint replacement implants — Note 2.1 (21.3.2010)
Specific requirements for knee-joint replacement implants (ISO
21536:2007)

CEN EN ISO 21647:2009 2.12.2009 EN ISO 21647:2004 Date expired

Medical electrical equipment — Particular requirements for the Note 2.1 (21.3.2010)
basic safety and essential performance of respiratory gas
monitors (ISO 21647:2004, including Cor 1:2005)

CEN EN ISO 21649:2009 7.7.2010 EN ISO 21649:2006 Date expired

Needle-free injectors for medical use — Requirements and test Note 2.1 (21.3.2010)
methods (ISO 21649:2006)

CEN EN ISO 21969:2009 7.7.2010 EN ISO 21969:2006 Date expired

High-pressure flexible connections for use with medical gas Note 2.1 (31.5.2010)
systems (ISO 21969:2009)

CEN EN ISO 21987:2009 7.7.2010

Ophthalmic optics — Mounted spectacle lenses (ISO
21987:2009)

CEN EN ISO 22442-1:2007 27.2.2008 EN 12442-1:2000 Date expired

Medical devices utilizing animal tissues and their derivatives — Note 2.1 (30.6.2008)
Part 1: Application of risk management (ISO 22442-1:2007)
18.1.2011 EN Official Journal of the European Union C 16/23

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 22442-2:2007 27.2.2008 EN 12442-2:2000 Date expired

Medical devices utilizing animal tissues and their derivatives — Note 2.1 (30.6.2008)
Part 2: Controls on sourcing, collection and handling (ISO
22442-2:2007)

CEN EN ISO 22442-3:2007 27.2.2008 EN 12442-3:2000 Date expired

Medical devices utilizing animal tissues and their derivatives — Note 2.1 (30.6.2008)
Part 3: Validation of the elimination and/or inactivation of
viruses and transmissible spongiform encephalopathy (TSE)
agents (ISO 22442-3:2007)

CEN EN ISO 22523:2006 9.8.2007 EN 12523:1999 Date expired

External limb prostheses and external orthoses — Requirements Note 2.1 (30.4.2007)
and test methods (ISO 22523:2006)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 22610:2006 15.11.2006

Surgical drapes, gowns and clean air suits, used as medical
devices, for patients, clinical staff and equipment — Test
method to determine the resistance to wet bacterial penetration
(ISO 22610:2006)

CEN EN ISO 22612:2005 30.9.2005

Clothing for protection against infectious agents — Test
method for resistance to dry microbial penetration (ISO
22612:2005)

CEN EN ISO 22675:2006 9.8.2007

Prosthetics — Testing of ankle-foot devices and foot units —
Requirements and test methods (ISO 22675:2006)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be
published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are
appropriately covered.

CEN EN ISO 23328-1:2008 19.2.2009 EN 13328-1:2001 Date expired

Breathing system filters for anaesthetic and respiratory use — Note 2.1 (30.9.2008)
Part 1: Salt test method to assess filtration performance (ISO
23328-1:2003)

CEN EN ISO 23328-2:2009 2.12.2009 EN ISO 23328-2:2008 Date expired

Breathing system filters for anaesthetic and respiratory use — Note 2.1 (21.3.2010)
Part 2: Non-filtration aspects (ISO 23328-2:2002)

CEN EN ISO 23747:2009 2.12.2009 EN ISO 23747:2007 Date expired

Anaesthetic and respiratory equipment — Peak expiratory flow Note 2.1 (21.3.2010)
meters for the assessment of pulmonary function in spon­
taneously breathing humans (ISO 23747:2007)

CEN EN ISO 25539-1:2009 2.12.2009 EN ISO 25539-1:2008 Date expired

Cardiovascular implants — Endovascular devices — Part 1: Note 2.1 (21.3.2010)
Endovascular prostheses (ISO 25539-1:2003 including Amd
1:2005)

CEN EN ISO 25539-2:2009 2.12.2009 EN ISO 25539-2:2008 Date expired

Cardiovascular implants — Endovascular devices — Part 2: Note 2.1 (21.3.2010)
Vascular stents (ISO 25539-2:2008)
C 16/24 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

CEN EN ISO 26782:2009 7.7.2010

Anaesthetic and respiratory equipment — Spirometers intended
for the measurement of time forced expired volumes in humans
(ISO 26782:2009)

EN ISO 26782:2009/AC:2009 7.7.2010

CEN EN 27740:1992 18.11.1995

Instruments for surgery, scalpels with detachable blades, fitting
dimensions (ISO 7740:1985)

EN 27740:1992/A1:1997 10.8.1999 Note 3 Date expired

(31.5.1998)

EN 27740:1992/AC:1996 2.12.2009

Cenelec EN 60118-13:2005 19.1.2006 EN 60118-13:1997 Date expired

Electroacoustics — Hearing aids — Part 13: Electromagnetic Note 2.1 (1.2.2008)
compatibility (EMC)
IEC 60118-13:2004 (*)

Cenelec EN 60522:1999 14.11.2001

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

Cenelec EN 60580:2000 13.12.2002

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

Cenelec EN 60601-1:1990 18.11.1995

Medical electrical equipment — Part 1: General requirements
for safety
IEC 60601-1:1988

EN 60601-1:1990/A1:1993 18.11.1995 Note 3 The date of this

IEC 60601-1:1988/A1:1991 publication

EN 60601-1:1990/A2:1995 18.11.1995 Note 3 The date of this

IEC 60601-1:1988/A2:1995 (*) publication

EN 60601-1:1990/AC:1994 This is the first

publication

Cenelec EN 60601-1:2006 27.11.2008 EN 60601-1:1990 1.6.2012

Medical electrical equipment — Part 1: General requirements and its amendments
for basic safety and essential performance + EN 60601-1-1:2001
IEC 60601-1:2005 (*) + EN 60601-1-4:1996
and its amendment
Note 2.1
18.1.2011 EN Official Journal of the European Union C 16/25

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

EN 60601-1:2006/AC:2010 This is the first

publication

Cenelec EN 60601-1-1:2001 14.11.2001 EN 60601-1-1:1993 Date expired

Medical electrical equipment — Part 1-1: General requirements + A1:1996 (1.11.2003)
for safety — Collateral standard: Safety requirements for Note 2.1
medical electrical systems
IEC 60601-1-1:2000 (*)

Cenelec EN 60601-1-2:2001 13.12.2002 EN 60601-1-2:1993 Date expired

Medical electrical equipment — Part 1-2: General requirements Note 2.1 (1.11.2004)
for safety — Collateral standard: Electromagnetic compatibility
— Requirements and tests
IEC 60601-1-2:2001

EN 60601-1-2:2001/A1:2006 22.12.2007 Note 3 Date expired

IEC 60601-1-2:2001/A1:2004 (*) (1.3.2009)

Cenelec EN 60601-1-2:2007 27.11.2008 EN 60601-1-2:2001 1.6.2012

Medical electrical equipment — Part 1-2: General requirements and its amendment
for basic safety and essential performance — Collateral Note 2.1
standard: Electromagnetic compatibility — Requirements and
tests
IEC 60601-1-2:2007 (Modified) (*)

EN 60601-1-2:2007/AC:2010 This is the first

publication

Cenelec EN 60601-1-3:1994 18.11.1995

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 60601-1-3:2008 27.11.2008 EN 60601-1-3:1994 1.6.2012

Medical electrical equipment — Part 1-3: General requirements Note 2.1
for basic safety and essential performance — Collateral
Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:2008 (*)

EN 60601-1-3:2008/AC:2010 This is the first

publication

Cenelec EN 60601-1-4:1996 8.11.1997

Medical electrical equipment — Part 1-4: General requirements
for safety — Collateral standard: Programmable electrical
medical systems
IEC 60601-1-4:1996

EN 60601-1-4:1996/A1:1999 8.11.1997 Note 3 Date expired

IEC 60601-1-4:1996/A1:1999 (*) (1.12.2002)

Cenelec EN 60601-1-6:2004 2.7.2006

Medical electrical equipment — Part 1-6: General requirements
for safety — Collateral standard: Usability
IEC 60601-1-6:2004 (*)
C 16/26 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-1-6:2007 27.11.2008 EN 60601-1-6:2004 1.6.2012

Medical electrical equipment — Part 1-6: General requirements Note 2.1
for basic safety and essential performance — Collateral
Standard: Usability
IEC 60601-1-6:2006 (*)

EN 60601-1-6:2007/AC:2010 This is the first

publication

Cenelec EN 60601-1-6:2010 This is the first EN 60601-1-6:2007 1.4.2013

Medical electrical equipment — Part 1-6: General requirements publication Note 2.1
for basic safety and essential performance — Collateral
standard: Usability
IEC 60601-1-6:2010 (*)

Cenelec EN 60601-1-8:2004 22.12.2007

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

EN 60601-1-8:2004/A1:2006 22.12.2007 Note 3 Date expired

IEC 60601-1-8:2003/A1:2006 (*) (1.1.2007)

Cenelec EN 60601-1-8:2007 27.11.2008 EN 60601-1-8:2004 1.6.2012

Medical electrical equipment — Part 1-8: General requirements and its amendment
for basic safety and essential performance — Collateral Note 2.1
Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical
systems
IEC 60601-1-8:2006 (*)

EN 60601-1-8:2007/AC:2010 This is the first

publication

Cenelec EN 60601-1-10:2008 27.11.2008

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 (*)

Cenelec EN 60601-1-11:2010 This is the first

Medical electrical equipment — Part 1-11: General requirements publication
for basic safety and essential performance — Collateral
standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment
IEC 60601-1-11:2010 (*)

Cenelec EN 60601-2-1:1998 14.11.2001

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

EN 60601-2-1:1998/A1:2002 13.12.2002 Note 3 Date expired

IEC 60601-2-1:1998/A1:2002 (*) (1.6.2005)
18.1.2011 EN Official Journal of the European Union C 16/27

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-2:2007 22.12.2007 EN 60601-2-2:2000 Date expired

Medical electrical equipment — Part 2-2: Particular Note 2.1 (1.10.2009)
requirements for the safety of high frequency surgical
equipment
IEC 60601-2-2:2006 (*)

Cenelec EN 60601-2-2:2009 7.7.2010 EN 60601-2-2:2007 1.4.2012

Medical electrical equipment — Part 2-2: Particular Note 2.1
requirements for the basic safety and essential performance of
high frequency surgical equipment and high frequency surgical
accessories
IEC 60601-2-2:2009 (*)

Cenelec EN 60601-2-3:1993 18.11.1995

Medical electrical equipment — Part 2: Particular requirements
for the safety of short-wave therapy equipment
IEC 60601-2-3:1991

EN 60601-2-3:1993/A1:1998 18.11.1995 Note 3 Date expired

IEC 60601-2-3:1991/A1:1998 (*) (1.7.2001)

Cenelec EN 60601-2-4:2003 15.10.2003

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 13.12.2002

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 9.10.1999

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

Cenelec EN 60601-2-8:1997 14.11.2001

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

EN 60601-2-8:1997/A1:1997 14.11.2001 Note 3 Date expired

IEC 60601-2-8:1987/A1:1997 (*) (1.7.1998)

Cenelec EN 60601-2-10:2000 13.12.2002

Medical electrical equipment — Part 2-10: Particular
requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10:1987

EN 60601-2-10:2000/A1:2001 13.12.2002 Note 3 Date expired

IEC 60601-2-10:1987/A1:2001 (*) (1.11.2004)

Cenelec EN 60601-2-11:1997 9.10.1999

Medical electrical equipment — Part 2-11: Particular
requirements for the safety of gamma beam therapy equipment
IEC 60601-2-11:1997
C 16/28 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

EN 60601-2-11:1997/A1:2004 9.10.1999 Note 3 Date expired

IEC 60601-2-11:1997/A1:2004 (*) (1.9.2007)

Cenelec EN 60601-2-12:2006 22.12.2007

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

Cenelec EN 60601-2-13:2006 22.12.2007

Medical electrical equipment — Part 2-13: Particular
requirements for the safety and essential performance of anaes­
thetic systems
IEC 60601-2-13:2003

EN 60601-2-13:2006/A1:2007 22.12.2007 Note 3 Date expired

IEC 60601-2-13:2003/A1:2006 (*) (1.3.2010)

Cenelec EN 60601-2-16:1998 9.10.1999

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

EN 60601-2-16:1998/AC:1999 This is the first

publication

Cenelec EN 60601-2-17:2004 8.11.2005 EN 60601-2-17:1996 Date expired

Medical electrical equipment — Part 2-17: Particular + A1:1996 (1.3.2007)
requirements for the safety of automatically-controlled brachy­ Note 2.1
therapy afterloading equipment
IEC 60601-2-17:2004 (*)

Cenelec EN 60601-2-18:1996 9.10.1999

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

EN 60601-2-18:1996/A1:2000 9.10.1999 Note 3 Date expired

IEC 60601-2-18:1996/A1:2000 (*) (1.8.2003)

Cenelec EN 60601-2-19:1996 9.10.1999

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

EN 60601-2-19:1996/A1:1996 9.10.1999 Note 3 Date expired

IEC 60601-2-19:1990/A1:1996 (*) (13.6.1998)
18.1.2011 EN Official Journal of the European Union C 16/29

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-19:2009 7.7.2010 EN 60601-2-19:1996 1.4.2012

Medical electrical equipment — Part 2-19: Particular and its amendment
requirements for the basic safety and essential performance of Note 2.1
infant incubators
IEC 60601-2-19:2009 (*)

Cenelec EN 60601-2-20:1996 9.10.1999

Medical electrical equipment — Part 2: Particular requirements
for the safety of transport incubators
IEC 60601-2-20:1990 + A1:1996 (*)

Cenelec EN 60601-2-20:2009 This is the first EN 60601-2-20:1996 1.9.2012

Medical electrical equipment — Part 2-20: Particular publication Note 2.1
requirements for the basic safety and essential performance of
infant transport incubators
IEC 60601-2-20:2009 (*)

Cenelec EN 60601-2-21:1994 18.11.1995

Medical electrical equipment — Part 2: Particular requirements
for the safety of infant radiant warmers
IEC 60601-2-21:1994

EN 60601-2-21:1994/A1:1996 23.8.2006 Note 3 Date expired

IEC 60601-2-21:1994/A1:1996 (*) (13.6.1998)

Cenelec EN 60601-2-21:2009 7.7.2010 EN 60601-2-21:1994 1.4.2012

Medical electrical equipment — Part 2-21: Particular and its amendment
requirements for the basic safety and essential performance of Note 2.1
infant radiant warmers
IEC 60601-2-21:2009 (*)

Cenelec EN 60601-2-22:1996 17.5.1997

Medical electrical equipment — Part 2: Particular requirements
for the safety of diagnostic and therapeutic laser equipment
IEC 60601-2-22:1995 (*)

Cenelec EN 60601-2-23:2000 14.11.2001 EN 60601-2-23:1997 Date expired

Medical electrical equipment — Part 2-23: Particular Note 2.1 (1.1.2003)
requirements for the safety, including essential performance,
of transcutaneous partial pressure monitoring equipment
IEC 60601-2-23:1999 (*)

Cenelec EN 60601-2-24:1998 9.10.1999

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 17.5.1997

Medical electrical equipment — Part 2-25: Particular
requirements for the safety of electrocardiographs
IEC 60601-2-25:1993

EN 60601-2-25:1995/A1:1999 13.12.2002 Note 3 Date expired

IEC 60601-2-25:1993/A1:1999 (*) (1.5.2002)
C 16/30 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-26:2003 8.11.2005 EN 60601-2-26:1994 Date expired

Medical electrical equipment — Part 2-26: Particular Note 2.1 (1.3.2006)
requirements for the safety of electroencephalographs
IEC 60601-2-26:2002 (*)

Cenelec EN 60601-2-27:2006 26.7.2006 EN 60601-2-27:1994 Date expired

Medical electrical equipment — Part 2-27: Particular Note 2.1 (1.11.2008)
requirements for the safety, including essential performance,
of electrocardiographic monitoring equipment
IEC 60601-2-27:2005 (*)

EN 60601-2-27:2006/AC:2006 This is the first

publication

Cenelec EN 60601-2-28:1993 18.11.1995

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 (*)

Cenelec EN 60601-2-28:2010 This is the first EN 60601-2-28:1993 1.4.2013

Medical electrical equipment — Part 2-28: Particular publication Note 2.1
requirements for the basic safety and essential performance of
X-ray tube assemblies for medical diagnosis
IEC 60601-2-28:2010 (*)

Cenelec EN 60601-2-29:1999 9.10.1999 EN 60601-2-29:1995 Date expired

Medical electrical equipment — Part 2-29: Particular + A1:1996 (1.4.2002)
requirements for the safety of radiotherapy simulators Note 2.1
IEC 60601-2-29:1999 (*)

Cenelec EN 60601-2-29:2008 15.7.2009 EN 60601-2-29:1999 1.11.2011

Medical electrical equipment — Part 2-29: Particular Note 2.1
requirements for the basic safety and essential performance of
radiotherapy simulators
IEC 60601-2-29:2008 (*)

Cenelec EN 60601-2-30:2000 14.11.2001 EN 60601-2-30:1995 Date expired

Medical electrical equipment — Part 2-30: Particular Note 2.1 (1.2.2003)
requirements for the safety, including essential performance,
of automatic cycling non-invasive blood pressure monitoring
equipment
IEC 60601-2-30:1999 (*)

Cenelec EN 60601-2-31:1995 18.11.1995

Medical electrical equipment — Part 2-31: Particular
requirements for the safety of external cardiac pacemakers
with internal power source
IEC 60601-2-31:1994

EN 60601-2-31:1995/A1:1998 14.11.2001 Note 3 Date expired

IEC 60601-2-31:1994/A1:1998 (*) (1.1.2001)

Cenelec EN 60601-2-32:1994 18.11.1995

Medical electrical equipment — Part 2: Particular requirements
for the safety of associated equipment of X-ray equipment
IEC 60601-2-32:1994 (*)
18.1.2011 EN Official Journal of the European Union C 16/31

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-33:2002 15.10.2003 EN 60601-2-33:1995 Date expired

Medical electrical equipment — Part 2-33: Particular + A11:1997 (1.7.2005)
requirements for the safety of magnetic resonance equipment Note 2.1
for medical diagnosis
IEC 60601-2-33:2002

EN 60601-2-33:2002/A1:2005 27.7.2006 Note 3 Date expired

IEC 60601-2-33:2002/A1:2005 (1.11.2008)

EN 60601-2-33:2002/A2:2008 27.11.2008 Note 3 1.2.2011

IEC 60601-2-33:2002/A2:2007 (*)

Cenelec EN 60601-2-34:2000 15.10.2003 EN 60601-2-34:1995 Date expired

Medical electrical equipment — Part 2-34: Particular Note 2.1 (1.11.2003)
requirements for the safety, including essential performance,
of invasive blood pressure monitoring equipment
IEC 60601-2-34:2000 (*)

Cenelec EN 60601-2-35:1996 9.10.1999

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 9.10.1999

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

Cenelec EN 60601-2-37:2001 13.12.2002

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

EN 60601-2-37:2001/A1:2005 8.11.2005 Note 3 Date expired

IEC 60601-2-37:2001/A1:2004 (1.1.2008)

EN 60601-2-37:2001/A2:2005 26.7.2006 Note 3 Date expired

IEC 60601-2-37:2001/A2:2005 (*) (1.1.2008)

Cenelec EN 60601-2-37:2008 27.11.2008 EN 60601-2-37:2001 Date expired

Medical electrical equipment — Part 2-37: Particular and its amendments (1.10.2010)
requirements for the basic safety and essential performance of Note 2.1
ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2007 (*)

Cenelec EN 60601-2-38:1996 9.10.1999

Medical electrical equipment — Part 2-38: Particular
requirements for the safety of electrically operated hospital beds
IEC 60601-2-38:1996

EN 60601-2-38:1996/A1:2000 14.11.2001 Note 3 Date expired

IEC 60601-2-38:1996/A1:1999 (*) (1.1.2003)
C 16/32 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-39:1999 14.11.2001

Medical electrical equipment — Part 2-39: Particular
requirements for the safety of peritoneal dialysis equipment
IEC 60601-2-39:1999 (*)

EN 60601-2-39:1999/AC:1999 This is the first

publication

Cenelec EN 60601-2-39:2008 27.11.2008 EN 60601-2-39:1999 1.3.2011

Medical electrical equipment — Part 2-39: Particular Note 2.1
requirements for basic safety and essential performance of peri­
toneal dialysis equipment
IEC 60601-2-39:2007 (*)

Cenelec EN 60601-2-40:1998 9.10.1999

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 14.11.2001

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

Cenelec EN 60601-2-41:2009 This is the first EN 60601-2-41:2000 1.11.2012

Medical electrical equipment — Part 2-41: Particular publication Note 2.1
requirements for basic safety and essential performance of
surgical luminaires and luminaires for diagnosis
IEC 60601-2-41:2009 (*)

Cenelec EN 60601-2-43:2000 13.12.2002

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

Cenelec EN 60601-2-43:2010 This is the first EN 60601-2-43:2000 1.6.2013

Medical electrical equipment — Part 2-43: Particular publication Note 2.1
requirements for basic safety and essential performance of
X-ray equipment for interventional procedures
IEC 60601-2-43:2010 (*)

Cenelec EN 60601-2-44:2001 14.11.2001 EN 60601-2-44:1999 Date expired

Medical electrical equipment — Part 2-44: Particular Note 2.1 (1.7.2004)
requirements for the safety of X-ray equipment for computed
tomography
IEC 60601-2-44:2001

EN 60601-2-44:2001/A1:2003 8.11.2005 Note 3 Date expired

IEC 60601-2-44:2001/A1:2002 (*) (1.12.2005)

Cenelec EN 60601-2-44:2009 7.7.2010 EN 60601-2-44:2001 1.5.2012

Medical electrical equipment — Part 2-44: Particular and its amendment
requirements for the basic safety and essential performance of Note 2.1
X-ray equipment for computed tomography
IEC 60601-2-44:2009 (*)
18.1.2011 EN Official Journal of the European Union C 16/33

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60601-2-45:2001 14.11.2001 EN 60601-2-45:1998 Date expired

Medical electrical equipment — Part 2-45: Particular Note 2.1 (1.7.2004)
requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
IEC 60601-2-45:2001 (*)

Cenelec EN 60601-2-46:1998 14.11.2001

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 13.12.2002

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 13.12.2002

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 13.12.2002

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

Cenelec EN 60601-2-50:2009 7.7.2010 EN 60601-2-50:2002 1.5.2012

Medical electrical equipment — Part 2-50: Particular Note 2.1
requirements for the basic safety and essential performance of
infant phototherapy equipment
IEC 60601-2-50:2009 (*)

Cenelec EN 60601-2-51:2003 24.6.2004

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

Cenelec EN 60601-2-54:2009 This is the first EN 60601-2-7:1998 1.8.2012

Medical electrical equipment — Part 2-54: Particular publication + EN 60601-2-28:1993
requirements for the basic safety and essential performance of + EN 60601-2-32:1994
X-ray equipment for radiography and radioscopy
Note 2.1
IEC 60601-2-54:2009 (*)

Cenelec EN 60627:2001 13.12.2002

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

EN 60627:2001/AC:2002 This is the first

publication
C 16/34 EN Official Journal of the European Union 18.1.2011

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 60645-1:2001 13.12.2002 EN 60645-1:1994 Date expired

Electroacoustics — Audiological equipment — Part 1: Pure-tone Note 2.1 (1.10.2004)
audiometers
IEC 60645-1:2001 (*)

Cenelec EN 60645-2:1997 17.5.1997

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

Cenelec EN 60645-3:2007 27.11.2008 EN 60645-3:1995 Date expired

Electroacoustics — Audiometric equipment — Part 3: Test Note 2.1 (1.6.2010)
signals of short duration
IEC 60645-3:2007 (*)

Cenelec EN 60645-4:1995 23.8.1996

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

Cenelec EN 61217:1996 14.11.2001

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

EN 61217:1996/A1:2001 14.11.2001 Note 3 Date expired

IEC 61217:1996/A1:2000 (1.12.2003)

EN 61217:1996/A2:2008 27.11.2008 Note 3 1.2.2011

IEC 61217:1996/A2:2007 (*)

Cenelec EN 61676:2002 15.10.2003

Medical electrical equipment — Dosimetric instruments used
for non-invasive measurement of X-ray tube voltage in diag­
nostic radiology
IEC 61676:2002

EN 61676:2002/A1:2009 7.7.2010 Note 3 1.3.2012

IEC 61676:2002/A1:2008 (*)

Cenelec EN 62083:2001 13.12.2002

Medical electrical equipment — Requirements for the safety of
radiotherapy treatment planning systems
IEC 62083:2000 (*)

Cenelec EN 62083:2009 This is the first EN 62083:2001 1.11.2012

Medical electrical equipment — Requirements for the safety of publication Note 2.1
radiotherapy treatment planning systems
IEC 62083:2009 (*)

Cenelec EN 62220-1:2004 24.6.2004

Medical electrical equipment — Characteristics of digital X-ray
imaging devices — Part 1: Determination of the detective
quantum efficiency
IEC 62220-1:2003 (*)
18.1.2011 EN Official Journal of the European Union C 16/35

Date of cessation of
Reference and title of the harmonised standard Reference of superseded presumption of conformity
ESO (1 ) First publication OJ
(and reference document) standard of superseded standard
Note 1

Cenelec EN 62220-1-2:2007 27.11.2008

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 (*)

Cenelec EN 62220-1-3:2008 15.7.2009

Medical electrical equipment — Characteristics of digital X-ray
imaging devices — Part 1-3: Determination of the detective
quantum efficiency — Detectors used in dynamic imaging
IEC 62220-1-3:2008 (*)

Cenelec EN 62304:2006 27.11.2008

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

EN 62304:2006/AC:2008 This is the first

publication

Cenelec EN 62366:2008 27.11.2008

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

Cenelec EN 80601-2-35:2009 This is the first EN 60601-2-35:1996 1.11.2012

Medical electrical equipment — Part 2-35: Particular publication Note 2.1
requirements for the basic safety and essential performance of
heating devices using blankets, pads and mattresses and
intended for heating in medical use
IEC 80601-2-35:2009 (*)

Cenelec EN 80601-2-58:2009 7.7.2010

Medical electrical equipment — Part 2-58: Particular
requirements for the basic safety and essential performance of
lens removal devices and vitrectomy devices for ophthalmic
surgery
IEC 80601-2-58:2008 (*)

Cenelec EN 80601-2-59:2009 This is the first

Medical electrical equipment — Part 2-59: Particular publication
requirements for the basic safety and essential performance of
screening thermographs for human febrile temperature
screening
IEC 80601-2-59:2008 (*)

(1) ESO: European Standards Organisation:

— CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIUQUE/BELGIЁ, Tel. +32 25500811, Fax +32 25500819 (http://www.cen.eu),
— Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIUQUE/BELGIЁ, Tel. +32 25196871, Fax +32 25196919 (http://www.cenelec.eu),
— ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200, Fax +33 493654716 (http://www.etsi.eu).
(*) This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

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.
C 16/36 EN Official Journal of the European Union 18.1.2011

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 2.2: The new standard has a broader scope than 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.

NOTE:

— Any information concerning the availability of the standards can be obtained either from the European
Standardisation Organisations or from the national standardisation bodies of which the list is annexed to
the Directive 98/34/EC of the European Parliament and Council (1) amended by the Directive
98/48/EC (2).

— Harmonised standards are adopted by the European Standardisation Organisations in English (CEN and
Cenelec also publish in French and German). Subsequently, the titles of the harmonised standards are
translated into all other required official languages of the European Union by the National Standards
Bodies. The European Commission is not responsible for the correctness of the titles which have been
presented for publication in the Official Journal.

— Publication of the references in the Official Journal of the European Union does not imply that the
standards are available in all the Community languages.

— This list replaces all the previous lists published in the Official Journal of the European Union. The
Commission ensures the updating of this list.

— More information about harmonised standards on the Internet at

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

(1) OJ L 204, 21.7.1998, p. 37.

(2) OJ L 217, 5.8.1998, p. 18.